Early surgery may beat laser for diabetic eye damage
NCT ID NCT07586787
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two treatments for early proliferative diabetic retinopathy, a complication of diabetes that causes abnormal blood vessels in the eye. One group gets early microincision vitrectomy surgery plus laser, while the other gets standard laser therapy alone. The goal is to see which approach better shrinks these abnormal vessels and improves vision over 12 months. About 100 adults with type 2 diabetes are being enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Microincision vitrectomy surgery (MIVS) and panretinal photocoagulation (laser therapy)
- What this could lead to
- If early surgery works better than laser, it could become a new standard treatment to control diabetic eye disease and prevent vision loss.
- What could go wrong
- This is a small, early-stage trial with only 100 participants. Surgery carries risks like infection or bleeding, and the results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older. Diagnosis of type 2 diabetes mellitus. Presence of early proliferative diabetic retinopathy with active neovascularization, or mild vitreous hemorrhage or preretinal hemorrhage that does not interfere with evaluation of neovascularization. Relatively clear optical media, good pupillary dilation, and sufficient cooperation for panretinal photocoagulation and retinal imaging. Ability and willingness to provide written informed consent. If both eyes are eligible, the eye with worse vision will be included. Exclusion Criteria: * Prior panretinal photocoagulation, macular photocoagulation, or vitrectomy in the study eye. Retinal traction or retinal detachment. Optic neuropathy. Macular edema caused by reasons other than diabetes. Coexisting ocular disease that may decrease visual acuity during the study. Substantial cataract likely to decrease visual acuity by more than three lines. Major ocular surgery within the past 4 months or planned intraocular surgery within the next 6 months. YAG capsulotomy within the past 2 months. Any intravitreal injection within the past 3 months. Aphakia. Severe external ocular infection. Uncontrolled glaucoma. Significant renal disease requiring dialysis or kidney transplantation. Unstable glycemic control. Blood pressure greater than 180/110 mmHg. History of transient ischemic attack, stroke, myocardial infarction, acute congestive heart failure, or other acute cardiac event requiring hospitalization within the past 4 months. Pregnant, lactating, or intending to become pregnant during the study period. Participation in another clinical trial. Unwilling or unable to provide informed consent, undergo randomization, or return for scheduled visits.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan Province People's Hospital
COMPLETEDZhengzhou, Henan, China
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Jiangsu Provincial People's Hospital
COMPLETEDNanjing, Jiangsu, China
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Nanjing Medical University affiliated Eye Hospital
COMPLETEDNanjing, Jiangsu, China
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Peking University People's Hospital
COMPLETEDBeijing, Beijing Municipality, China
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The First Affiliated Hospital of Dalian Medical University
COMPLETEDDalian, Liaoning, China
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Xiamen Eye Center of Xiamen University
RECRUITINGXiamen, Fujian, 361000, China
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