Assessment of Three Basic Progressive Lens Designs

Presbyopia Clinical Trial

Official title:

Assessment of Three Basic Progressive Lens Designs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05252871
• Other study ID #: P21/IRB/065
• Status: Completed
• Phase: N/A
• Start date: December 9, 2021
• Est. completion date: June 6, 2022

Study information

• Verified date: July 2022
• Source: Western University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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 2? 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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

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.

Locations

Country	Name	City	State
United States	Western University of Health Sciences	Pomona	California

Sponsors (2)

Lead Sponsor	Collaborator
Western University of Health Sciences	Hoya Cooperation Vision Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Entire study duration (approx. 4 weeks)
Secondary	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.	Entire study duration (approx. 4 weeks)
Secondary	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.	10-15 minutes of wearing time.