Study on the Effectiveness and Safety of VRT in 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.

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Key information

Conditions

Visual Field Defects Visual Field Loss

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Other names: photostimulation therapy

Primary outcomes

visual field mean deviation (MD) value

Time frame: A total of 3 examinations were performed during the trial: before treatment, after 1 month of treatment, and after 3 months of treatment.

using the Humphrey Field Analyzer 30-2 test to obtain MD values

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Li, MD. and PHD.

CONTACT

[email protected]

+86 13581646689

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Apr 6, 2025
Registry last updated: Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed