Medial Rectus Fenestration vs Recession for PAET

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

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.

Study Overview

• Status: Recruiting
• Conditions: Partially Accommodative Esotropia
• Intervention / Treatment: Procedure: medial rectus fenestration; Procedure: medial rectus recession

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)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ameera G Abdelhameed, MD; Phone Number: +201120090000; Email: amiragamal287@mans.edu.eg

Study Locations

• Egypt
  • Gharbeya
    • Tanta, Gharbeya, Egypt
      • Recruiting
      • Tanta university
      • Contact: Heba M Shafeik, MD; Phone Number: +201227440829; Email: heba.saeid@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; patients with PAET who will receive unilateral or bilateral MR fenestration	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.
Active Comparator: Group 2; patients with PAET who will receive unilateral or bilateral MR recession	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ocular motility	ductions of both eyes (graded on a scale of nine points from -4 to +4)	6 months postoperative

Collaborators and Investigators

• Sponsor: Mansoura University
• Collaborators: Tanta University
• Investigators: Principal Investigator: Ameera G Abdelhameed, MD, Assistant professor of ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): October 15, 2024

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: esotropia; hyperopia; recession; fenestration; accommodative
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Esotropia
• Other Study ID Numbers: 36264PR427/11/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No