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

NCT ID: NCT03555045

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2019-05-31

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.

Conditions

Horizontal Strabismus With High AC/A Ratio

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

conducting the slanted recession technique on the superior and inferior poles

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

conducting the augmented recession technique on the muscle

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zahra Rabbani Khah

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ophthalmic Research Center

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

zhaleh rajavi, MD

Role: CONTACT

labbafi@hotmail.com

9822591616

Facility Contacts

zhaleh Rajavi, MD

Role: primary

labbafi@hotmail.com

9822591616

Other Identifiers

96302

Identifier Type: -

Identifier Source: org_study_id