Vision, Low
Conditions
Brief summary
This study tests the hypothesis that objectively derived spectacle prescriptions based on wavefront aberration measurements of the eyes of individuals with Down syndrome can provide an improvement in visual acuity over that obtained with spectacle prescriptions based on standard clinical prescribing techniques. The objectively derived prescriptions are derived using strategies to optimize retinal image quality as measured by image quality metrics, and thus these prescriptions will be referred to as metric-derived.
Detailed description
Individuals with Down syndrome suffer from significant ocular complications including high levels of lower-order refractive error (sphere and cylinder) and elevated levels of higher-order aberrations. These optical factors likely contribute to the poor acuity observed in this population. Current clinical prescribing practices may under-serve this community, as the cognitive demands of the subjective refraction sequence are difficult for this population and often leave clinicians to prescribe from objective clinical findings that target full correction of sphero-cylindrical refractive error. This prescribing practice can lead to sub-par outcomes given the fact that full lower-order corrections can exacerbate the effects of higher-order aberrations in more aberrated eyes. For this study, individuals with Down syndrome will be dispensed three pairs of spectacles for 2 months each, in random order: one clinically-derived, and two objectively-derived refractions based upon methods designed to optimize a given metric of retinal image quality which takes into consideration the wavefront aberration measurements of the eye. Both initial and adapted visual acuity in the presence of each correction will be evaluated to determine whether the objectively-derived refractions outperform clinically-derived refractions.
Interventions
DEVICESpectacles - Clinically Derived
Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.
DEVICESpectacles - Metric Technique #1 Derived
Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.
DEVICESpectacles - Metric Technique #2 Derived
Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.
Sponsors
University of Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Down syndrome
Exclusion criteria
* Nystagmus (Involuntary beating movement of the eyes) * Visually significant media opacities (e.g. cataracts or corneal scars) * Strabismic amblyopia (reduced vision in one eye related to a constant eye-turn) * Anisometropic amblyopia (reduced vision in one eye related to a long-standing uncompensated difference in prescription between the two eyes)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adapted Visual Acuity | two months | Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spectacle Assessment Survey Question 1 | two months | Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'Do you like wearing this pair of glasses?' Responses were coded 1 through 5 with 5 = large smile. |
| Initial Visual Acuity | 1 day | Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters. |
| Spectacle Wear Time | two months | Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple. |
| Spectacle Assessment Survey Question 2 | two months | Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking far away?' Responses were coded 1 through 5 with 5 = large smile. |
| Spectacle Assessment Survey Question 3 | two months | Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking up close?' Responses were coded 1 through 5 with 5 = large smile. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinical, Then Metric #1, Then Metric #2 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.
Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.
Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).
Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | 5 |
| Clinical, Then Metric #2, Then Metric #1 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.
Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.
Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).
Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | 5 |
| Metric #1, Then Clinical, Then Metric #2 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.
Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.
Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).
Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | 5 |
| Metric #2, Then Clinical, Then Metric #1 Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.
Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.
Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).
Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | 5 |
| Metric #1, Then Metric #2, Then Clinical Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.
Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.
Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).
Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | 5 |
| Metric #2, Then Metric #1, Then Clinical Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.
Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.
Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).
Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | 5 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Treatment 2 Dispense to 2 Months Wear | Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Metric #2, Then Metric #1, Then Clinical | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Clinical, Then Metric #1, Then Metric #2 |
|---|---|---|---|---|---|---|---|
| Adaptive Behavior Standard Score | 60 Standard Score | 59 Standard Score | 57 Standard Score | 60 Standard Score | 59 Standard Score | 73 Standard Score | 74 Standard Score |
| Age, Continuous | 29 years STANDARD_DEVIATION 10 | 28 years STANDARD_DEVIATION 10 | 24 years STANDARD_DEVIATION 4 | 28 years STANDARD_DEVIATION 12 | 34 years STANDARD_DEVIATION 9 | 30 years STANDARD_DEVIATION 13 | 32 years STANDARD_DEVIATION 9 |
| Autorefraction Cylinder OD | -2.14 Diopters STANDARD_DEVIATION 1.58 | -1.35 Diopters STANDARD_DEVIATION 0.68 | -1.50 Diopters STANDARD_DEVIATION 0.68 | -2.25 Diopters STANDARD_DEVIATION 1.08 | -2.65 Diopters STANDARD_DEVIATION 2.91 | -3.65 Diopters STANDARD_DEVIATION 1.43 | -1.45 Diopters STANDARD_DEVIATION 0.67 |
| Autorefraction Cylinder OS | -2.07 Diopters STANDARD_DEVIATION 1.3 | -2.05 Diopters STANDARD_DEVIATION 0.37 | -1.95 Diopters STANDARD_DEVIATION 1.45 | -2.10 Diopters STANDARD_DEVIATION 0.42 | -1.55 Diopters STANDARD_DEVIATION 1.81 | -3.60 Diopters STANDARD_DEVIATION 1.32 | -1.15 Diopters STANDARD_DEVIATION 0.68 |
| Autorefraction Spherical Equivalent OD | -1.58 Diopters STANDARD_DEVIATION 4.88 | -5.23 Diopters STANDARD_DEVIATION 4.75 | -1.75 Diopters STANDARD_DEVIATION 4.37 | 0.98 Diopters STANDARD_DEVIATION 1.27 | -3.73 Diopters STANDARD_DEVIATION 7.33 | 1.93 Diopters STANDARD_DEVIATION 3.07 | -1.68 Diopters STANDARD_DEVIATION 4.53 |
| Autorefraction Spherical Equivalent OS | -1.32 Diopters STANDARD_DEVIATION 4.59 | -3.53 Diopters STANDARD_DEVIATION 3.73 | -1.58 Diopters STANDARD_DEVIATION 4.55 | -0.05 Diopters STANDARD_DEVIATION 2.43 | -2.68 Diopters STANDARD_DEVIATION 6.81 | 1.95 Diopters STANDARD_DEVIATION 2.52 | -2.03 Diopters STANDARD_DEVIATION 5.91 |
| Binocular Distance Visual Acuity | 0.39 logMAR STANDARD_DEVIATION 0.17 | 0.30 logMAR STANDARD_DEVIATION 0.14 | 0.46 logMAR STANDARD_DEVIATION 0.16 | 0.38 logMAR STANDARD_DEVIATION 0.15 | 0.40 logMAR STANDARD_DEVIATION 0.13 | 0.48 logMAR STANDARD_DEVIATION 0.29 | 0.30 logMAR STANDARD_DEVIATION 0.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number presenting with spectacles | 21 Participants | 4 Participants | 2 Participants | 4 Participants | 3 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 4 Participants | 5 Participants | 3 Participants | 5 Participants | 3 Participants | 3 Participants |
| Refractive Error Classification Emmetropia | 1 Number of Eyes | 0 Number of Eyes | 1 Number of Eyes | 0 Number of Eyes | 0 Number of Eyes | 0 Number of Eyes | 0 Number of Eyes |
| Refractive Error Classification Hyperopia | 21 Number of Eyes | 3 Number of Eyes | 1 Number of Eyes | 4 Number of Eyes | 3 Number of Eyes | 6 Number of Eyes | 4 Number of Eyes |
| Refractive Error Classification Mixed Astigmatism | 15 Number of Eyes | 3 Number of Eyes | 0 Number of Eyes | 5 Number of Eyes | 3 Number of Eyes | 3 Number of Eyes | 1 Number of Eyes |
| Refractive Error Classification Myopia | 23 Number of Eyes | 4 Number of Eyes | 8 Number of Eyes | 1 Number of Eyes | 4 Number of Eyes | 1 Number of Eyes | 5 Number of Eyes |
| Region of Enrollment United States | 30 participants | 5 participants | 5 participants | 5 participants | 5 participants | 5 participants | 5 participants |
| Sex: Female, Male Female | 15 Participants | 4 Participants | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 15 Participants | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 7 / 29 | 5 / 30 | 4 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Adapted Visual Acuity
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
Time frame: two months
Population: Spectacles from the clinical treatment method were not dispensed to one participant in the Metric #1, then Clinical, then Metric #2 group due to failure of the safety criteria required for dispense. This spectacle prescription resulted in visual acuity worse than 7 letters from the participant's presenting acuity to the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinical, Then Metric #1, Then Metric #2 | Adapted Visual Acuity | Period 3 Treatment 2 Dispense to 2 Months Wear | 0.272 logMAR | Standard Deviation 0.135 |
| Clinical, Then Metric #1, Then Metric #2 | Adapted Visual Acuity | Period 2 Treatment 1 Dispense to 2 Months Wear | 0.256 logMAR | Standard Deviation 0.11 |
| Clinical, Then Metric #1, Then Metric #2 | Adapted Visual Acuity | Period 4 Treatment 3 Dispense to 2 Months Wear | 0.288 logMAR | Standard Deviation 0.1 |
