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

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT05786053

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
V Pattern Esotropia Monocular Exotropia With V Pattern	Procedure: graded recession of inferior oblique muscle	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Graded Recession of Inferior Oblique Muscle for Correction of Different Grades of V-pattern Strabismus

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: v pattern exotropia v pattern exotropia patients with associated inferior oblique overreaction	Procedure: 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.
Active Comparator: Pattern esotropia v pattern esotropia patients with inferior oblique overreaction	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: v pattern exotropia

v pattern exotropia patients with associated inferior oblique overreaction

Procedure: 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.

Active Comparator: Pattern esotropia

v pattern esotropia patients with inferior oblique overreaction

Procedure: graded recession of inferior oblique muscle

Outcome Measures

Primary Outcome Measures

orthotropia in primary position with no v pattern esotropia or exotropia. [6 month]
by measuring the distant angle of strabismus in primary and upgaze less than 10prism dioptre.

Secondary Outcome Measures

No Inferior oblique overaction [6 month]
2.No hypertropia in adducted position.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 degreeor +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 ( 15 or +3). Simultaneous correction of the horizontal deviation was performed at the same sitting.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine	Tanta	El Gharbeya	Egypt	1333
2	Faculty of medicine	Tanta	ELGharbia	Egypt	1333

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heba Shafik, Assistant professor of ophthalmology, Tanta University

ClinicalTrials.gov Identifier:

NCT05786053

Other Study ID Numbers:

34123/9/20

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Heba Shafik, Assistant professor of ophthalmology, Tanta University

Vpattern strabismus

inferior oblique overaction

graded recession

Dissociated vertical deviation

Additional relevant MeSH terms:

Strabismus

Exotropia

Esotropia

Study Results

No Results Posted as of Mar 27, 2023