Improving Glare and Visual Comfort for Patients With Visual Impairment

Sponsor

Nova Southeastern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05829135

Collaborator

American Academy of Optometry (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Photophobia Visual Impairment Low Vision	Device: Acuvue Oasys with Transitions	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Glare test [Measure change from baseline at the 6 week follow-up visit]
Measure visual acuity and contrast sensitivity with or without illumination source

Secondary Outcome Measures

Visual Activities Questionnaire on Glare and Light sensitivity visual functions [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nova Southeastern University	Davie	Florida	United States	33332

Sponsors and Collaborators

Nova Southeastern University
American Academy of Optometry

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

So Yeon Lee, Assistant professor, Nova Southeastern University

ClinicalTrials.gov Identifier:

NCT05829135

Other Study ID Numbers:

2020-128

First Posted:

Apr 25, 2023

Last Update Posted:

Apr 25, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Vision Disorders

Vision, Low

Photophobia

Study Results

No Results Posted as of Apr 25, 2023