N/A
N=80
Assessment of Three Basic Progressive Lens Designs
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT05252871 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Evaluate the Adaptation to Progressive Lens Designs. — 4.125; 4.025; 3.875; 3.725 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Western University of Health Sciences
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Adaptation to Progressive Lens Designs. |
4.125; 4.025; 3.875; 3.725; 4.300; 4.150 | — |
| SECONDARY Evaluate the Immediate Preference Among Progressive Lens Designs. |
4.550; 4.400; 4.625; 4.450; 4.625; 4.400 | — |
| SECONDARY Evaluate the Preference of Progressive Lens Designs. |
11; 16; 10; 9; 19; 15 | — |
Summary
This clinical trial investigates the differences between three different progressive addition lens designs. It is a non-invasive double-masked randomized clinical investigation. For this study, 80 participants will be recruited.
Eligibility Criteria
Inclusion Criteria
- Age: 45 to 70 years old.
- Visual Acuity: far & near monocular: cc ≥ 20/20 (decimal cc ≥ 1.0)
- Normal binocular vision (at distance & near: no strabismus on cover testing, aligning prism of less than 2Δ horizontally or vertically, stereoacuity of 2' or better at distance and near).
- Prescription is in the range:
- Spherical power: less than +/-6.00 D
- Cylindrical power: less than -2.75 D
- Addition: 1.50 D - 2.50 D
- Difference in power (spherical equivalent) between eyes: less than 2.00 D
Exclusion Criteria
- Have never worn any progressive lens design.
- First prescription for progressive lenses.
- Prescription found during visit#1 varies from current prescription more than 0.50 D in any meridian.
- Currently wearing single vision lenses with accommodative support.
- Double vision or prismatic prescription in current glasses.
- Known ocular disease including strabismus, any pathology, any eye surgeries that may affect visual acuity.
- Use of systemic or ocular medications that are likely to affect vision.
- Balance problem/vertigo problem.
- Concurrent participation in other vision-related research.
Data sourced from ClinicalTrials.gov (NCT05252871). 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.