Grading Versus Classic Inferior Oblique Anterior Transposition in Patient With Asymmetric Dissociated Vertical Deviation

Study Overview
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Brief Summary
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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.

Official Title
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Grading Versus Classic Inferior Oblique Anterior Transposition in Patient With Asymmetric Dissociated Vertical Deviation

Conditions
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Asymmetric Dissociated Vertical Deviation

Intervention / Treatment
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* Procedure: Grading Inferior Oblique Anterior Transposition surgery
* Procedure: Classic Inferior Oblique Anterior Transposition surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Overaction of inferior oblique muscle ≥+1 and asymmetric dissociated vertical deviation >5pd between their two eyes. Exclusion Criteria: Mental retardation 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Grading Inferior Oblique Anterior Transposition<br>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<br>* 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.<br>|
| Active Comparator: Classic Inferior Oblique Anterior Transposition<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of DVD between two eyes | alternative prism cover test | three months after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inferior oblique overaction | Evaluation of ocular motility in 9 visual gazes | three months after the surgery |