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

NCT ID: NCT04308538

Last Updated: 2020-03-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2022-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Alternating Exotropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard Recession

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

Group Type ACTIVE_COMPARATOR

Standard Recession

Intervention Type PROCEDURE

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

Reduced Recession

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

Group Type EXPERIMENTAL

Reduced Recession

Intervention Type PROCEDURE

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

Interventions

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Standard Recession

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

Intervention Type PROCEDURE

Reduced Recession

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Awadein

Prof.Ahmed Awadein

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman Elshiaty, MD

Role: STUDY_CHAIR

Cairo University

Locations

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Faculty of Medicine Cairo university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Awadein, MD

Role: CONTACT

+201223911743

Dina Hassanein, MD

Role: CONTACT

+20 100 517 2781

Facility Contacts

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Ahmed Siam, Masters

Role: primary

1111447245 ext. +20

References

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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.

Reference Type BACKGROUND
PMID: 14736781 (View on PubMed)

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.

Reference Type RESULT
PMID: 930997 (View on PubMed)

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.

Reference Type RESULT
PMID: 11162985 (View on PubMed)

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.

Reference Type RESULT
PMID: 22887975 (View on PubMed)

Other Identifiers

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D-20-2020

Identifier Type: -

Identifier Source: org_study_id

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