Assessment of Three Basic Progressive Lens Designs

NCT05252871 | Completed Results DMC FDA Device

• 1 other identifier: P21/IRB/065
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluate the Immediate Preference Among Progressive Lens Designs.

  Directly after receiving the lenses (approx. 15 minutes)

• Evaluate the Preference of Progressive Lens Designs.

  Entire study duration (approx. 4 weeks)

Study Arms (2)

Experimental: The specified PAL design wearers

EXPERIMENTAL

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

The other PAL design wearers

ACTIVE COMPARATOR

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

Interventions

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

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

Experimental: The specified PAL design wearers; The other PAL design wearers

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University of Health Sciences: lead
• Hoya Vision Care: collaborator

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91766, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

There are no limitations to be reported. The study went as planned.

Results Point of Contact

• Title: Frank Spors
• Organization: Western University of Health Sciences

fspors@westernu.edu

9097063883

Study Officials

• Frank Spors, Ph.D.

  Western University of Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Progressive addition lens designs are unknown to participants, investigators, and outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 23, 2022
• Study Start: December 9, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-07

Locations

US (1)