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

NCT05739539 | Completed

• 1 other identifier: 1442022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Compare the superficial and deep vascular densities using OCT-A with and without ILM peeling in diabetic vitrectomy patients.

  Compare the superficial and deep vascular densities in percentage compared to normative database using OCT-A (Optovue) with and without ILM peeling in diabetic vitrectomy patients.

  18 months total study duration , 9 months follow up

• Compare the foveal avascular zone using OCT-A between both groups.

  Compare the foveal avascular zone measured in micrometer using OCT-A between both groups.

  18 months total study duration , 9 months follow up

Secondary Outcomes (4)

• Compare the best corrected visual acuity in both groups

  18 months total study duration , 9 months follow up

• Compare OCT ganglion cell complex (GCC) changes in both groups.

  18 months total study duration , 9 months follow up

• Compare incidence of epiretinal membrane formation in both groups.

  18 months total study duration , 9 months follow up

• Compare incidence of macular edema in both groups.

  18 months total study duration , 9 months follow up

Study Arms (2)

pars plana vitrectomy with ILM peeling

ACTIVE COMPARATOR

Diabetic patients who fulfill the inclusion critera and will undergo pars plana vitrectomy and ILM peeling

Diagnostic Test: optical coherence tomography angiography; Diagnostic Test: spectral domain optical coherence tomography

pars plana vitrectomy without ILM peeling

ACTIVE COMPARATOR

Diabetic patients who fulfill the inclusion critera and will undergo pars plana vitrectomy without ILM peeling

Diagnostic Test: optical coherence tomography angiography; Diagnostic Test: spectral domain optical coherence tomography

Interventions

optical coherence tomography angiography DIAGNOSTIC_TEST

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

pars plana vitrectomy with ILM peeling; pars plana vitrectomy without ILM peeling

spectral domain optical coherence tomography DIAGNOSTIC_TEST

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

pars plana vitrectomy with ILM peeling; pars plana vitrectomy without ILM peeling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

KasrAlaini hospital

Cairo, Egypt

Location

Study Officials

• Ahmed E Faseeh, MSc

  KasrAlaini hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Ophthalmology

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 22, 2023
• Study Start: April 1, 2022
• Primary Completion: December 20, 2023
• Study Completion: January 5, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)