| Clinical, Then Metric #2, Then Metric #1 | Adapted Visual Acuity | Period 3 Treatment 2 Dispense to 2 Months Wear | 0.412 logMAR | Standard Deviation 0.215 |
| Clinical, Then Metric #2, Then Metric #1 | Adapted Visual Acuity | Period 2 Treatment 1 Dispense to 2 Months Wear | 0.440 logMAR | Standard Deviation 0.24 |
| Clinical, Then Metric #2, Then Metric #1 | Adapted Visual Acuity | Period 4 Treatment 3 Dispense to 2 Months Wear | 0.424 logMAR | Standard Deviation 0.238 |
| Metric #1, Then Clinical, Then Metric #2 | Adapted Visual Acuity | Period 3 Treatment 2 Dispense to 2 Months Wear | 0.370 logMAR | Standard Deviation 0.093 |
| Metric #1, Then Clinical, Then Metric #2 | Adapted Visual Acuity | Period 2 Treatment 1 Dispense to 2 Months Wear | 0.356 logMAR | Standard Deviation 0.149 |
| Metric #1, Then Clinical, Then Metric #2 | Adapted Visual Acuity | Period 4 Treatment 3 Dispense to 2 Months Wear | 0.320 logMAR | Standard Deviation 0.117 |
| Metric #2, Then Clinical, Then Metric #1 | Adapted Visual Acuity | Period 3 Treatment 2 Dispense to 2 Months Wear | 0.316 logMAR | Standard Deviation 0.157 |
| Metric #2, Then Clinical, Then Metric #1 | Adapted Visual Acuity | Period 2 Treatment 1 Dispense to 2 Months Wear | 0.284 logMAR | Standard Deviation 0.089 |
| Metric #2, Then Clinical, Then Metric #1 | Adapted Visual Acuity | Period 4 Treatment 3 Dispense to 2 Months Wear | 0.276 logMAR | Standard Deviation 0.14 |
| Metric #1, Then Metric #2, Then Clinical | Adapted Visual Acuity | Period 3 Treatment 2 Dispense to 2 Months Wear | 0.256 logMAR | Standard Deviation 0.344 |
| Metric #1, Then Metric #2, Then Clinical | Adapted Visual Acuity | Period 2 Treatment 1 Dispense to 2 Months Wear | 0.300 logMAR | Standard Deviation 0.163 |
| Metric #1, Then Metric #2, Then Clinical | Adapted Visual Acuity | Period 4 Treatment 3 Dispense to 2 Months Wear | 0.216 logMAR | Standard Deviation 0.119 |
| Metric #2, Then Metric #1, Then Clinical | Adapted Visual Acuity | Period 2 Treatment 1 Dispense to 2 Months Wear | 0.364 logMAR | Standard Deviation 0.048 |
| Metric #2, Then Metric #1, Then Clinical | Adapted Visual Acuity | Period 4 Treatment 3 Dispense to 2 Months Wear | 0.372 logMAR | Standard Deviation 0.091 |
| Metric #2, Then Metric #1, Then Clinical | Adapted Visual Acuity | Period 3 Treatment 2 Dispense to 2 Months Wear | 0.316 logMAR | Standard Deviation 0.091 |
Comparison: It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.p-value: 0.341Mixed Models Analysis
95% CI: [0.26, 0.36]
95% CI: [0.27, 0.38]
95% CI: [0.28, 0.39]
Secondary
Initial Visual Acuity
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinical, Then Metric #1, Then Metric #2 | Initial Visual Acuity | Treatment 2 Initial Dispense | 0.25 logMAR | Standard Deviation 0.08 |
| Clinical, Then Metric #1, Then Metric #2 | Initial Visual Acuity | Treatment 1 Initial Dispense | 0.28 logMAR | Standard Deviation 0.14 |
| Clinical, Then Metric #1, Then Metric #2 | Initial Visual Acuity | Treatment 3 Initial Dispense | 0.31 logMAR | Standard Deviation 0.4 |
| Clinical, Then Metric #2, Then Metric #1 | Initial Visual Acuity | Treatment 2 Initial Dispense | 0.43 logMAR | Standard Deviation 0.25 |
| Clinical, Then Metric #2, Then Metric #1 | Initial Visual Acuity | Treatment 1 Initial Dispense | 0.43 logMAR | Standard Deviation 0.25 |
| Clinical, Then Metric #2, Then Metric #1 | Initial Visual Acuity | Treatment 3 Initial Dispense | 0.44 logMAR | Standard Deviation 0.24 |
| Metric #1, Then Clinical, Then Metric #2 | Initial Visual Acuity | Treatment 2 Initial Dispense | 0.36 logMAR | Standard Deviation 0.18 |
| Metric #1, Then Clinical, Then Metric #2 | Initial Visual Acuity | Treatment 1 Initial Dispense | 0.34 logMAR | Standard Deviation 0.22 |
| Metric #1, Then Clinical, Then Metric #2 | Initial Visual Acuity | Treatment 3 Initial Dispense | 0.40 logMAR | Standard Deviation 0.16 |
| Metric #2, Then Clinical, Then Metric #1 | Initial Visual Acuity | Treatment 2 Initial Dispense | 0.30 logMAR | Standard Deviation 0.22 |
| Metric #2, Then Clinical, Then Metric #1 | Initial Visual Acuity | Treatment 1 Initial Dispense | 0.28 logMAR | Standard Deviation 0.13 |
| Metric #2, Then Clinical, Then Metric #1 | Initial Visual Acuity | Treatment 3 Initial Dispense | 0.32 logMAR | Standard Deviation 0.18 |
| Metric #1, Then Metric #2, Then Clinical | Initial Visual Acuity | Treatment 2 Initial Dispense | 0.30 logMAR | Standard Deviation 0.15 |
| Metric #1, Then Metric #2, Then Clinical | Initial Visual Acuity | Treatment 1 Initial Dispense | 0.29 logMAR | Standard Deviation 0.35 |
