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Completed

NCT Number: NCT07095777

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

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.

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Key information

Conditions

Diabetic Retinopathy (DR) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases Visual Perception

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. contrast sensitivity

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

Secondary outcomes

  1. The Low Vision Quality of Life Questionnaire

    Time frame: From enrollment to the end of treatment at 12 weeks

    This instrument has demonstrated high reliability and validity, and is sensitive to changes in visual function among individuals with vision loss. The minimum value is 25 and the maximum value is 125. Higher scores indicate better quality of life.

Other outcomes

  1. The Hospital Anxiety and Depression Scale

    Time frame: From enrollment to the end of treatment at 12 weeks

    The scale aims to measure anxiety and depression levels in hospital patients with high reliability and validity. The Hospital Anxiety and Depression Scale (HADS) provides separate scores for anxiety (HADS-A) and depression (HADS-D), each ranging from 0 to 21. A lower score indicates a lesser degree of anxiety and depression.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2025
Registry last updated
Jul 31, 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.

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