Assessment of Retinal Vascular Changes With and Without ILM Peeling in Diabetic Vitrectomy Using … (NCT05739539) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Retinal Vascular Changes With and Without ILM Peeling in Diabetic Vitrectomy Using OCT-A.
Egypt36 participantsStarted 2022-04-01
Plain-language summary
Tractional retinal detachment (TRD) that involves the macula and non-clearing vitreous hemorrhage are the main causes of permanent vision loss in patients with diabetic retinopathy and requires prompt surgical intervention.
Macular peeling is a surgical technique used in many retinal diseases including diabetic retinal detachment.
Our purpose is to determine whether retinal microcirculatory changes occur after anatomically successful diabetic vitrectomy, and whether changes in blood flow vary if ILM peeling was done and whether changes in macular perfusion affect the final visual outcome.
The aim of this study is to non-invasively evaluate, with optical coherence tomography angiography (OCT-A), the anatomical changes of deep and superficial vascular density in the macula with and without macular peeling in diabetic vitrectomy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age above 18 years old of both sexes.
* Patients having diabetic tractional retinal detachement threatening the macula (traction over posterior pole with attached fovea).
* Combined tractional-rhegmatogenous retinal detachement with attached macula.
* Diabetic persistent fibrovascular proliferation not responding to panretinal photocoagulation.
* Non clearing diabetic vitreous hemorrhage, subhyaloid hemorrhage.
Exclusion Criteria:
* Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
* Subject has uncontrolled neovascular glaucoma (intraocular pressure \> 30 mmHg despite medical/surgical treatment) in the study eye.
* Previous history of trauma in the study eye.
* Previous history of Anti-VEGF injection.
* Tractional macular detachment.
* Coexisting macular hole.
* Cases with previous arterial or venous occlusions.
* Coexisting posterior segment inflammation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare the superficial and deep vascular densities using OCT-A with and without ILM peeling in diabetic vitrectomy patients.
Timeframe: 18 months total study duration , 9 months follow up
2
Compare the foveal avascular zone using OCT-A between both groups.
Timeframe: 18 months total study duration , 9 months follow up