| Metric #1, Then Metric #2, Then Clinical | Initial Visual Acuity | Treatment 3 Initial Dispense | 0.28 logMAR | Standard Deviation 0.14 |
| Metric #2, Then Metric #1, Then Clinical | Initial Visual Acuity | Treatment 1 Initial Dispense | 0.33 logMAR | Standard Deviation 0.09 |
| Metric #2, Then Metric #1, Then Clinical | Initial Visual Acuity | Treatment 3 Initial Dispense | 0.40 logMAR | Standard Deviation 0.05 |
| Metric #2, Then Metric #1, Then Clinical | Initial Visual Acuity | Treatment 2 Initial Dispense | 0.34 logMAR | Standard Deviation 0.07 |
Comparison: It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.p-value: 0.41f test
95% CI: [0.28, 0.41]
95% CI: [0.26, 0.39]
95% CI: [0.28, 0.41]
Secondary
Spectacle Assessment Survey Question 1
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'Do you like wearing this pair of glasses?' Responses were coded 1 through 5 with 5 = large smile.
Time frame: two months
Population: A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Assessment Survey Question 1 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Assessment Survey Question 1 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Assessment Survey Question 1 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Assessment Survey Question 1 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Assessment Survey Question 1 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Assessment Survey Question 1 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Assessment Survey Question 1 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Assessment Survey Question 1 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Assessment Survey Question 1 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Assessment Survey Question 1 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Assessment Survey Question 1 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Assessment Survey Question 1 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Assessment Survey Question 1 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Assessment Survey Question 1 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Assessment Survey Question 1 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Assessment Survey Question 1 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Assessment Survey Question 1 | Period 4 Treatment 3 Dispense to 2 Months Wear | 4 score on a scale |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Assessment Survey Question 1 | Period 3 Treatment 2 Dispense to 2 Months Wear | 4 score on a scale |
Comparison: It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).p-value: 0.562Mixed Models Analysis
Secondary
Spectacle Assessment Survey Question 2
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking far away?' Responses were coded 1 through 5 with 5 = large smile.
Time frame: two months
Population: A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Assessment Survey Question 2 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Assessment Survey Question 2 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Assessment Survey Question 2 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Assessment Survey Question 2 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Assessment Survey Question 2 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Assessment Survey Question 2 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Assessment Survey Question 2 | Period 3 Treatment 2 Dispense to 2 Months Wear | 4.5 score on a scale |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Assessment Survey Question 2 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Assessment Survey Question 2 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Assessment Survey Question 2 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Assessment Survey Question 2 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Assessment Survey Question 2 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Assessment Survey Question 2 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Assessment Survey Question 2 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Assessment Survey Question 2 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Assessment Survey Question 2 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Assessment Survey Question 2 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Assessment Survey Question 2 | Period 3 Treatment 2 Dispense to 2 Months Wear | 4 score on a scale |
Comparison: It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).p-value: >0.99Mixed Models Analysis
Secondary
Spectacle Assessment Survey Question 3
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking up close?' Responses were coded 1 through 5 with 5 = large smile.
