Correction of V-pattern Strabismus by Graded Recession of Inferior Oblique Muscle .

NCT ID: NCT05786053

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-01-01

Brief Summary

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V pattern strabismus is the commonest of alphabet pattern. Its identification is essential to plan a proper surgical management. Graded recession is a very logical approach to treat inferior oblique overaction (IOOA). The aim Is to evaluate the efficacy of graded recession of inferior oblique muscle for correction of different grades of V pattern.

Detailed Description

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prospective interventional study for forty patients with V pattern strabismus and primary inferior oblique overeaction will be evaluated by prism cover test to assess the grade of IOOA and amplitude of V-pattern. Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11-15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA ( more than 15 degree or +3). Simultaneous correction of the horizontal deviation will be performed at the same sitting. Follow up after I week,1 month ,3 month and 6-month.

Conditions

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V Pattern Esotropia Monocular Exotropia With V Pattern

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Forty patients from 3 to 18 years old with V pattern strabismus and primary IOOA were evaluated by prism cover test to assess the grade of IOOA and amplitude of V-pattern. Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5to 10 degree and mild IOOA (10 degree or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 degree or +2) and maximum recession for amplitude more than 15 degree and marked IOOA (15 or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting. Follow up after one week,1 month ,3 month and 6-month.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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v pattern exotropia

v pattern exotropia patients with associated inferior oblique overreaction

Group Type ACTIVE_COMPARATOR

graded recession of inferior oblique muscle

Intervention Type PROCEDURE

. Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 degree or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA (more than15 degree or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting.

Pattern esotropia

v pattern esotropia patients with inferior oblique overreaction

Group Type ACTIVE_COMPARATOR

graded recession of inferior oblique muscle

Intervention Type PROCEDURE

. Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 degree or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA (more than15 degree or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting.

Interventions

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graded recession of inferior oblique muscle

. Graded recession of IO muscle depends on the amplitude of the V-pattern and degree of IOOA. Eight mm recession for amplitude 7.5 to 10 degree and mild IOOA (10 degree or +1) ,10 mm recession for amplitude 11- 15 degree and moderate IOOA (11 -15 or +2) and maximum recession for amplitude more than 15 degree and marked IOOA (more than15 degree or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Cases with V pattern strabismus with the age of the patients will be ≥3 years.

Exclusion Criteria

* \- Structural ocular pathology
* Significant neurodevelopmental delay
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Heba Shafik

Assistant professor of ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine

Tanta, El Gharbeya, Egypt

Site Status

Faculty of medicine

Tanta, ELGharbia, Egypt

Site Status

Countries

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Egypt

References

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Sokeer SH, Ali AL, Arafa ES, Awara AM, Shafik HM. Evaluation of graded recession of inferior oblique muscle for correction of different grades of V-pattern strabismus. BMC Ophthalmol. 2023 Nov 16;23(1):462. doi: 10.1186/s12886-023-03210-x.

Reference Type DERIVED
PMID: 37974078 (View on PubMed)

Other Identifiers

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34123/9/20

Identifier Type: -

Identifier Source: org_study_id

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