Retinal Microvasculature Before and After Silicone Oil by OCTA

March 13, 2023 updated by: Hebatalla Makled, Kasr El Aini Hospital

Evaluation of Retinal Microvasculature Before and After Silicone Oil Removal by Optical Coherence Tomography Angiography

Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

The study includes 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

Study Type

Observational

Enrollment (Actual)

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 Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Cairo University teaching hospital

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

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Prospective observational case series of patients before and after silicone oil removal

Description

Inclusion Criteria:

  • 30 eyes of 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

Exclusion Criteria:

  • Proliferative diabetic retinopathy, recurrent detachment or macular hole
  • Patients with chorioretinal degenerations involving the macula
  • Secondary complications as cataract, silicone oil emulsification, or secondary glaucoma
  • Media opacity hindering proper imaging

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
Macular and optic nerve head vascular density
Time Frame: one year
Using OCTA to assess vascular density changes of the macula and optic nerve head before and after silicone oil removal
one year
Retinal sensitivity by microperimetry
Time Frame: one year
Using microperimetry to assess the retinal sensitivity changes before and after silicone oil removal
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal vascular density and best corrected visual acuity
Time Frame: one year
Correlate the change in the retinal vascular density with best corrected visual acuity
one year
Optic nerve head vascular density and best corrected visual acuity
Time Frame: one year
Correlate the change in the optic nerve head vascular density with best corrected visual acuity
one year
Retinal sensitivity and best corrected visual acuity
Time Frame: one year
Correlate the change in the retinal sensitivity with best corrected visual acuity
one year

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: Hebatalla S. Makled, MD, Kasr El Aini Hospital
  • Principal Investigator: Ghada A. Nassar, MD, Kasr El Aini Hospital
  • Principal Investigator: Maha M. Youssef, MD, Kasr El Aini Hospital
  • Principal Investigator: Lameece M. Hassan, MD, Kasr El Aini Hospital

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 (Actual)

July 12, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

June 5, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6-1-2021-1

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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