Evaluation of Retinal Vascular Density in High Myopia Without Pathological Myopic Maculopathy Using OCTA .

September 11, 2024 updated by: Sara Magdy Mohamed, Sohag University
Study aiming to evaluate Macular Vascular Density in High Myopes without pathological myopic maculopathy in outpatient clinic in Sohag teaching hospital using OCTA .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Design : This is a cross sectional observational study , of about 50 patients attending ophthalmology outpatient clinic at Sohag Teaching Hospital .

Inclusion criteria :

All myopic patients with axial high myopia (-6 spherical refractive error or more) attending the ophthalmology outpatient clinic .

Exclusion criteria :

The exclusion criteria will include :

  • History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
  • Previous intraocular surgery or ocular injury .
  • Any patient with pathological myopic maculopathy (epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy ) .

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

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

Study Contact Backup

  • Name: Islam Awny Ahmed, Ass. Prof
  • Phone Number: 00201006429637

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Recruiting
        • Sohag University

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

Description

Inclusion Criteria wil include :

  • All myopic patients with axial high myopia (-6 spherical refractive error or more) of different age groups .

Exclusion Criteria will include :

  • -History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
  • Previous intraocular surgery or ocular injury .
  • Any patient with pathological myopic maculopathy as epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy .

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Myopes of spherical error -6 and more .
About 50 participants with high myopia will undergo evaluation of their macular vascular density using OCTA and also central macular thickness using OCT.
Other: optical coherence tomography angiography
OCTA will be used to evaluate the macular vascular density and to exclude patients with pathological myopic maculopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome of evaluation of vascular density in high myopes
Time Frame: 6 month

Correlation between macular vascular density in high myopes and their :

Uncorrected visual acuity in diopters . Best corrected visual acuity in diopters . Spherical equivalent refraction that measured through this equivalent (spherical error + 1/2 cylindrical error ) .

Central macular thickness in micrometers .

To see how does ischemia affects vision in high myopes .
6 month

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Study Chair: Adham Salah Mohammed, lecturer, Sohag 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)

September 11, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vascular Density in high Myope

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

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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