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Medial Rectus Fenestration vs Recession for PAET

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06298929
Enrollment
60
Registered
2024-03-07
Start date
2023-11-15
Completion date
2024-10-15
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partially Accommodative Esotropia

Keywords

esotropia, accommodative, hyperopia, recession, fenestration

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)

Interventions

PROCEDUREmedial 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.

PROCEDUREmedial 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.

Sponsors

Mansoura University
Lead SponsorOTHER
Tanta University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ocular alignment (measured in prism diopters)6 months postoperativeThe distance and near angles of deviation, with and without glasses, and the angle disparity

Secondary

MeasureTime frameDescription
ocular motility6 months postoperativeductions of both eyes (graded on a scale of nine points from -4 to +4)

Countries

Egypt

Contacts

Primary ContactAmeera G Abdelhameed, MD
amiragamal287@mans.edu.eg+201120090000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026