N/A
Completed N=95
Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle
Source: ClinicalTrials.gov NCT01234207 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Visual Acuity, High Contrast, Distance Chart — -0.12; -0.11 logMAR
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity, High Contrast, Distance Chart |
-0.12; -0.11 | — |
| PRIMARY Visual Acuity, Low Contrast, Distance Chart |
0.01; 0.01 | — |
| PRIMARY Visual Acuity, High Contrast, Near Chart |
-0.11; -0.09 | — |
| PRIMARY Visual Acuity, Low Contrast, Near Chart |
0.05; 0.12 | — |
| PRIMARY 30-degree Off-axis Distance Visual Acuity, High Contrast Chart |
0.10; 0.10; 0.05; 0.04 | — |
| PRIMARY 30-degree Off-axis Distance Visual Acuity, Low Contrast Chart |
0.24; 0.24; 0.19; 0.16 | — |
| PRIMARY Horizontal Extent of Undistorted Vision at Reading Distance |
17.74; 20.06 | — |
| PRIMARY Questionnaire Battery |
45; 55; 40; 60; 40; 60 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01234207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.