Clinical trial NCT06298929: Medial Rectus Fenestration vs Recession for PAET
Official title: Medial Rectus Muscle Fenestration Versus Medial Rectus Recession for Partially Accommodative Esotropia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Partially Accommodative Esotropia
Keywords: esotropia
accommodative
hyperopia
recession
fenestration
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2024-03-07
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Ocular alignment (measured in prism diopters)
timeFrame: 6 months postoperative
Secondary outcomes:
measure: ocular motility
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbeya
Study officials:
affiliation: Assistant professor of ophthalmology
name: Ameera G Abdelhameed, MD
role: PRINCIPAL_INVESTIGATOR
References: