Cataract
Conditions
Keywords
Panoptix, trifocal IOL, multifocal IOL
Brief summary
This is a study to assess the spectacle independence and quality of vision of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.
Detailed description
This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.
Interventions
DEVICEPanoptix
Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Sponsors
Science in Vision
SightTrust Eye Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. * Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option * Gender: Males and Females. * Age: 40 or older. * Willing and able to provide written informed consent for participation in the study. * Willing and able to comply with scheduled visits and other study procedures. * Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or a toric IOL in the approved ranged for the Panoptix lens. * Have 20/32 (0.2 logMAR) or better potential acuity in both eyes
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Emmetropic Subjects Who Are Spectacle Independent | 3 months | Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - a little of the time or none of the time). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Uncorrected Intermediate Visual Acuity | 3 months | Binocular logMAR uncorrected intermediate visual acuity |
| Binocular Uncorrected Near Visual Acuity | 3 months | Binocular logMAR uncorrected near visual acuity |
| Binocular Corrected Distance Visual Acuity | 3 months | Binocular logMAR corrected distance visual acuity |
| Binocular Distance-corrected Intermediate Visual Acuity | 3 months | Binocular distance-corrected intermediate visual acuity in logMAR |
| Binocular Uncorrected Distance Visual Acuity | 3 months | Binocular logMAR uncorrected distance visual acuity |
| Spherical Equivalent Refraction | 3 months | Spherical equivalent refraction in diopters |
| Residual Refractive Cylinder | 3 months | Residual refractive cylinder in diopters |
| Quality of Vision Questionnaire | 3 months | Quality of Vision questionnaire results. This is a Rasch-scaled test with scores from 0-100, with lower being better. |
| Overall Spectacle Independence | 3 months | percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the PRSIQ - a little of the time or none of the time) |
| Binocular Distance-corrected Near Visual Acuity | 3 months | Binocular logMAR distance-corrected near visual acuity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Panoptix Patients bilaterally implanted with the Panoptix intraocular lens.
Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL) | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Panoptix | — |
|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 29 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Emmetropic Subjects Who Are Spectacle Independent
Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - a little of the time or none of the time).
Time frame: 3 months
Population: This is the number of emmetropic subjects (subgroup)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Panoptix | Number of Emmetropic Subjects Who Are Spectacle Independent | 21 Participants |
Secondary
Binocular Corrected Distance Visual Acuity
Binocular logMAR corrected distance visual acuity
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panoptix | Binocular Corrected Distance Visual Acuity | 0.03 logMAR Acuity | Standard Deviation 0.07 |
Secondary
Binocular Distance-corrected Intermediate Visual Acuity
Binocular distance-corrected intermediate visual acuity in logMAR
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panoptix | Binocular Distance-corrected Intermediate Visual Acuity | 0.06 logMAR Acuity | Standard Deviation 0.1 |
Secondary
Binocular Distance-corrected Near Visual Acuity
Binocular logMAR distance-corrected near visual acuity
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panoptix | Binocular Distance-corrected Near Visual Acuity | 0.05 logMAR Acuity | Standard Deviation 0.11 |
Secondary
Binocular Uncorrected Distance Visual Acuity
Binocular logMAR uncorrected distance visual acuity
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panoptix | Binocular Uncorrected Distance Visual Acuity | 0.07 logMAR | Standard Deviation 0.09 |
Secondary
Binocular Uncorrected Intermediate Visual Acuity
Binocular logMAR uncorrected intermediate visual acuity
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panoptix | Binocular Uncorrected Intermediate Visual Acuity | 0.09 logMAR | Standard Deviation 0.13 |
Secondary
Binocular Uncorrected Near Visual Acuity
Binocular logMAR uncorrected near visual acuity
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panoptix | Binocular Uncorrected Near Visual Acuity | 0.07 logMAR Acuity | Standard Deviation 0.11 |
Secondary
Overall Spectacle Independence
percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the PRSIQ - a little of the time or none of the time)
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Panoptix | Overall Spectacle Independence | 29 Participants |
Secondary
Quality of Vision Questionnaire
Quality of Vision questionnaire results. This is a Rasch-scaled test with scores from 0-100, with lower being better.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Panoptix | Quality of Vision Questionnaire | Severity | 30.6 Score on a scale (0-100, 0 is best) | Standard Deviation 15.1 |
| Panoptix | Quality of Vision Questionnaire | Frequency | 36.9 Score on a scale (0-100, 0 is best) | Standard Deviation 16.6 |
| Panoptix | Quality of Vision Questionnaire | Degree of bother | 28.7 Score on a scale (0-100, 0 is best) | Standard Deviation 20.7 |
Secondary
Residual Refractive Cylinder
Residual refractive cylinder in diopters
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panoptix | Residual Refractive Cylinder | 0.49 diopters | Standard Deviation 0.36 |
Secondary
Spherical Equivalent Refraction
Spherical equivalent refraction in diopters
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panoptix | Spherical Equivalent Refraction | 0.06 diopters | Standard Deviation 0.53 |