Clinical trial NCT06914505: Study on the Effectiveness and Safety of VRT in Patients With Visual Field Defects
Official title: Study on the Effectiveness and Safety of Visual Restoration Therapy in the Active Rehabilitation of Patients With Visual Field Defects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Visual Field Defects
Visual Field Loss
Keywords: visual field defect
visual restoration therapy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: visual field mean deviation (MD) value
timeFrame: A total of 3 examinations were performed during the trial: before treatment, after 1 month of treatment, and after 3 months of treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ophthalmology Department, Xuanwu Hospital，Capital Medical University
name: Zhen Li, MD. and PHD.
role: PRINCIPAL_INVESTIGATOR
References: