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

NCT05739539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-06-24

No results posted yet for this study

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.

Conditions

  • Diabetic Vitreous Hemorrhage
  • Tractional Retinal Detachment

Interventions

DIAGNOSTIC_TEST

optical coherence tomography angiography

optical coherence tomography angiography will be done postoperatively in both groups to assess the retinal microvascular changes

DIAGNOSTIC_TEST

spectral domain optical coherence tomography

optical coherence tomography for ganglion cell complex (GCC) measurement and assessment of macular edema or epiretinal membrane formation will be done postoperatively in both groups

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Principal Investigators

  • Ahmed E Faseeh, MSc · KasrAlaini hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2023-12-20
Completion
2024-01-05

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05739539 on ClinicalTrials.gov