Medial Rectus Fenestration vs Recession for PAET

Mansoura University

Status: Enrolling

Conditions: Partially Accommodative Esotropia

Treatments: Procedure: medial rectus fenestration; Procedure: medial rectus recession

Study type: Interventional

Funder types: Other

Identifiers

NCT06298929

36264PR427/11/23

Details and patient eligibility

About

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.

Full 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)

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group 1

Active Comparator group

Description:

patients with PAET who will receive unilateral or bilateral MR fenestration

Treatment:

Procedure: medial rectus fenestration

Group 2

Active Comparator group

Description:

patients with PAET who will receive unilateral or bilateral MR recession

Treatment:

Procedure: medial rectus recession