Improving Glare and Visual Comfort for Patients With Visual Impairment

Not Applicable

Recruiting

• Conditions: Photophobia; Low Vision; Visual Impairment
• Interventions: Device: Acuvue Oasys with Transitions

• Registration Number: NCT05829135
• Lead Sponsor: Nova Southeastern University

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.

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 Timeline

• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Study Start: 2023-05-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-06
• Primary Completion: 2026-05
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Acuvue Oasys with Transitions	All participants will be fit with Acuvue Oasys with Transitions.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Nova Southeastern University; 🇺🇸 Davie, Florida, United States