NCT05234957: IXT

Symmetric vs Asymmetric BLR Recession in Management of Basic IXT With Ocular Dominance

Completed NA Results posted Last updated 10 December 2024

What this trial tests

NA trial testing Bilateral Lateral Rectus Recession in Intermittent Exotropia in 40 participants. Completed in 18 May 2023.

Timeline

17 April 2022

Primary endpoint
18 April 2023

18 May 2023

Quick facts

Lead sponsor	Benha University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	17 April 2022
Primary completion	18 April 2023
Estimated completion	18 May 2023
Sites	1 location across Egypt

Drugs / interventions tested

• Bilateral Lateral Rectus Recession

Conditions studied

• Intermittent Exotropia — all drugs for Intermittent Exotropia →

Sponsor

Benha University

Who can join

4 and older, any sex, with Intermittent Exotropia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ocular Alignment at Distant Fixation Primary · one year

ocular alignment in prism diopter (PD) at distant fixation (6 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.

Group	Value	95% CI
Group 1	5.8	± 5.54
Group 2	1.1	± 4.7

Ocular Alignment at Near Fixation Primary · one year

ocular alignment in prism diopter (PD) at near fixation (1/3 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.

Group	Value	95% CI
Group 1	6.6	± 5.52
Group 2	3.5	± 6.19

Sensory Status (Stereopsis) Secondary · one year

ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc.

Group	Value	95% CI
Group 1	124	± 81.3
Group 2	119.5	± 54.2

Sensory Status (Fusion) Secondary · one year

Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion).

Group	Value	95% CI
Group 1	5
Group 2	6
Group 1	15
Group 2	14

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1

Serious: 0/20 (0%)

Deaths: 0/20

Group 2

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (2 terms — click to expand)

Reaction	System	Group 1	Group 2
undercorrection/recurrence	Eye disorders	—	—
overcorrection	Eye disorders	—	—

Data from ClinicalTrials.gov NCT05234957 adverse events section.

Sponsor's own description

The study aims to investigate ocular motor and sensory outcomes of two different strategies of lateral rectus recession; symmetric and asymmetric, in management of basic type intermittent exotropia with ocular dominance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.