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

NCT06914505 | Not Yet Recruiting DMC

• 1 other identifier: LYS2024211001
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Visual Field Defects; Visual Field Loss

Keywords

visual field defect; visual restoration therapy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

VRT treatment group

EXPERIMENTAL

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

control group

NO INTERVENTION

Participants will be provided with a pair of appropriate vision aids, however without any visual treatment.

Interventions

visual restoration therapy BEHAVIORAL

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.

Also known as: photostimulation therapy

VRT treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Officials

• Zhen Li, MD. and PHD.

  Ophthalmology Department, Xuanwu Hospital，Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Li, MD. and PHD.

CONTACT

+86 13581646689; zhenli_xwyy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 6, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share