Improving Glare and Visual Comfort for Patients With Visual Impairment

NCT ID: NCT05829135

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-06-16

Brief Summary

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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

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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.

Conditions

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Photophobia Visual Impairment Low Vision

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

All participants will be fit with Acuvue Oasys with Transitions.

Group Type EXPERIMENTAL

Acuvue Oasys with Transitions

Intervention Type DEVICE

soft contact lenses with darkening technology

Interventions

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Acuvue Oasys with Transitions

soft contact lenses with darkening technology

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Academy of Optometry

OTHER

Sponsor Role collaborator

Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

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So Yeon Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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So Yeon Lee, OD

Role: STUDY_CHAIR

Nova Southeastern University

Locations

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Nova Southeastern University

Davie, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2020-128

Identifier Type: -

Identifier Source: org_study_id

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