An interventional study of medial rectus fenestration and medial rectus recession in Partially Accommodative Esotropia, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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.
Inclusion criteria The study will include patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is > 15PD.
Exclusion criteria:
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:
36 studies on the registry are indexed under Esotropia; 11 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 23 interventional studies indexed under Esotropia.
Browse Esotropia studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
patients with PAET who will receive unilateral or bilateral MR fenestration
Procedure: medial rectus fenestration
patients with PAET who will receive unilateral or bilateral MR recession
Procedure: medial rectus recession
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.
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.
Ocular alignment (measured in prism diopters)
The distance and near angles of deviation, with and without glasses, and the angle disparity
Time frame: 6 months postoperative
ocular motility
ductions of both eyes (graded on a scale of nine points from -4 to +4)
Time frame: 6 months postoperative
Plan to share: No
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