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

June 12, 2018 updated by: Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
far-near deviation difference
Time Frame: 90 days after surgery
difference between the far and near deviations
90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate of surgery
Time Frame: 90 days after surgery
in cases with difference of far and near deviation less than 10 prism diopters
90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

July 1, 2017

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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