Symmetrical Versus Asymmetrical Surgery for Asymmetrical Inferior Oblique Overaction

NCT03507712 | Unknown

• 1 other identifier: MREC 1474
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Overaction of the inferior oblique (IO) muscle is a commonly observed component of childhood strabismus, and is often seen combined with other ocular deviations. It manifests with excessive elevation of the affected eye in adduction, and may cause a pattern strabismus and vertical deviation of the affected eye. IO overaction (IOOA) may be primary or secondary to superior oblique underaction, is often bilateral, and may be symmetrical or asymmetrical. Surgical management of the overacting IO muscle is often required to achieve ocular alignment. The most commonly performed IO muscle weakening procedures are IO myectomy and graded IO recession. The surgical decision is primarily based on degree of overaction of the IO muscle. Various studies have compared the two IO weakening procedures and have reported a similar success rate for both procedures. The aim of this study is to compare the effect of two IO weakening procedures (symmetrical vs asymmetrical myectomy or graded recession) in normalizing the IOOA, obtaining vertical alignment and collapse of pattern, when employed in the treatment of asymmetrical IOOA.

Conditions

Strabismus

Keywords

Asymmetric, Inferior Oblique, Overaction, Surgery, Symmetric

Outcome Measures

Primary Outcomes (1)

• Normalization of IO action

  To compare effect of symmetrical vs asymmetrical IO weakening in reducing IOOA (scale of +1 to +4)

  3 months

Secondary Outcomes (2)

• Vertical ocular alignment

  3 months

• Collapse of "V" pattern

  3 months

Study Arms (2)

Symmetrical IO weakening.

ACTIVE COMPARATOR

Same surgery in both eyes

Procedure: Symmetrical IO weakening

Asymmetrical IO weakening.

ACTIVE COMPARATOR

Different amounts or different surgery in each eye

Procedure: Asymmetrical IO weakening

Interventions

Symmetrical IO weakening PROCEDURE

Bilateral IO Myectomy / Bilateral equal graded IO Recession

Symmetrical IO weakening.

Asymmetrical IO weakening PROCEDURE

IO Myectomy in one eye - IO Recession in the fellow eye / Bilateral IO Recession (different amounts) in each eye

Asymmetrical IO weakening.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Comitant esotropia or exotropia with bilateral, asymmetrical IOOA
• Vertical deviation in primary position \< 15 PD
• Minimum of 3 months follow up

You may not qualify if:

• Paralytic or Restrictive Strabismus
• Dissociated vertical deviation
• History of previous IO surgery

Sponsors & Collaborators

• Sultan Qaboos University: lead
• Christian Medical College, Vellore, India: collaborator

Study Sites (1)

Sultan Qaboos University

Muscat, Oman

RECRUITING

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

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

Study Officials

• Anuradha Ganesh, MD

  Sultan Qaboos University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anuradha Ganesh, MD

CONTACT

24144547; gananu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and outcome assessor (the orthoptist) will be blinded regarding the type of surgery
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: Group I: Symmetrical IO weakening surgery - Bilateral IO Myectomy / Bilateral equal graded IO Recession (Same surgery in both eyes). Group II: Asymmetrical IO weakening surgery - IO Myectomy in one eye - IO Recession in the fellow eye / Bilateral IO Recession (different amounts) in each eye.

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: April 25, 2018
• Study Start: July 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

OM (1)