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Assessment of Three Basic Progressive Lens Designs

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating
Sponsored by
Western University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Western University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: The specified PAL design wearers

The other PAL design wearers

Arm Description

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

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

Outcomes

Primary Outcome Measures

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. The "Satisfaction questionnaire" assesses: visual comfort, visual acuity at far distances, intermediate, and near distances, and visual fields at far distances, intermediate, and near distances. Each is evaluated on a 5-point scale from 5 (very comfortable) to 1 (very uncomfortable).

Secondary Outcome Measures

Evaluate the preference among progressive lens designs.
Evaluate the preference among progressive lens designs through a "Final comparison questionnaire". The survey asks to rank the three pairs of glasses ("The best", "Good", "The worst") with respect to which provides a better distance visual acuity (seeing clear and sharp), wider field of view, and having the least perceived swaying/floating effects. The ranking is conducted for distance, intermediate, and near vision.
Evaluate the fast impression of progressive lens designs.
Evaluate first impression of progressive lens designs through a "First impression questionnaire" after 10-15 minutes of wearing each of the 3 PALs. The "First impression questionnaire" scale is (a) very comfortable, (b) comfortable, (c) adequate, (d) slightly uncomfortable, (e) uncomfortable.

Full Information

First Posted
January 3, 2022
Last Updated
July 13, 2022
Sponsor
Western University of Health Sciences
Collaborators
Hoya Cooperation Vision Care
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1. Study Identification

Unique Protocol Identification Number
NCT05252871
Brief Title
Assessment of Three Basic Progressive Lens Designs
Official Title
Assessment of Three Basic Progressive Lens Designs
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
June 6, 2022 (Actual)
Study Completion Date
June 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University of Health Sciences
Collaborators
Hoya Cooperation Vision Care

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Progressive addition lens designs are unknown to participants, investigators, and outcomes assessors.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: The specified PAL design wearers
Arm Type
Experimental
Arm Description
Subjects who have been already wearing any from specified design type of PAL
Arm Title
The other PAL design wearers
Arm Type
Active Comparator
Arm Description
Subjects who have been already wearing any from the other design type of PAL
Intervention Type
Device
Intervention Name(s)
Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating
Intervention Description
Subjects will be wearing three different PAL designs with different geometries of the optical progression.
Primary Outcome Measure Information:
Title
Evaluate the adaptation to progressive lens designs.
Description
Evaluate the adaptation to progressive lens designs through a "Satisfaction questionnaire" after 1 week of use of each of the 3 progressive addition lenses. The "Satisfaction questionnaire" assesses: visual comfort, visual acuity at far distances, intermediate, and near distances, and visual fields at far distances, intermediate, and near distances. Each is evaluated on a 5-point scale from 5 (very comfortable) to 1 (very uncomfortable).
Time Frame
Entire study duration (approx. 4 weeks)
Secondary Outcome Measure Information:
Title
Evaluate the preference among progressive lens designs.
Description
Evaluate the preference among progressive lens designs through a "Final comparison questionnaire". The survey asks to rank the three pairs of glasses ("The best", "Good", "The worst") with respect to which provides a better distance visual acuity (seeing clear and sharp), wider field of view, and having the least perceived swaying/floating effects. The ranking is conducted for distance, intermediate, and near vision.
Time Frame
Entire study duration (approx. 4 weeks)
Title
Evaluate the fast impression of progressive lens designs.
Description
Evaluate first impression of progressive lens designs through a "First impression questionnaire" after 10-15 minutes of wearing each of the 3 PALs. The "First impression questionnaire" scale is (a) very comfortable, (b) comfortable, (c) adequate, (d) slightly uncomfortable, (e) uncomfortable.
Time Frame
10-15 minutes of wearing time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Spors, Ph.D.
Organizational Affiliation
Western University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western University of Health Sciences
City
Pomona
State/Province
California
ZIP/Postal Code
91766
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Assessment of Three Basic Progressive Lens Designs

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