OCT and OCT-A Afer Diabetic Vitrectomy in PDR

July 4, 2023 updated by: Omar Abdelkarem Hasan, Assiut University

OCT and OCT Angiography After Diabetic Vitrectomy With or Without Internal Limiting Membrane Peeling for Patients With PDR

Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR )

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with complicated proliferative diabetic retinopathy underwent pars plana vitrectomy

Description

Inclusion Criteria:

  • Cases with complicated PDR as persistant vitreous hemorrhage or tractional retinal detachment involving or threatening the macula underwent PPV with or without ILM peeling

Exclusion Criteria:

  • eyes with media opacity after PPV not allowing imaging of the macula

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT and OCT angiography to assess the macular thickness , outline and vascularity
Time Frame: 3 months after surgery
Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR ) .
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

July 4, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • oct after diabetic vitrectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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