Assessment of Three Basic Progressive Lens Designs

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pomona, California, United States, 91766
      • Western University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: The specified PAL design wearers; Subjects who have been already wearing any from specified design type of PAL	Device: 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.
Active Comparator: The other PAL design wearers; Subjects who have been already wearing any from the other design type of PAL	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Entire study duration (approx. 4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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"	Entire study duration (approx. 4 weeks)

Collaborators and Investigators

• Sponsor: Western University of Health Sciences
• Collaborators: Hoya Cooperation Vision Care
• Investigators: Principal Investigator: Frank Spors, Ph.D., Western University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: P21/IRB/065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes