Assessment of Three Basic Progressive Lens Designs

Western University of Health Sciences80 enrolled

Overview

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.

The purpose of the study is to evaluate the preference, adaptability, and visual performance of three progressive lens designs. The difference in these lens designs is a variation of zone sizes for intermediate and near vision. The clinical trial helps manufacturers and eye care practitioners to give detailed suggestions to patients. Study participants will be experienced progressive addition lens wearers, which will be recruited by advertisements, by email, and with direct person-to-person solicitation. The study will be conducted at the Eye Care Institute at the Patient Care Center Western University of Health Sciences, Pomona, CA, 91766. For each participant, the study is completed in around two months and requires three separate visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Presbyopia

Interventions

Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coatingDEVICE

Subjects will be wearing three different PAL designs with different geometries of the optical progression.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Western University of Health Sciences

Pomona, California, United States

Outcomes

Primary Outcomes

Evaluate the Adaptation to Progressive Lens Designs.

Evaluate the adaptation to progressive lens designs through a "Satisfaction questionnaire" after 1 week of use of each of the 3 progressive addition lenses. Scale titles: Visual Quality Scale: A 5-point scale from a minimum value of 1 to a maximum score of 5. Higher scores mean better outcomes.

Time frame: Entire study duration (approx. 4 weeks)

Secondary Outcomes

Evaluate the Immediate Preference Among Progressive Lens Designs.

Evaluate the immediate preference for progressive lens designs through a "Satisfaction questionnaire" directly after receiving the 3 progressive addition lenses. Scale titles: Visual Quality Scale: A 5-point scale from a minimum value of 1 to a maximum score of 5. Higher scores mean better outcomes.

Time frame: Directly after receiving the lenses (approx. 15 minutes)

Evaluate the Preference of Progressive Lens Designs.

Evaluate the final preference of progressive lens designs after wearing each of the 3 PALs for one week. Scale title: Preference of Progressive Addition Lenses Scale: "Pair 1", "Pair 2, "Pair 3"

Time frame: Entire study duration (approx. 4 weeks)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.