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Augmented Medial Rectus Muscle Recession Versus Posterior Scleral Fixation in Partially Accommodative Esotropia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02413463
Recruitment Status : Completed
First Posted : April 10, 2015
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):
Ahmed Awadein, Cairo University

Brief Summary:
Prospective randomized interventional comparative study

Condition or disease Intervention/treatment Phase
Partially Accommodative Esotropia Procedure: augmented recession Procedure: Faden Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmented Medial Rectus Muscle Recession Versus Medial Rectus Recession With Posterior Scleral Fixation in Partially Accommodative Esotropia
Study Start Date : January 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Augmented recession
The medial rectus muscle will be exposed and hooked through a limbal approach. The muscle will then be secured with 6-0 polyglactin sutures. The medial rectus muscles will then be recessed using standard tables with the surgical dose targeting the average of the largest and smallest angles
Procedure: augmented recession
medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)

Active Comparator: Faden
Medial rectus muscle recession will be performed as described above with the surgical dose targeting the smallest pre-operative angle. The muscle will then fixated to the sclera using 6/0 polyester sutures placed in a mattress like with the anterior and the posterior sutures passing through both the edge of muscle and the sclera 12 mm and 14 mm from the muscle insertion, respectively.
Procedure: Faden
medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)
Other Name: Posterior scleral fixation

Primary Outcome Measures :
  1. Success Rate [ Time Frame: six months ]
    Success rate defined as orthotropia or esotropia ≤ 8 prism diopters with the full hypermetropic correction for near and far without changing the preoperative correction.

Secondary Outcome Measures :
  1. Angle of Deviation With Spectacles for Both Distance and Near [ Time Frame: Six months ]
    The angle of deviation after surgery with full hypermetropic correction

  2. Angle of Deviation Without Spectacles for Both Distance and Near [ Time Frame: Six months ]
    The angle of deviation after surgery without correction for both distance and near

  3. Angle Disparity [ Time Frame: Six months ]
    Difference between largest angle and smallest angle

  4. Surgery Time [ Time Frame: Intraoperative time ]
    Time to complete the surgery

  5. Number of Patients Who Developed Intraoperative and/or Postoperative Complications [ Time Frame: Six months ]
    Number of patients who developed intraoperative and postoperative complications as scleral perforation, fat prolapse, slipped and lost muscles

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acquired residual esotropia greater than 14 PD at distance fixation that exists despite full correction of hypermetropic refractive error with the angle of deviation for near not exceeding that of distance by more than 15 PD
  • Lack of previous extra ocular muscle surgery

Exclusion Criteria:

  • Fully accommodative esotropia, partially accommodative esotropia with convergence excess, non-accommodative esotropia or infantile esotropia
  • The presence of neurologic, developmental or ocular structural disorders
  • History of previous eye surgery
  • Patients requiring simultaneous oblique muscles surgery
  • Follow up less than 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02413463

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Cairo University Hospital
Cairo, Egypt
Sponsors and Collaborators
Cairo University
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Principal Investigator: Ahmed Awadein, MD Cairo University
  Study Documents (Full-Text)

Documents provided by Ahmed Awadein, Cairo University:
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Responsible Party: Ahmed Awadein, Professor of Ophthalmology, Cairo University Identifier: NCT02413463    
Other Study ID Numbers: HHH
First Posted: April 10, 2015    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases