Medial Rectus Fenestration vs Recession for PAET

NCT ID: NCT06298929

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-10-15

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)

Conditions

Partially Accommodative Esotropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

patients with PAET who will receive unilateral or bilateral MR fenestration

Group Type: ACTIVE_COMPARATOR

medial rectus fenestration

Intervention Type: PROCEDURE

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.

Group 2

patients with PAET who will receive unilateral or bilateral MR recession

Group Type: ACTIVE_COMPARATOR

medial rectus recession

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: collaborator

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ameera Gamal Abdelhameed

assistant professor of ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ameera G Abdelhameed, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of ophthalmology

Locations

Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ameera G Abdelhameed, MD

Role: CONTACT

amiragamal287@mans.edu.eg

+201120090000

Facility Contacts

Heba M Shafeik, MD

Role: primary

heba.saeid@med.tanta.edu.eg

+201227440829

Other Identifiers

36264PR427/11/23

Identifier Type: -

Identifier Source: org_study_id