Improving Glare and Visual Comfort for Patients With Visu... | NCT05829135

Studies
Improving Glare and Visual Comfort for Patients With Visual Impairment

NCT05829135

Sponsor

Nova Southeastern University

Status

Withdrawn

Last Update Posted

Jun 19, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Photophobia
Visual Impairment
Low Vision

Interventions

Acuvue Oasys with Transitions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

contact lens no longer available for study

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Jun 16, 2025Actual

Completion Date

Jun 16, 2025Actual

First Submitted Date

Aug 25, 2022

First Submission Date that Met QC Criteria

Apr 12, 2023

First Posted Date

Apr 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2025

Last Update Posted Date

Jun 19, 2025Actual

Name	Class
American Academy of Optometry	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	All participants will be fit with Acuvue Oasys with Transitions.	Device: Acuvue Oasys with Transitions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acuvue Oasys with Transitions	Device	soft contact lenses with darkening technology	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
So Yeon Lee, OD	Nova Southeastern University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nova Southeastern University		Davie	Florida	33332	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020795	Photophobia
D014786	Vision Disorders
D015354	Vision, Low

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided