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The Effect of Slanted Recession of Horizontal Muscle on Horizontal Strabismus With Abnormal Accommodative Convergence /Accommodation Ratio (AC/A)

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ClinicalTrials.gov Identifier: NCT03555045
Recruitment Status : Unknown
Verified January 2018 by Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Brief Summary:

Different methods was tried to treat high AC/A strabismus cases;such as prescription of bifocal glasses in esotropia,recession of horizontal muscles with posterior fixation sutures,more recession than needed for far deviation(augmented recession),recession and pulley fixation and slant recession.

Different results was reported for any type of above methods. In recent studies,slanted recession was applied for high AC/A in esotropic cases and success rate of 67% was reported.but there was no unanimity for procedure of choice.

Since slant recession method is simpler and has low side effect than the other methods,therefore in this study the investigators want to peruse the outcome of this method on high AC/A horizontal strabismus.


Condition or disease Intervention/treatment Phase
Horizontal Strabismus With High AC/A Ratio Procedure: conducting the slanted recession technique on the superior and inferior poles Procedure: conducting the augmented recession technique on the muscle Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Slanted Recession of Horizontal Muscle on Horizontal Strabismus With Abnormal Accommodative Convergence /Accommodation Ratio (AC/A)
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : July 1, 2017
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Active Comparator: conducting the slanted recession technique
conducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations.
Procedure: conducting the slanted recession technique on the superior and inferior poles
conducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations.

Active Comparator: conducting the augmented recession technique on the muscle
conducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method.
Procedure: conducting the augmented recession technique on the muscle
conducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method.




Primary Outcome Measures :
  1. far-near deviation difference [ Time Frame: 90 days after surgery ]
    difference between the far and near deviations


Secondary Outcome Measures :
  1. success rate of surgery [ Time Frame: 90 days after surgery ]
    in cases with difference of far and near deviation less than 10 prism diopters



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Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all patients with horizontal strabismus that the different between far deviation and near deviation is more than 10 pd

Exclusion Criteria:

  • all patients who had history of surgery on horizontal muscles and patients with pseudo high AC/A ratio.

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 ClinicalTrials.gov identifier (NCT number): NCT03555045


Contacts
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Contact: zhaleh rajavi, MD 9822591616 labbafi@hotmail.com

Locations
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Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: zhaleh Rajavi, MD    9822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Responsible Party: Zahra Rabbani Khah, Clinical Professor, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03555045    
Other Study ID Numbers: 96302
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: January 2018

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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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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases