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

Alternating Exotropia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04308538
• Other study ID #: D-20-2020
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: April 2022

Study information

• Verified date: March 2020
• Source: Cairo University
• Contact: Ahmed Awadein, MD
• Phone: +201223911743
• Email: ahmedawadein[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alternating Exotropia
• Exotropia

Intervention

Procedure:
• Standard Recession
Bilateral lateral rectus muscle recession will be performed through fornix approach using standard tables
• Reduced Recession
Bilateral lateral rectus muscle recession will be performed through fornix approach using reduced numbers

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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 st — View 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. — View Citation

Pratt-Johnson JA, Barlow JM, Tillson G. Early surgery in intermittent exotropia. Am J Ophthalmol. 1977 Nov;84(5):689-94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor success rate	Number of patients with orthophoria (8 PD exophoria to 4 PD esophoria)	6 months
Secondary	Pattern strabismus	Number of patients who develop pattern strabismus	6 months