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

Primary Purpose

Asymmetric Dissociated Vertical Deviation

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Grading Inferior Oblique Anterior Transposition surgery
Classic Inferior Oblique Anterior Transposition surgery
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asymmetric Dissociated Vertical Deviation

Eligibility Criteria

7 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Islamic Republic of IranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Grading Inferior Oblique Anterior Transposition

Classic Inferior Oblique Anterior Transposition

Arm Description

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

Outcomes

Primary Outcome Measures

Difference of DVD between two eyes
alternative prism cover test

Secondary Outcome Measures

Inferior oblique overaction
Evaluation of ocular motility in 9 visual gazes

Full Information

First Posted
April 20, 2017
Last Updated
April 26, 2017
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03135938
Brief Title
Grading Versus Classic Inferior Oblique Anterior Transposition in Patient With Asymmetric Dissociated Vertical Deviation
Acronym
Grading vs
Official Title
Grading Versus Classic Inferior Oblique Anterior Transposition in Patient With Asymmetric Dissociated Vertical Deviation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Anticipated)
Primary Completion Date
November 1, 2017 (Anticipated)
Study Completion Date
December 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymmetric Dissociated Vertical Deviation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Grading Inferior Oblique Anterior Transposition
Arm Type
Active Comparator
Arm Description
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
Arm Title
Classic Inferior Oblique Anterior Transposition
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Grading Inferior Oblique Anterior Transposition surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Classic Inferior Oblique Anterior Transposition surgery
Intervention Description
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 Measure Information:
Title
Difference of DVD between two eyes
Description
alternative prism cover test
Time Frame
three months after the surgery
Secondary Outcome Measure Information:
Title
Inferior oblique overaction
Description
Evaluation of ocular motility in 9 visual gazes
Time Frame
three months after the surgery

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhaleh rajavi, MD
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Islamic Republic of Iran
City
Tehrān
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhaleh rajavi, MD
Phone
9822591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

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

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