Diabetic Retinopathy (DR)NCT07095777
Study on the Recovery of Visual Perceptual Function Dysfunction in Patients With Diabetes
A study testing visual perceptual learning in people with Diabetic Retinopathy (DR) and Visual Perception, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Retinopathy (DR), Visual Perception
- What is being tested?
- visual perceptual learning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 9 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- significant refractive media opacity
- psychiatric disorders, chronic alcoholism and traumatic brain injury
- new-onset vitreous hemorrhage, myopia, strabismus, amblyopia, glaucoma and macular diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
About this study
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
- Being tested
- visual perceptual learning
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual perceptual learningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| visual perceptual learning group | Experimental | Not described Receives: Procedure: visual perceptual learning |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
The Low Vision Quality of Life Questionnaire
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Mar 2023
- Primary completion31 Jul 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lixia Feng, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095777
- Sponsor's protocol ID
- PJ2022-09-48
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations. Participants did not consent to data sharing in the informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Recovery of Visual Perceptual Function Dysfunction in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT07095777
- Acronym / sponsor ID
- PJ2022-09-48
- Conditions
- Diabetic Retinopathy (DR), Visual Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| visual perceptual learning group | Experimental | Procedure: visual perceptual learning |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- significant refractive media opacity
- psychiatric disorders, chronic alcoholism and traumatic brain injury
- new-onset vitreous hemorrhage, myopia, strabismus, amblyopia, glaucoma and macular diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual perceptual learningParticipants 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. | Procedure or surgery | visual perceptual learning group |
Primary outcome
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.
1 secondary outcome
The Low Vision Quality of Life Questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations. Participants did not consent to data sharing in the informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual perceptual learning in people with Diabetic Retinopathy (DR) and Visual Perception, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
contrast sensitivity (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.