Study on the Recovery of Visual Perceptual Function Dysfunction in Patients With Diabetes

NCT ID: NCT07095777

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-08-09

Brief Summary

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Investigators aim to investigate the effectiveness of visual perceptual learning on visual perceptual function in participants with diabetic retinopathy and to provide novel therapeutic insights for visual functional rehabilitation in diabetic retinopathy.

Detailed Description

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Conditions

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Diabetic Retinopathy (DR) Visual Perception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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visual perceptual learning group

Group Type EXPERIMENTAL

visual perceptual learning

Intervention Type PROCEDURE

Participants in the VPL group performed 40 minutes of daily monocular training at home for three months, with follow-up evaluations conducted at 1 month and 3 months after training initiation.

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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visual perceptual learning

Participants in the VPL group performed 40 minutes of daily monocular training at home for three months, with follow-up evaluations conducted at 1 month and 3 months after training initiation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* moderate to severe non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy(PDR) prior to treatment(17)
* prior pan retinal laser photocoagulation (PRP) at least 4 weeks before enrollment or vitreoretinal surgery at least 8 weeks before enrollment
* stable clinical condition
* best-corrected visual acuity (BCVA) \> 1.0 logMAR (equivalent to a Snellen visual acuity of \< 20/200)
* clear refractive media
* age ≤ 65 years
* ability to comprehend the examination and training procedures

Exclusion Criteria

* significant refractive media opacity
* psychiatric disorders, chronic alcoholism and traumatic brain injury
* new-onset vitreous hemorrhage, myopia, strabismus, amblyopia, glaucoma and macular diseases.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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Lixia Feng

Chief physician, Doctoral supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PJ2022-09-48

Identifier Type: -

Identifier Source: org_study_id

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