Choroidal and Retinal Thickness Following Strabismus Surgery

February 23, 2020 updated by: Heba Shafik, Tanta University

Effect of Strabismus Surgery on Macular and Subfoveal Choroidal Thickness Assessed by Spectral Domain Optical Coherence Tomography

Prospective study, conducted at Tanta University Ophthalmology Department Measurement of macular and choroidal thickness before and after strabismus surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study and will be conducted in Tanta University hospital

  • Duration: February 2020 till May 2020 and may be extended
  • The study will include 30 patients who suffer from esotropia or exotropia, inferior oblique (IO) over-action with or without any other type of horizontal deviation

Pre-operative measurement of the macular and choroidal thickness by Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT).

Post-operative measurement: First day, first week, one month then 3 months.

Study Type

Observational

Enrollment (Anticipated)

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
    • Gharbeya
      • Tanta, Gharbeya, Egypt, 31111
        • Tanta University 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

7 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All individual with strabismus fulfilling the inclusion criteria

Description

Inclusion Criteria:

  • No prior history of ocular surgery or trauma
  • Normal ocular examination findings
  • No medical or family history of retinal disease, glaucoma or diabetes mellitus.

Exclusion Criteria:

  • Patients with orbital and/or craniofacial abnormalities
  • Patients with sensory or restrictive strabismus or neurological disease
  • Preoperative retinal or macular pathology
  • Patient who is unable to cooperate to do OCT scanning

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
Intervention / Treatment
Horizontal muscle surgery
Patients suffering from esotropia or exotropia, will have medial/lateral rectus recession/resection
Procedure: Strabismus surgery
Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy
Patients with Inferior Oblique Overaction
Will undergo inferior Oblique Myectomy
Procedure: Strabismus surgery
Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy
Patients with combined horizontal and oblique muscle surgery
Having combined surgery
Procedure: Strabismus surgery
Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choroidal and retinal thickness change after strabismus surgery
Time Frame: preoperative, 1st week, 1st month, and 3 months
Measured by Spectral Domain Optical coherence tomography
preoperative, 1st week, 1st month, and 3 months

Collaborators and Investigators

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

Sponsor

Tanta University

Investigators

  • Principal Investigator: Sharif Y El Emam, MD, Tanta 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 (Actual)

February 15, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 23, 2020

First Submitted That Met QC Criteria

February 23, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 23, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUORU003

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

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.

Clinical Trials on Strabismus

Clinical Trials on Strabismus surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe