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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05829135
Other study ID # 2020-128
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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