Presbyopia
Conditions
Keywords
Progressive addition lenses, Customized free-form, Presbyopia, Bifocals, Subjective assessment, Visual performance, Visual acuity, Amsler grid
Brief summary
The purpose of this study was to compare objective clinical measures of visual performance and subjective measures of satisfaction and preference between standard progressive addition lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL spectacle.
Detailed description
In a double-masked crossover trial, 95 experienced wearers wore customized free-form PAL spectacles (Test) and standard non-free-form PAL spectacles (Control) for one week each. All subjects wore both Test and Control spectacles, and the pair to be worn first was randomly assigned. At dispensing and after 1 week of wear, subjects were tested for distance and near visual acuity (VA) under both high and low contrast; in addition, 30 degree off-axis VA was measured using a novel apparatus, as was the horizontal extent of undistorted vision at reading distance. Subjects also completed a set of questionnaires detailing their satisfaction levels, adaptation times, and preferences for Test or Control spectacles for different visual tasks.
Interventions
DEVICEStandard, non-free-form, non-customized PAL spectacles
Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.
DEVICEIndividually customized free-form surfaced PAL spectacles
Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
Sponsors
Carl Zeiss Meditec, Inc.
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
39 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Presbyope * Experienced PAL spectacle wearer * Correctable to at least 20/25 in both eyes * Able and willing to use Test and Control spectacles for 1 week each as primary form of presbyopia correction * Able and willing to complete all laboratory measurements and questionnaire batteries
Exclusion criteria
* Purchasing free-form PAL spectacles from the UC Berkeley Eyewear Center * Having eye conditions or diseases that could potentially cause a decrease in visual acuity over the course of participation in the study * Having eye conditions or diseases that could potentially interfere with ability to use Test and Control spectacles as primary form of presbyopia correction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity, High Contrast, Distance Chart | Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles | Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system. |
| Visual Acuity, Low Contrast, Distance Chart | Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles | Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system. |
| Visual Acuity, High Contrast, Near Chart | Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles | Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system. |
| Visual Acuity, Low Contrast, Near Chart | Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles | Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system. |
| 30-degree Off-axis Distance Visual Acuity, High Contrast Chart | Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles | Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart |
| 30-degree Off-axis Distance Visual Acuity, Low Contrast Chart | Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles | Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart |
| Horizontal Extent of Undistorted Vision at Reading Distance | Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles | Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid |
| Questionnaire Battery | At study exit, after both Test and Control spectacles had been worn for 1 week each | Forced-choice Likert scale preference questionnaire |
Countries
United States
Participant flow
Recruitment details
Presbyopic subjects were recruited from the population of patients who were purchasing non-free-form PAL spectacles with antireflective coating in new frames from the University of California, Berkeley School of Optometry Eyewear Center.
Pre-assignment details
95 subjects were recruited, all of whom met the eligibility criteria and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Crossover trial: all study participants received both Test and Control spectacles, in randomized order. | 95 |
| Total | 95 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants |
| Age, Continuous | 58.1 years STANDARD_DEVIATION 6.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Region of Enrollment United States | 95 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 95 |
| other Total, other adverse events | 0 / 95 | 0 / 95 |
| serious Total, serious adverse events | 0 / 95 | 0 / 95 |
