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

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ClinicalTrials.gov Identifier: NCT03135938
Recruitment Status : Unknown
Verified April 2017 by Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Asymmetric Dissociated Vertical Deviation Procedure: Grading Inferior Oblique Anterior Transposition surgery Procedure: Classic Inferior Oblique Anterior Transposition surgery Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Grading Versus Classic Inferior Oblique Anterior Transposition in Patient With Asymmetric Dissociated Vertical Deviation
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : November 1, 2017
Estimated Study Completion Date : December 1, 2017

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
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.

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
Procedure: 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




Primary Outcome Measures :
  1. Difference of DVD between two eyes [ Time Frame: three months after the surgery ]
    alternative prism cover test


Secondary Outcome Measures :
  1. Inferior oblique overaction [ Time Frame: three months after the surgery ]
    Evaluation of ocular motility in 9 visual gazes



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Ages Eligible for Study:   7 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT03135938


Contacts
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Contact: zhaleh rajavi, MD 009822591616 labbafi@hotmail.com

Locations
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Iran, Islamic Republic of
Islamic Republic of Iran Recruiting
Tehrān, Iran, Islamic Republic of
Contact: zhaleh rajavi, MD    9822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Responsible Party: Zahra Rabbani Khah, Ophthalmic Research center, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03135938    
Other Study ID Numbers: 95100
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases