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

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03135938
Acronym
Grading vs
Enrollment
38
Registered
2017-05-02
Start date
2017-08-01
Completion date
2017-12-01
Last updated
2017-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymmetric Dissociated Vertical Deviation

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.

Interventions

PROCEDUREGrading 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.

PROCEDUREClassic 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

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
7 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Difference of DVD between two eyesthree months after the surgeryalternative prism cover test

Secondary

MeasureTime frameDescription
Inferior oblique overactionthree months after the surgeryEvaluation of ocular motility in 9 visual gazes

Countries

Iran

Contacts

Primary Contactzhaleh rajavi, MD
labbafi@hotmail.com009822591616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026