Outcome results
Primary
30-degree Off-axis Distance Visual Acuity, High Contrast Chart
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Spectacles | 30-degree Off-axis Distance Visual Acuity, High Contrast Chart | Off-Axis Left | 0.10 logMAR | Standard Deviation 0.13 |
| Control Spectacles | 30-degree Off-axis Distance Visual Acuity, High Contrast Chart | Off-Axis Right | 0.05 logMAR | Standard Deviation 0.09 |
| Test Spectacles | 30-degree Off-axis Distance Visual Acuity, High Contrast Chart | Off-Axis Left | 0.10 logMAR | Standard Deviation 0.14 |
| Test Spectacles | 30-degree Off-axis Distance Visual Acuity, High Contrast Chart | Off-Axis Right | 0.04 logMAR | Standard Deviation 0.1 |
Primary
30-degree Off-axis Distance Visual Acuity, Low Contrast Chart
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Spectacles | 30-degree Off-axis Distance Visual Acuity, Low Contrast Chart | Off-Axis Left | 0.24 logMAR | Standard Deviation 0.12 |
| Control Spectacles | 30-degree Off-axis Distance Visual Acuity, Low Contrast Chart | Off-Axis Right | 0.19 logMAR | Standard Deviation 0.1 |
| Test Spectacles | 30-degree Off-axis Distance Visual Acuity, Low Contrast Chart | Off-Axis Left | 0.24 logMAR | Standard Deviation 0.12 |
| Test Spectacles | 30-degree Off-axis Distance Visual Acuity, Low Contrast Chart | Off-Axis Right | 0.16 logMAR | Standard Deviation 0.11 |
Primary
Horizontal Extent of Undistorted Vision at Reading Distance
Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Spectacles | Horizontal Extent of Undistorted Vision at Reading Distance | 17.74 cm | Standard Deviation 9.87 |
| Test Spectacles | Horizontal Extent of Undistorted Vision at Reading Distance | 20.06 cm | Standard Deviation 11.89 |
Primary
Questionnaire Battery
Forced-choice Likert scale preference questionnaire
Time frame: At study exit, after both Test and Control spectacles had been worn for 1 week each
Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Spectacles | Questionnaire Battery | Preference for Distance Vision | 40 percentage of participants |
| Control Spectacles | Questionnaire Battery | Overall Preference | 45 percentage of participants |
| Control Spectacles | Questionnaire Battery | Preference for Active Vision | 40 percentage of participants |
| Control Spectacles | Questionnaire Battery | Preference for Midrange Vision | 45 percentage of participants |
| Control Spectacles | Questionnaire Battery | Preference for Transitional Vision | 45 percentage of participants |
| Control Spectacles | Questionnaire Battery | Preference for Near Vision | 50 percentage of participants |
| Test Spectacles | Questionnaire Battery | Preference for Transitional Vision | 55 percentage of participants |
| Test Spectacles | Questionnaire Battery | Preference for Midrange Vision | 55 percentage of participants |
| Test Spectacles | Questionnaire Battery | Overall Preference | 55 percentage of participants |
| Test Spectacles | Questionnaire Battery | Preference for Distance Vision | 60 percentage of participants |
| Test Spectacles | Questionnaire Battery | Preference for Near Vision | 50 percentage of participants |
| Test Spectacles | Questionnaire Battery | Preference for Active Vision | 60 percentage of participants |
Primary
Visual Acuity, High Contrast, Distance Chart
Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Spectacles | Visual Acuity, High Contrast, Distance Chart | -0.12 logMAR | Standard Deviation 0.06 |
| Test Spectacles | Visual Acuity, High Contrast, Distance Chart | -0.11 logMAR | Standard Deviation 0.07 |
Primary
Visual Acuity, High Contrast, Near Chart
Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Spectacles | Visual Acuity, High Contrast, Near Chart | -0.11 logMAR | Standard Deviation 0.13 |
| Test Spectacles | Visual Acuity, High Contrast, Near Chart | -0.09 logMAR | Standard Deviation 0.09 |
Primary
Visual Acuity, Low Contrast, Distance Chart
Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Spectacles | Visual Acuity, Low Contrast, Distance Chart | 0.01 logMAR | Standard Deviation 0.07 |
| Test Spectacles | Visual Acuity, Low Contrast, Distance Chart | 0.01 logMAR | Standard Deviation 0.07 |
Primary
Visual Acuity, Low Contrast, Near Chart
Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
Time frame: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
Population: 95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Spectacles | Visual Acuity, Low Contrast, Near Chart | 0.05 logMAR | Standard Deviation 0.09 |
| Test Spectacles | Visual Acuity, Low Contrast, Near Chart | 0.12 logMAR | Standard Deviation 0.64 |