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

Horizontal Strabismus With High AC/A Ratio Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03555045
• Other study ID #: 96302
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 1, 2017
• Est. completion date: May 2019

Study information

• Verified date: January 2018
• Source: Shahid Beheshti University of Medical Sciences
• Contact: zhaleh rajavi, MD
• Phone: 9822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2019
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Horizontal Strabismus With High AC/A Ratio
• Strabismus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	far-near deviation difference	difference between the far and near deviations	90 days after surgery
Secondary	success rate of surgery	in cases with difference of far and near deviation less than 10 prism diopters	90 days after surgery