Symmetrical Versus Asymmetrical Surgery for Asymmetrical Inferior Oblique Overaction
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|ClinicalTrials.gov Identifier: NCT03507712|
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : August 6, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|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|
|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|
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
- 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)
- 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)
- 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)
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
|Contact: Anuradha Ganesh, MDemail@example.com|
|Sultan Qaboos University||Recruiting|
|Contact: Anuradha Ganesh, MD 24144547 firstname.lastname@example.org|
|Sub-Investigator: Sana Al Zuhaibi, MD|
|Sub-Investigator: Maha Mameesh, MD|
|Sub-Investigator: Sreelatha OK, MSc|
|Sub-Investigator: Majda Al Yahyai, MD|
|Principal Investigator:||Anuradha Ganesh, MD||Sultan Qaboos University|