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Clinical Trials/NCT03555045
NCT03555045UnknownPhase 2

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

Shahid Beheshti University of Medical Sciences1 site in 1 country100 target enrollmentStarted: February 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Enrollment
100
Locations
1
Primary Endpoint
far-near deviation difference

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
6 Years to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

conducting the slanted recession technique

Active Comparator

conducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations.

Intervention: conducting the slanted recession technique on the superior and inferior poles (Procedure)

conducting the augmented recession technique on the muscle

Active Comparator

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

Intervention: conducting the augmented recession technique on the muscle (Procedure)

Outcomes

Primary Outcomes

far-near deviation difference

Time Frame: 90 days after surgery

difference between the far and near deviations

Secondary Outcomes

  • success rate of surgery(90 days after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zahra Rabbani Khah

Clinical Professor

Shahid Beheshti University of Medical Sciences

Study Sites (1)

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