Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298929
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-25
Brief Title:
Medial Rectus Fenestration vs Recession for PAET
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Medial Rectus Muscle Fenestration Versus Medial Rectus Recession for Partially Accommodative Esotropia
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 HSH
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 HSH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None