Grading Versus Classic Inferior Oblique Anterior Transposition in Patient With Asymmetric Dissociated Vertical Deviation
NCT ID: NCT03135938
Last Updated: 2017-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
38 participants
INTERVENTIONAL
2017-08-01
2017-12-01
Brief Summary
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Methods: In this randomized clinical trial, a total of 38 patients with IOOA of \>+1 and a minimum DVD difference of 5pd between their two eyes will be included. Comprehensive ophthalmic examinations including visual acuity assessment, measurements of noncyclo- and cycloplegic refraction as well as ocular deviation, biomicroscopic and funduscopic evaluation will be performed at baseline and repeated three months after the surgery. The function of extra ocular muscles will be evaluated by duction and version movements denoting from -4 (underaction) to +4 (overaction) grades. Also, IOOA will be graded as +1 to +4 according to the covering of the cornea under the superior eyelid during the ocular movement towards supra-nasal direction. The difference of DVD≥5pd between two eyes will be considered as asymmetric DVD. All patients will be randomized in the two groups to undergo IOAT surgical procedure; in the classic group, IO muscle will be sutured to the sclera at the level of inferior rectus (IR) insertion at its temporal border, without considering the asymmetric DVD between the two eyes; while in the grading group, IO muscle of the eye with more severe DVD will be sutured at the level of IR insertion and IO muscle of the eye with lower magnitude of DVD will be sutured 2mm posterior to the sclera to consider the preoperative DVD difference between the two eyes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Grading Inferior Oblique Anterior Transposition
in the classic group, IO muscle will be sutured to the sclera at the level of inferior rectus (IR) insertion at its temporal border, without considering the asymmetric DVD between the two eyes
Grading Inferior Oblique Anterior Transposition surgery
in the grading group, IO muscle of the eye with more severe DVD will be sutured at the level of IR insertion and IO muscle of the eye with lower magnitude of DVD will be sutured 2mm posterior to the sclera to consider the preoperative DVD difference between the two eyes.
Classic Inferior Oblique Anterior Transposition
in the grading group, IO muscle of the eye with more severe DVD will be sutured at the level of IR insertion and IO muscle of the eye with lower magnitude of DVD will be sutured 2mm posterior to the sclera to consider the preoperative DVD difference between the two eyes
Classic Inferior Oblique Anterior Transposition surgery
in the classic group, IO muscle will be sutured to the sclera at the level of inferior rectus (IR) insertion at its temporal border, without considering the asymmetric DVD between the two eyes
Interventions
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Grading Inferior Oblique Anterior Transposition surgery
in the grading group, IO muscle of the eye with more severe DVD will be sutured at the level of IR insertion and IO muscle of the eye with lower magnitude of DVD will be sutured 2mm posterior to the sclera to consider the preoperative DVD difference between the two eyes.
Classic Inferior Oblique Anterior Transposition surgery
in the classic group, IO muscle will be sutured to the sclera at the level of inferior rectus (IR) insertion at its temporal border, without considering the asymmetric DVD between the two eyes
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Nystagmus
* Cerebral palsy
* History of ptosis and previous surgery on any cyclovertical muscle
* Restrictive or paralytic ocular deviations
* Inability to maintain fixation by each eye
* Best corrected visual acuity \<20/200
* Ocular and/or systemic anomalies
* Follow up less than three months
7 Years
35 Years
ALL
Yes
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Zahra Rabbani Khah
Ophthalmic Research center
Locations
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Islamic Republic of Iran
Tehrān, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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95100
Identifier Type: -
Identifier Source: org_study_id
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