Choroidal and Retinal Thickness Following Strabismus Surgery

Strabismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04285177
• Other study ID #: TUORU003
• Status: Enrolling by invitation
• Start date: February 15, 2020
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Retinal Thickening
• Strabismus

Intervention

Procedure:
• Strabismus surgery
Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Gharbeya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal and retinal thickness change after strabismus surgery	Measured by Spectral Domain Optical coherence tomography	preoperative, 1st week, 1st month, and 3 months