Choroidal and Retinal Thickness Following Strabismus Surgery

• Conditions: Strabismus; Retinal Thickening
• Interventions: Procedure: Strabismus surgery

• Registration Number: NCT04285177
• Lead Sponsor: Tanta University

Brief Summary

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

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 Timeline

• Status Verified: 2020-02
• Study Start: 2020-02-15
• Study First Submitted: 2020-02-23
• Study First Submitted QC: 2020-02-23
• Last Update Submitted: 2020-02-23
• Study First Posted: 2020-02-26
• Last Update Posted: 2020-02-26
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with combined horizontal and oblique muscle surgery	Strabismus surgery	Having combined surgery
Horizontal muscle surgery	Strabismus surgery	Patients suffering from esotropia or exotropia, will have medial/lateral rectus recession/resection
Patients with Inferior Oblique Overaction	Strabismus surgery	Will undergo inferior Oblique Myectomy

Primary Outcome Measures

Name	Time	Method
Choroidal and retinal thickness change after strabismus surgery	preoperative, 1st week, 1st month, and 3 months	Measured by Spectral Domain Optical coherence tomography

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, Gharbeya, Egypt