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Recruiting NCT05739539

Assessment of Retinal Vascular Changes With and Without ILM Peeling in Diabetic Vitrectomy Using OCT-A.

Conditions: Diabetic Vitreous Hemorrhage, Tractional Retinal Detachment

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 36
Sponsor: Kasr El Aini Hospital

Location: Egypt

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05739539). StuddyBuddy aggregates publicly available trial information.