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Symmetrical Versus Asymmetrical Surgery for Asymmetrical Inferior Oblique Overaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507712
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : August 6, 2020
Sponsor:
Collaborator:
Christian Medical College, Vellore, India
Information provided by (Responsible Party):
Anuradha Ganesh, Sultan Qaboos University

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.


Condition or disease Intervention/treatment Phase
Strabismus Procedure: Symmetrical IO weakening Procedure: Asymmetrical IO weakening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: Both participants and outcome assessor (the orthoptist) will be blinded regarding the type of surgery
Primary Purpose: Treatment
Official Title: Symmetrical Versus Asymmetrical Inferior Oblique Muscle Weakening Surgery for Asymmetrical Inferior Oblique Overaction
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Active Comparator: Symmetrical IO weakening.
Same surgery in both eyes
Procedure: Symmetrical IO weakening
Bilateral IO Myectomy / Bilateral equal graded IO Recession

Active Comparator: Asymmetrical IO weakening.
Different amounts or different surgery in each eye
Procedure: Asymmetrical IO weakening
IO Myectomy in one eye - IO Recession in the fellow eye / Bilateral IO Recession (different amounts) in each eye




Primary Outcome Measures :
  1. Normalization of IO action [ Time Frame: 3 months ]
    To compare effect of symmetrical vs asymmetrical IO weakening in reducing IOOA (scale of +1 to +4)


Secondary Outcome Measures :
  1. Vertical ocular alignment [ Time Frame: 3 months ]
    To compare the effect of symmetrical vs asymmetrical IO weakening in producing vertical alignment (within 3 PD of orthotropia)

  2. Collapse of "V" pattern [ Time Frame: 3 months ]
    To compare the effect of symmetrical vs asymmetrical IO weakening in collapsing the "V" pattern (difference in deviation in upgaze and downgaze within 5 PD)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507712


Contacts
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Contact: Anuradha Ganesh, MD 24144547 gananu@gmail.com

Locations
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Oman
Sultan Qaboos University Recruiting
Muscat, Oman
Contact: Anuradha Ganesh, MD    24144547    gananu@gmail.com   
Sub-Investigator: Sana Al Zuhaibi, MD         
Sub-Investigator: Maha Mameesh, MD         
Sub-Investigator: Sreelatha OK, MSc         
Sub-Investigator: Majda Al Yahyai, MD         
Sponsors and Collaborators
Sultan Qaboos University
Christian Medical College, Vellore, India
Investigators
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Principal Investigator: Anuradha Ganesh, MD Sultan Qaboos University
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Responsible Party: Anuradha Ganesh, Senior Consultant, Sultan Qaboos University
ClinicalTrials.gov Identifier: NCT03507712    
Other Study ID Numbers: MREC 1474
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anuradha Ganesh, Sultan Qaboos University:
Asymmetric, Inferior Oblique, Overaction, Surgery, Symmetric
Additional relevant MeSH terms:
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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases