Optical Coherence Tomography in Retinal Vein Occlusion

March 15, 2025 updated by: Mayar Adel Francis, Assiut University

Optical Coherence Tomography Data As a Prognostic Indicator in Retinal Vein Occlusion

This study aims to evaluate how optical coherence tomography (OCT) can help predict outcomes in patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. The study will use OCT scans to assess changes in the retina and how these changes relate to vision improvement over time.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Objectives Evaluate how OCT data can predict visual outcomes by analyzing retinal changes and macular edema characteristics.

Assess the correlation between baseline OCT biomarkers and visual acuity improvements over time.

Study Design Type: Cross-sectional study.

Setting: Conducted at several eye care centers in Egypt.

Participants Inclusion Criteria: Adults with branch or central RVO, macular edema confirmed by OCT, and no prior RVO in the affected eye.

Exclusion Criteria: Other retinal diseases, recent intraocular surgery, or significant media opacities.

Procedures Informed Consent and History Taking.

Ophthalmologic Examination: Includes BCVA, IOP, slit-lamp biomicroscopy, and fundus examination.

OCT Imaging: Using NIDEK RS-330 Retina scan duo 2 (SD-OCT) to assess macular changes.

OCT Image Evaluation: Classification of macular edema types and assessment of biomarkers like subretinal fluid and cystoid changes.

Study Type

Observational

Enrollment (Estimated)

30

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. Adults aged 18 or older with branch or central retinal vein occlusion. Patients must have macular edema confirmed by OCT and no previous RVO in the affected eye.

Description

Inclusion Criteria:

  • Adults aged 18 years or older.

Patients diagnosed with branch or central retinal vein occlusion.

Patients with macular edema confirmed by OCT due to vein occlusion.

Patients with no prior history of RVO in the affected eye.

Exclusion Criteria:

  • Presence of other retinal diseases that could affect OCT interpretation (e.g., diabetic retinopathy, age-related macular degeneration).

History of intraocular surgery within the last three months.

Presence of significant media opacities (e.g., dense cataract, vitreous hemorrhage) that interfere with OCT 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

Cohorts and Interventions

Group / Cohort
Adults with branch or central RVO, macular edema confirmed by OCT, and no prior RVO in the affected

Adults aged 18 years or older.

Patients diagnosed with branch or central retinal vein occlusion.

Patients with macular edema confirmed by OCT due to vein occlusion.

Patients with no prior history of RVO in the affected eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in OCT biomarkers and visual acuity post-treatment.
Time Frame: 6 months
Correlation between baseline OCT biomarkers and visual acuity at presentation after 1, 3, and 6 months post-treatment.
6 months

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)

May 1, 2025

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 15, 2025

First Submitted That Met QC Criteria

March 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 15, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCT in retinal vein occlusion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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