Study on the Effectiveness and Safety of VRT in Patients With Visual Field Defects

Study on the Effectiveness and Safety of Visual Restoration Therapy in the Active Rehabilitation of Patients With Visual Field Defects

The goal of this clinical trial is to learn if visual restoration therapy (VRT) (a type of treatment that aims to improve vision) works to the visual rehabilitation of patients with visual field defects. It will also learn about the safety of VRT. The main questions it aims to answer are:

• Can visual reconstruction therapy help expand the visual field in patients with visual field defects?
• What medical problems do patients with visual field defects experience during the procedure of VRT? Researchers will look at how patients with visual field defects who use a visual aid in combination with VRT and those who use a visual aid only, compare the visual field expansion at three months to see how well visual reconstruction therapy works.

Participants will:

• will undergo a specialized visual function assessment and be provided with a pair of appropriate vision aids.
• Visit the clinic at one month and three months after enrolment for review of visual function and completion of a Chinese-version Low Vision Quality of Life (CLVQOL) questionnaire.
• Participants receiving VRT will additionally undergo 30 minutes of VRT three times per week for 3 months.
• Keep a diary for their symptoms and severity and frequency of occurrence during treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Visual Field Loss; Visual Field Defects
• Intervention / Treatment: Behavioral: visual restoration therapy

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen Li, MD. and PHD.; Phone Number: +86 13581646689; Email: zhenli_xwyy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants with a clear diagnosis of visual field defects.
2. Participants were between 18 and 80 years of age (including borderline values);
3. Participants have been treated for their primary disease and conditions are stable;
4. Participants are not at significant risk of vision loss in the last three months;
5. Participants do not have planned intraocular surgery during the trial period；
6. Participants can understand the trial protocol and sign informed consent.

Exclusion Criteria:

1. Participants diagnosed as blindness;
2. Participants with a previous history of seizures or other psychiatric disorders;
3. Participants with cognitive impairments;
4. Participant's attention span is less than 30 minutes;
5. Participants had conditions such as significant ptosis or severe dry eye;
6. Participants who were in poor general health or who could not cooperate in completing the study protocol for some reasons such as transport.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VRT treatment group; The participants will be provided with a pair of appropriate vision aids and will undergo 3 times 30-minute visual restoration therapy (VRT) training per week for three months.	Behavioral: visual restoration therapy; In this study, we used a reversing checkerboard pattern as a stimulus and acted on the relatively dark spots area of the patient's visual field.; Other Names: photostimulation therapy
No Intervention: control group; Participants will be provided with a pair of appropriate vision aids, however without any visual treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual field mean deviation (MD) value	using the Humphrey Field Analyzer 30-2 test to obtain MD values	A total of 3 examinations were performed during the trial: before treatment, after 1 month of treatment, and after 3 months of treatment.

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Zhen Li, MD. and PHD., Ophthalmology Department, Xuanwu Hospital，Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: March 30, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: visual field defect; visual restoration therapy
• Other Study ID Numbers: LYS2024211001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No