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

Primary Purpose

V Pattern Esotropia, Monocular Exotropia With V Pattern

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

graded recession of inferior oblique muscle

About this trial

This is an interventional treatment trial for V Pattern Esotropia focused on measuring Vpattern strabismus, inferior oblique overaction, graded recession, Dissociated vertical deviation

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Faculty of medicine
Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

v pattern exotropia

Pattern esotropia

Arm Description

v pattern exotropia patients with associated inferior oblique overreaction

v pattern esotropia patients with inferior oblique overreaction

Outcomes

Primary Outcome Measures

orthotropia in primary position with no v pattern esotropia or exotropia.

by measuring the distant angle of strabismus in primary and upgaze less than 10prism dioptre.

Secondary Outcome Measures

No Inferior oblique overaction

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.

Full Information

NCT ID

NCT05786053

First Posted

February 20, 2023

Last Updated

March 23, 2023

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT05786053

Brief Title

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

Acronym

Pattern

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

January 31, 2022 (Actual)

Study Completion Date

January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

V Pattern Esotropia, Monocular Exotropia With V Pattern

Keywords

Vpattern strabismus, inferior oblique overaction, graded recession, Dissociated vertical deviation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

v pattern exotropia

Arm Type

Active Comparator

Arm Description

v pattern exotropia patients with associated inferior oblique overreaction

Arm Title

Pattern esotropia

Arm Type

Active Comparator

Arm Description

v pattern esotropia patients with inferior oblique overreaction

Intervention Type

Procedure

Intervention Name(s)

graded recession of inferior oblique muscle

Intervention Description

. 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.

Primary Outcome Measure Information:

Title

orthotropia in primary position with no v pattern esotropia or exotropia.

Description

by measuring the distant angle of strabismus in primary and upgaze less than 10prism dioptre.

Time Frame

6 month

Secondary Outcome Measure Information:

Title

No Inferior oblique overaction

Description

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Faculty of medicine

City

Tanta

State/Province

El Gharbeya

ZIP/Postal Code

1333

Country

Egypt

Facility Name

Faculty of medicine

City

Tanta

State/Province

ELGharbia

ZIP/Postal Code

1333

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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