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Status unknownNCT04308538Updated Mar 16, 2020

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

An interventional study of Standard Recession and Reduced Recession in Alternating Exotropia, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2020-03-16.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
2 Years to 6 Years
Sex
All
01

Study 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

02

Conditions studied

  • Alternating Exotropia

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03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 49 interventional studies indexed under Exotropia.

Browse Exotropia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Standard Recession

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

    Procedure: Standard Recession

  • Experimental
    Reduced Recession

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

    Procedure: Reduced Recession

Interventions

  • ProcedureStandard Recession

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

  • ProcedureReduced Recession

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

06

What researchers measure

Primary outcomes

  1. Motor success rate

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

    Time frame: 6 months

Secondary outcomes

  1. Pattern strabismus

    Number of patients who develop pattern strabismus

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Medicine Cairo university
    Cairo, Egypt
    Recruiting
    • Ahmed Siam, Masters · Contactdr_sheded@hotmail.com · 1111447245
    • Ahmed Awadein, doctorate · Principal investigator
08

References and documents

Publications

  • 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. PubMed 14736781 ↗
  • 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. PubMed 930997 ↗
  • 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. PubMed 11162985 ↗
  • 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. PubMed 22887975 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04308538
Lead sponsor
Cairo University
Responsible party
Ahmed Awadein (Prof.Ahmed Awadein, Cairo University) — Principal investigator
First posted
Mar 16, 2020
Start date
Apr 1, 2020 (estimated)
Primary completion
Apr 2021 (estimated)
Completion
Apr 2022 (estimated)
Last update
Mar 16, 2020

Study contacts

Ahmed Awadein, MD
Contact
ahmedawadein@yahoo.com
+201223911743
Dina Hassanein, MD
Contact
drdhossam@yahoo.com
+20 100 517 2781
Ayman Elshiaty, MD
study chair · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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