Assessment of Three Basic Progressive Lens Designs

NCT ID: NCT05252871

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-09
• Study Completion Date: 2022-06-06

Brief 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.

Detailed Description

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental: The specified PAL design wearers

Subjects who have been already wearing any from specified design type of PAL

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

The other PAL design wearers

Subjects who have been already wearing any from the other design type of PAL

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoya Vision Care

INDUSTRY

Sponsor Role: collaborator

Western University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Spors, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Western University of Health Sciences

Locations

Western University of Health Sciences

Pomona, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P21/IRB/065

Identifier Type: -

Identifier Source: org_study_id