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Bil. LR Rec. Using Standard Tables VS Reduced Numbers in Intermittent Exo. in Children Under 6

Primary Purpose

Alternating Exotropia

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Standard Recession

Reduced Recession

About this trial

This is an interventional treatment trial for Alternating Exotropia

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with poor control intermittent exotropia (where poor control is defined as having a Newcastle score of 3 or more). (9)
Basic, pseudo- divergence excess and divergence excess types are included.
If associated with amblyopia it should be corrected before the surgical correction (where the visual acuity will be assessed by the single crowded HOTV test using a commercial projector).

Exclusion Criteria:

Intermittent exotropia of the convergence insufficiency type.
Intermittent exotropia with angle of deviation greater than 50 prism diopters.
Patients with previous squint surgery.
Patients with secondary deviation due to a sensory lesion or neurological condition.

Sites / Locations

Faculty of Medicine Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Recession

Reduced Recession

Arm Description

Bilateral lateral rectus muscle recession using standard tables stated by Parks.

Bilateral lateral rectus muscle recession using reduced numbers by one millimeter than the standard tables.

Outcomes

Primary Outcome Measures

Motor success rate

Number of patients with orthophoria (8 PD exophoria to 4 PD esophoria)

Secondary Outcome Measures

Pattern strabismus

Number of patients who develop pattern strabismus

Full Information

NCT ID

NCT04308538

First Posted

April 18, 2015

Last Updated

March 11, 2020

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04308538

Brief Title

Bil. LR Rec. Using Standard Tables VS Reduced Numbers in Intermittent Exo. in Children Under 6

Official Title

Bilateral Lateral Rectus Recession Using Standard Tables Versus Bilateral Lateral Rectus Recession Using Modified Reduced Numbers in Intermittent Exotropia in Children Less Than 6 Years Old

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2020 (Anticipated)

Primary Completion Date

April 2021 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

comparing the motor alignment and the incidence of postoperative esotropia following the correction of intermittent exotropia in children below 7 years by bilateral lateral rectus recession using the standard recession tables postulated by Parks versus correction using a reduced recession by one millimeter

6. Conditions and Keywords

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

Alternating Exotropia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Recession

Arm Type

Active Comparator

Arm Description

Bilateral lateral rectus muscle recession using standard tables stated by Parks.

Arm Title

Reduced Recession

Arm Type

Experimental

Arm Description

Bilateral lateral rectus muscle recession using reduced numbers by one millimeter than the standard tables.

Intervention Type

Procedure

Intervention Name(s)

Standard Recession

Intervention Description

Bilateral lateral rectus muscle recession will be performed through fornix approach using standard tables

Intervention Type

Procedure

Intervention Name(s)

Reduced Recession

Intervention Description

Bilateral lateral rectus muscle recession will be performed through fornix approach using reduced numbers

Primary Outcome Measure Information:

Title

Motor success rate

Description

Number of patients with orthophoria (8 PD exophoria to 4 PD esophoria)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Pattern strabismus

Description

Number of patients who develop pattern strabismus

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with poor control intermittent exotropia (where poor control is defined as having a Newcastle score of 3 or more). (9) Basic, pseudo- divergence excess and divergence excess types are included. If associated with amblyopia it should be corrected before the surgical correction (where the visual acuity will be assessed by the single crowded HOTV test using a commercial projector). Exclusion Criteria: Intermittent exotropia of the convergence insufficiency type. Intermittent exotropia with angle of deviation greater than 50 prism diopters. Patients with previous squint surgery. Patients with secondary deviation due to a sensory lesion or neurological condition.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Awadein, MD

Phone

+201223911743

ahmedawadein@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dina Hassanein, MD

Phone

+20 100 517 2781

drdhossam@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ayman Elshiaty, MD

Organizational Affiliation

Cairo University

Official's Role

Study Chair

Facility Information:

Facility Name

Faculty of Medicine Cairo university

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed Siam, Masters

Phone

1111447245

Ext

+20

dr_sheded@hotmail.com

First Name & Middle Initial & Last Name & Degree

Ahmed Awadein, doctorate

12. IPD Sharing Statement

Citations:

PubMed Identifier

14736781

Citation

Haggerty H, Richardson S, Hrisos S, Strong NP, Clarke MP. The Newcastle Control Score: a new method of grading the severity of intermittent distance exotropia. Br J Ophthalmol. 2004 Feb;88(2):233-5. doi: 10.1136/bjo.2003.027615.

Results Reference

background

PubMed Identifier

930997

Citation

Pratt-Johnson JA, Barlow JM, Tillson G. Early surgery in intermittent exotropia. Am J Ophthalmol. 1977 Nov;84(5):689-94. doi: 10.1016/0002-9394(77)90385-3. No abstract available.

Results Reference

result

PubMed Identifier

11162985

Citation

Abroms AD, Mohney BG, Rush DP, Parks MM, Tong PY. Timely surgery in intermittent and constant exotropia for superior sensory outcome. Am J Ophthalmol. 2001 Jan;131(1):111-6. doi: 10.1016/s0002-9394(00)00623-1.

Results Reference

result

PubMed Identifier

22887975

Citation

Buck D, Powell CJ, Sloper JJ, Taylor R, Tiffin P, Clarke MP; Improving Outcomes in Intermittent Exotropia (IOXT) Study group. Surgical intervention in childhood intermittent exotropia: current practice and clinical outcomes from an observational cohort study. Br J Ophthalmol. 2012 Oct;96(10):1291-5. doi: 10.1136/bjophthalmol-2012-301981. Epub 2012 Aug 11.

Results Reference

result

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Bil. LR Rec. Using Standard Tables VS Reduced Numbers in Intermittent Exo. in Children Under 6

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