Medial Rectus Fenestration vs Recession for PAET

Not Applicable

Recruiting

• Conditions: Partially Accommodative Esotropia
• Interventions: Procedure: medial rectus fenestration; Procedure: medial rectus recession

• Registration Number: NCT06298929
• Lead Sponsor: Mansoura University

Brief Summary

This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET.

All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration.

Detailed Description

Inclusion criteria The study will include patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is \> 15PD.

Exclusion criteria:

1. Patients with convergence excess esotropia, defined as a near deviation with glasses exceeding that for distance by 15 PD or more.

2. Patients with paralytic or restrictive strabismus.

3. Patients with previous strabismus surgery

4. Patients with neurologic, ocular, or developmental disorders or follow-up less than 6 months

All patients will receive complete ophthalmic and orthoptic assessment including:

i) A full ophthalmological assessment including history taking, measurement of uncorrected and best-corrected visual acuity, cycloplegic refraction, anterior segment examination, as well as a dilated fundus examination.

ii) Measurement of the deviation at distance (6 m) and near (33 cm). iii) Assessment of ductions and versions in all cardinal directions of gaze

Patients will be randomly allocated using a random table to one of two groups:

1. Group 1: Unilateral or bilateral conventional MR recession. Augmented formula will be used to decide the Surgical dosage using the standard tables (3)

2. Group 2: unilateral or bilateral MR fenestration All surgeries will be performed by one experienced surgeon (H.SH)

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2024-02-25
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-07
• Last Update Posted: 2024-03-07
• Primary Completion: 2024-09-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is > 15PD.

Exclusion Criteria

1. convergence excess esotropia.
2. paralytic or restrictive strabismus.
3. previous strabismus surgery
4. neurologic, ocular, or developmental disorders or follow-up less than 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	medial rectus fenestration	patients with PAET who will receive unilateral or bilateral MR fenestration
Group 2	medial rectus recession	patients with PAET who will receive unilateral or bilateral MR recession

Primary Outcome Measures

Name	Time	Method
Ocular alignment (measured in prism diopters)	6 months postoperative	The distance and near angles of deviation, with and without glasses, and the angle disparity

Secondary Outcome Measures

Name	Time	Method
ocular motility	6 months postoperative	ductions of both eyes (graded on a scale of nine points from -4 to +4)

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Gharbeya, Egypt