Grading Versus Classic Inferior Oblique Anterior Transposition in Patient With Asymmetric Dissociated Vertical Deviation (Grading vs)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Tehrān, Iran, Islamic Republic of
- Recruiting
- Islamic Republic of Iran
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Contact:
- zhaleh rajavi, MD
- Phone Number: 9822591616
- Email: labbafi@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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
|
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.
|
|
Active Comparator: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference of DVD between two eyes
Time Frame: three months after the surgery
|
alternative prism cover test
|
three months after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inferior oblique overaction
Time Frame: three months after the surgery
|
Evaluation of ocular motility in 9 visual gazes
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three months after the surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 95100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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