NCT04307160

Brief Summary

It is prospective cohort study to compare ( the surgical outcome) the motor and sensory outcome of early surgery (≤5 years of age) and late surgery ( ≥ 7 years of age) for intermittent exotropia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

March 11, 2020

Last Update Submit

March 11, 2020

Conditions

Intermittent Exotropia

Outcome Measures

Primary Outcomes (1)

  • Motor success rate

    Success rate defined as deviation between exotropia/phoria of 8 PD to esotropia/phoria of 4 PD

    Six months

Secondary Outcomes (3)

  • Change in stereoacuity

    Six months

  • New misalignment

    Six months

  • Pattern deviation

    Six months

Study Arms (2)

Group I

Patients ≤ 5 years of age

Procedure: Bilateral lateral rectus recession

Group II

Patients ≥ 7 years of age

Procedure: Bilateral lateral rectus recession

Interventions

Bilateral lateral rectus recessionPROCEDURE

All patients will undergo bilateral lateral rectus recession according to standard tables. In the younger age group, the amount of lateral rectus recession will be reduced by 0.5 mm. in those with inferior oblique overaction, inferior oblique recession will be performed

Group IGroup II

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

One hundred and twenty four patients with intermittent exotropia will be included in this study in form of two groups based on the age at the first surgery; each group including 62 patients * Group I patients ≤ 5 years of age * Group II patients ≥ 7 years of age Patients will be recruited from Kasr El Ainy and Cairo University Children Hospitals

You may qualify if:

  • All patients with intermittent exotropia in whom surgery is indicated

You may not qualify if:

  • Patients with prior eye muscle surgery, restrictive or paralytic strabismus will be excluded. In addition, patients with craniofacial anomalies or neurological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 22887975BACKGROUND

  • Richard JM, Parks MM. Intermittent exotropia. Surgical results in different age groups. Ophthalmology. 1983 Oct;90(10):1172-7.

    PMID: 6657192RESULT

  • 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.

    PMID: 930997RESULT

  • 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.

    PMID: 14736781RESULT

  • 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.

    PMID: 11162985RESULT

  • Choi J, Kim SJ, Yu YS. Initial postoperative deviation as a predictor of long-term outcome after surgery for intermittent exotropia. J AAPOS. 2011 Jun;15(3):224-9. doi: 10.1016/j.jaapos.2010.12.019. Epub 2011 Jun 12.

    PMID: 21665502RESULT

Related Links

Study Officials

  • Ayman Elshiaty, MD

    Head of Ophthalmology Department, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Ahmed R Awadein, MD

CONTACT

00201223911743ahmedawadein@yahoo.com

Jylan A Gouda, MSc

CONTACT

00201285430887gilangouda@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 13, 2020

Study Start

April 1, 2020

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

March 13, 2020

Record last verified: 2020-03