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

NCT07095777 | Completed DMC

• 1 other identifier: PJ2022-09-48
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy (DR); Visual Perception

Outcome Measures

Primary Outcomes (1)

• contrast sensitivity

  The contrast sensitivity measurements include grating acuity, first-order motion stimulus perception sensitivity, second-order stationary stimulus perception sensitivity and second-order motion stimulus perception sensitivity, which represent the reciprocal of the contrast threshold.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (1)

• The Low Vision Quality of Life Questionnaire

  From enrollment to the end of treatment at 12 weeks

Other Outcomes (1)

• The Hospital Anxiety and Depression Scale

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

visual perceptual learning group

EXPERIMENTAL

Procedure: visual perceptual learning

control group

NO INTERVENTION

Interventions

visual perceptual learning 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.

visual perceptual learning group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Doctoral supervisor

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 31, 2025
• Study Start: March 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 9, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)