A Phase 1/2 interventional study of Grading Inferior Oblique Anterior Transposition surgery and Classic Inferior Oblique Anterior Transposition surgery in Asymmetric Dissociated Vertical Deviation, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 7 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-02.
Sponsored by Shahid Beheshti University of Medical Sciences · Phase 1/2, Interventional, and Treatment
Purpose: To determine the surgical outcomes of the grading versus classic Inferior Oblique Anterior Transposition (IOAT) technique in treatment of patients with asymmetric dissociated vertical deviation (DVD) and inferior oblique overaction (IOOA).
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.
156 studies on the registry are indexed under Strabismus; 29 are open to participants now.
This study's planned enrollment of 38 is below the median of 60 across 95 interventional studies indexed under Strabismus.
Browse Strabismus studies →Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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
Procedure: 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
Procedure: Classic 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.
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
Difference of DVD between two eyes
alternative prism cover test
Time frame: three months after the surgery
Inferior oblique overaction
Evaluation of ocular motility in 9 visual gazes
Time frame: three months after the surgery
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University of Medical Sciences