Improving Glare and Visual Comfort for Patients With Visual Impairment

November 7, 2023 updated by: So Yeon Lee, Nova Southeastern University

Managing Visual Comfort and Function in Patients With Low Vision Using Acuvue Oasys

To assess the use of contact lenses with transitions technology to improve glare, light sensitivity and overall visual comfort in patients with visual impairment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology can adapt to the amount of visible light in the environment, darkening the lenses in bright sunlight, and returning to regular tint in normal or dim environment.

Purpose of this study is to assess whether individuals with visual impairment may benefit from these lenses to minimize glare, light sensitivity symptoms and improve the overall visual comfort.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: So Yeon Lee, OD
  • Phone Number: 9542624200
  • Email: slee@nova.edu

Study Contact Backup

  • Name: Samantha McIntosh, OD
  • Phone Number: 9542624200
  • Email: sm1554@nova.edu

Study Locations

  • United States
    • Florida
      • Davie, Florida, United States, 33332
        • Recruiting
        • Nova Southeastern University
        • Contact:
        • Contact:
          • So Yeon Lee, OD
          • Phone Number: 954-262-4200
          • Email: slee@nova.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability to give informed consent
  • Able to speak and read English
  • Experience glare and light sensitivity that impacts patient's daily living activities
  • Have confirmed diagnosis of ocular condition including but not limited to Stargardt's, Cone dystrophy, Cone-rod dystrophy, Albinism, Retinitis Pigmentosa and Achromatopsia.
  • Willing and able to wear the contact lenses as instructed

Exclusion Criteria:

  • Are pregnant, nursing or planning to become pregnant during the course of the study
  • Have current/recent ocular infection, inflammation, surgery in the past 3 months that contraindicates contact lens wear

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
All participants will be fit with Acuvue Oasys with Transitions.
Device: Acuvue Oasys with Transitions
soft contact lenses with darkening technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glare test
Time Frame: Measure change from baseline at the 6 week follow-up visit
Measure visual acuity and contrast sensitivity with or without illumination source
Measure change from baseline at the 6 week follow-up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Activities Questionnaire on Glare and Light sensitivity visual functions
Time Frame: Measure change from baseline at the 6 week follow-up visit
Patient will rate 7 questions on scale ranges from 1-5, higher score indicates more symptoms related to glare and light sensitivity during daily living tasks. Max value 35
Measure change from baseline at the 6 week follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Collaborators

American Academy of Optometry

Investigators

  • Study Chair: So Yeon Lee, OD, Nova Southeastern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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