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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes. |
|
| Group 2 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Lateral Rectus Recession | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory Status (Stereopsis) | ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc. | one year |
| Sensory Status (Fusion) | Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Farid, MD | Benha University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University | Banhā | Qalyubiyya | 13511 | Egypt |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes. |
| FG001 | Group 2 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes. |
| BG001 | Group 2 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | prism diopter | one year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| undercorrection/recurrence | Eye disorders | Systematic Assessment | postoperative deviation equal or greater than 10 prism diopter exotropia/phoria at distant and/or near fixation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohamed Farid | Benha University | 00201003354636 | mohamed.farid@fmed.bu.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2021 | Aug 11, 2024 | Prot_SAP_000.pdf |
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|
| one year |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Best Corrected Visual Acuity Right Eye (BCVA/OD) | Mean | Standard Deviation | logMAR |
|
| Best Corrected Visual Acuity Left Eye (BCVA/OS) | Mean | Standard Deviation | logMAR |
|
| Spherical Equivalent Refractive Error Right Eye (SE/0D) | Mean | Standard Deviation | diopter |
|
| Spherical Equivalent Refractive Error Left Eye (SE/OS) | Mean | Standard Deviation | diopter |
|
| Ocular Dominance Right Eye | Count of Participants | Participants |
|
| Ocular Dominance Left Eye | Count of Participants | Participants |
|
| preoperative distant deviation | Mean | Standard Deviation | prism diopter |
|
| preoperative near deviation | Mean | Standard Deviation | prism diopter |
|
| Fusion | Assessment of binocular fusion by using Worth's dot test. Patients who can fuse are termed (positive fusion), and patients who can not fuse are termed (absent fusion). | Count of Participants | Participants |
|
| preoperative stereopsis | Mean | Standard Deviation | second of arc |
|
|
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| Primary | 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. | Posted | Mean | Standard Deviation | prism diopter | one year |
|
|
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| Secondary | Sensory Status (Stereopsis) | ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc. | Stereopsis | Posted | Mean | Standard Deviation | second of arc | one year |
|
|
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| Secondary | Sensory Status (Fusion) | Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion). | Posted | Count of Participants | Participants | one year |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | Group 2 | 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. | 0 | 20 | 0 | 20 | 5 | 20 |
|
| overcorrection | Eye disorders | Systematic Assessment | postoperative deviation equal or greater than 10 prism diopter esotropia/phoria at distant and/or near fixation. |
|
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