Medial Rectus Fenestration vs Recession for PAET

Partially Accommodative Esotropia Clinical Trial

Official title:

Medial Rectus Muscle Fenestration Versus Medial Rectus Recession for Partially Accommodative Esotropia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298929
• Other study ID #: 36264PR427/11/23
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: March 2024
• Source: Mansoura University
• Contact: Ameera G Abdelhameed, MD
• Phone: +201120090000
• Email: amiragamal287[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Esotropia
• Partially Accommodative Esotropia
• Strabismus

Intervention

Procedure:
• medial rectus fenestration
Fenestration technique involves making two splitting incisions by blunt dissection parallel to the muscle fibers on the superior and inferior borders of the muscle, leaving 1 mm of muscle fibers on each edge. The rectangular wide central part is excised from the insertion and between the two splitting incisions to a point back 5-8 mm depending on the angle of the esotropia.
• medial rectus recession
recession is one of the gold standard weakening procedures that involves disinsertion of the muscle and re-suturing to the sclera at a more posterior location to decrease its contractile power.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	Gharbeya

Sponsors (2)

Lead Sponsor	Collaborator
Mansoura University	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular alignment (measured in prism diopters)	The distance and near angles of deviation, with and without glasses, and the angle disparity	6 months postoperative
Secondary	ocular motility	ductions of both eyes (graded on a scale of nine points from -4 to +4)	6 months postoperative