Improving Glare and Visual Comfort for Patients With Visual Impairment

Visual Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05829135
• Other study ID #: 2020-128
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: Nova Southeastern University
• Contact: So Yeon Lee, OD
• Phone: 9542624200
• Email: slee[@]nova.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Vision
• Photophobia
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Device:
• Acuvue Oasys with Transitions
soft contact lenses with darkening technology

Locations

Country	Name	City	State
United States	Nova Southeastern University	Davie	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	American Academy of Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glare test	Measure visual acuity and contrast sensitivity with or without illumination source	Measure change from baseline at the 6 week follow-up visit
Secondary	Visual Activities Questionnaire on Glare and Light sensitivity visual functions	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