Time frame: two months
Population: A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Assessment Survey Question 3 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Assessment Survey Question 3 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Assessment Survey Question 3 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Assessment Survey Question 3 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Assessment Survey Question 3 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Assessment Survey Question 3 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Assessment Survey Question 3 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Assessment Survey Question 3 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Assessment Survey Question 3 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Assessment Survey Question 3 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Assessment Survey Question 3 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Assessment Survey Question 3 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Assessment Survey Question 3 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Assessment Survey Question 3 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Assessment Survey Question 3 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Assessment Survey Question 3 | Period 2 Treatment 1 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Assessment Survey Question 3 | Period 4 Treatment 3 Dispense to 2 Months Wear | 5 score on a scale |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Assessment Survey Question 3 | Period 3 Treatment 2 Dispense to 2 Months Wear | 5 score on a scale |
Comparison: It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).p-value: >0.99Mixed Models Analysis
Secondary
Spectacle Wear Time
Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple.
Time frame: two months
Population: For Period 3, one participant in group Metric #1, then Clinical, then Metric #2 did not receive the Clinical spectacle treatment because it failed the safety criteria for dispense. The clinical treatment for that participant reduced visual acuity greater than 7 letters from presenting acuity.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Wear Time | Period 3 Treatment 2 Dispense to 2 Months Wear | 9.50 Hours | Standard Deviation 5.5 |
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Wear Time | Period 4 Treatment 3 Dispense to 2 Months Wear | 11.61 Hours | Standard Deviation 6.05 |
| Clinical, Then Metric #1, Then Metric #2 | Spectacle Wear Time | Period 2 Treatment 1 Dispense to 2 Months Wear | 11.93 Hours | Standard Deviation 4.95 |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Wear Time | Period 3 Treatment 2 Dispense to 2 Months Wear | 12.68 Hours | Standard Deviation 5.82 |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Wear Time | Period 4 Treatment 3 Dispense to 2 Months Wear | 13.32 Hours | Standard Deviation 4.53 |
| Clinical, Then Metric #2, Then Metric #1 | Spectacle Wear Time | Period 2 Treatment 1 Dispense to 2 Months Wear | 13.15 Hours | Standard Deviation 3.96 |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Wear Time | Period 4 Treatment 3 Dispense to 2 Months Wear | 11.95 Hours | Standard Deviation 4.18 |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Wear Time | Period 2 Treatment 1 Dispense to 2 Months Wear | 10.48 Hours | Standard Deviation 4.08 |
| Metric #1, Then Clinical, Then Metric #2 | Spectacle Wear Time | Period 3 Treatment 2 Dispense to 2 Months Wear | 12.31 Hours | Standard Deviation 4.74 |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Wear Time | Period 2 Treatment 1 Dispense to 2 Months Wear | 9.81 Hours | Standard Deviation 4.32 |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Wear Time | Period 3 Treatment 2 Dispense to 2 Months Wear | 9.67 Hours | Standard Deviation 4.85 |
| Metric #2, Then Clinical, Then Metric #1 | Spectacle Wear Time | Period 4 Treatment 3 Dispense to 2 Months Wear | 9.47 Hours | Standard Deviation 5.12 |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Wear Time | Period 4 Treatment 3 Dispense to 2 Months Wear | 9.54 Hours | Standard Deviation 4.34 |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Wear Time | Period 2 Treatment 1 Dispense to 2 Months Wear | 8.40 Hours | Standard Deviation 4.29 |
| Metric #1, Then Metric #2, Then Clinical | Spectacle Wear Time | Period 3 Treatment 2 Dispense to 2 Months Wear | 9.26 Hours | Standard Deviation 4.17 |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Wear Time | Period 3 Treatment 2 Dispense to 2 Months Wear | 11.25 Hours | Standard Deviation 2.96 |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Wear Time | Period 2 Treatment 1 Dispense to 2 Months Wear | 11.62 Hours | Standard Deviation 2.55 |
| Metric #2, Then Metric #1, Then Clinical | Spectacle Wear Time | Period 4 Treatment 3 Dispense to 2 Months Wear | 11.31 Hours | Standard Deviation 3.06 |
Comparison: It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.p-value: 0.351f test
95% CI: [9.3, 12.7]
95% CI: [9.2, 12.6]
95% CI: [9.5, 12.9]