An interventional study of Bilateral Lateral Rectus Recession in Intermittent Exotropia, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
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.
Surgical management of basic -type intermittent exotropia with a dominant eye is controversial. Some surgeons do traditional symmetrical bilateral lateral rectus recession, while other perform unilateral recess-resect procedure in the non-dominant eye. The aim of this study is to investigate the effect of two different strategies of bilateral lateral rectus recession; symmetrical recession in which the amount of recession is equally divided between both eyes, and asymmetrical recession, in which the amount of recession is 2mm more in the non-dominant. Outcome measures include ocular deviation at distant and near fixation, sensory status and complications.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 49 interventional studies indexed under Exotropia.
Browse Exotropia studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.
Procedure: Bilateral Lateral Rectus Recession
Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.
Procedure: Bilateral Lateral Rectus Recession
Symmetric bilateral lateral rectus muscle recession involves equal recession of both lateral rectus muscles. Asymmetric bilateral lateral rectus muscle recession involves recession of the lateral rectus muscle by 2mm more in the non-dominant eye.
Ocular Alignment at Distant Fixation
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.
Time frame: one year
Ocular Alignment at Near Fixation
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.
Time frame: one year
Sensory Status (Stereopsis)
ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc.
Time frame: one year
Sensory Status (Fusion)
Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion).
Time frame: one year
| Milestone | Group 1 | Group 2 |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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.
| prism diopter | Group 1 | Group 2 |
|---|---|---|
| Ocular Alignment at Distant Fixation | 5.8 ± 5.54 | 1.1 ± 4.7 |
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.
| prism diopter | Group 1 | Group 2 |
|---|---|---|
| Ocular Alignment at Near Fixation | 6.6 ± 5.52 | 3.5 ± 6.19 |
ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc.
| second of arc | Group 1 | Group 2 |
|---|---|---|
| Sensory Status (Stereopsis) | 124 ± 81.3 | 119.5 ± 54.2 |
Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion).
| Participants | Group 1 | Group 2 |
|---|---|---|
| positive fusion | 5 | 6 |
| absent fusion | 15 | 14 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/20 (0%) | 0/20 (0%) | 8/20 (40%) |
| Group 2 | 0/20 (0%) | 0/20 (0%) | 5/20 (25%) |
| Event | Group 1 | Group 2 |
|---|---|---|
| undercorrection/recurrenceEye disorders | 8/20 | 4/20 |
| overcorrectionEye disorders | 0/20 | 1/20 |
| Age, Continuous(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 9.85 ± 5.42 | 8.75 ± 5.48 | 9.3 ± 5.41 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 9 | 9 | 18 |
| Race (NIH/OMB)(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 20 | 20 | 40 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Egypt | 20 | 20 | 40 |
| Best Corrected Visual Acuity Right Eye (BCVA/OD)(logMAR) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 0.05 ± 0.06 | 0.02 ± 0.06 | 0.03 ± 0.06 |
| Best Corrected Visual Acuity Left Eye (BCVA/OS)(logMAR) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 0.06 ± 0.09 | 0.03 ± 0.07 | 0.05 ± 0.08 |
| Spherical Equivalent Refractive Error Right Eye (SE/0D)(diopter) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | -0.03 ± 0.74 | -0.41 ± 1.3 | -0.22 ± 1.08 |
| Spherical Equivalent Refractive Error Left Eye (SE/OS)(diopter) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 0.1 ± 0.89 | -0.55 ± 2.18 | -0.22 ± 1.68 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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