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Improving Glare and Visual Comfort for Patients With Visual Impairment

Primary Purpose

Photophobia, Visual Impairment, Low Vision

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acuvue Oasys with Transitions

About this trial

This is an interventional treatment trial for Photophobia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nova Southeastern UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

All participants will be fit with Acuvue Oasys with Transitions.

Outcomes

Primary Outcome Measures

Glare test

Measure visual acuity and contrast sensitivity with or without illumination source

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05829135

First Posted

August 25, 2022

Last Updated

June 19, 2023

Sponsor

Nova Southeastern University

Collaborators

American Academy of Optometry

1. Study Identification

Unique Protocol Identification Number

NCT05829135

Brief Title

Improving Glare and Visual Comfort for Patients With Visual Impairment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2023 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nova Southeastern University

Collaborators

American Academy of Optometry

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Photophobia, Visual Impairment, Low Vision

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

All participants will be fit with Acuvue Oasys with Transitions.

Intervention Type

Device

Intervention Name(s)

Acuvue Oasys with Transitions

Intervention Description

soft contact lenses with darkening technology

Primary Outcome Measure Information:

Title

Glare test

Description

Measure visual acuity and contrast sensitivity with or without illumination source

Time Frame

Measure change from baseline at the 6 week follow-up visit

Secondary Outcome Measure Information:

Title

Visual Activities Questionnaire on Glare and Light sensitivity visual functions

Description

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

Time Frame

Measure change from baseline at the 6 week follow-up visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

So Yeon Lee, OD

Phone

9542624200

slee@nova.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Samantha McIntosh, OD

Phone

9542624200

sm1554@nova.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

So Yeon Lee, OD

Organizational Affiliation

Nova Southeastern University

Official's Role

Study Chair

Facility Information:

Facility Name

Nova Southeastern University

City

Davie

State/Province

Florida

ZIP/Postal Code

33332

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

So Yeon Lee, OD

Phone

954-262-4200

slee@nova.edu

First Name & Middle Initial & Last Name & Degree

Samantha McIntosh, OD

Phone

9542624200

sm1554@nova.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Improving Glare and Visual Comfort for Patients With Visual Impairment

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