Intermittent Exotropia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBilateral 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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Basic-type intermittent exotropia * Simulated distant-type intermittent exotropia
Exclusion criteria
* Alternating basic-type intermittent exotropia (no ocular dominance) * Distant-type intermittent exotropia * Convergence-insufficiency type intermittent exotropia * Constant exotropia * Sensory exotropia * Deep amblyopia * Paralytic or restrictive exotropia * Previous extraocular muscle surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Alignment at Distant Fixation | 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. |
| Ocular Alignment at Near Fixation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensory Status (Stereopsis) | one year | ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc. |
| Sensory Status (Fusion) | one year | Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion). |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes. | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Total | Group 1 | Group 2 |
|---|---|---|---|
| Age, Continuous | 9.3 years STANDARD_DEVIATION 5.41 | 9.85 years STANDARD_DEVIATION 5.42 | 8.75 years STANDARD_DEVIATION 5.48 |
| Best Corrected Visual Acuity Left Eye (BCVA/OS) | 0.05 logMAR STANDARD_DEVIATION 0.08 | 0.06 logMAR STANDARD_DEVIATION 0.09 | 0.03 logMAR STANDARD_DEVIATION 0.07 |
| Best Corrected Visual Acuity Right Eye (BCVA/OD) | 0.03 logMAR STANDARD_DEVIATION 0.06 | 0.05 logMAR STANDARD_DEVIATION 0.06 | 0.02 logMAR STANDARD_DEVIATION 0.06 |
| Fusion absent fusion | 29 Participants | 15 Participants | 14 Participants |
| Fusion positive fusion | 11 Participants | 5 Participants | 6 Participants |
| Ocular Dominance Left Eye | 12 Participants | 4 Participants | 8 Participants |
| Ocular Dominance Right Eye | 28 Participants | 16 Participants | 12 Participants |
| preoperative distant deviation | 34.25 prism diopter STANDARD_DEVIATION 8.2 | 36.25 prism diopter STANDARD_DEVIATION 9.01 | 32.25 prism diopter STANDARD_DEVIATION 6.97 |
| preoperative near deviation | 34.5 prism diopter STANDARD_DEVIATION 8.97 | 36.25 prism diopter STANDARD_DEVIATION 10.1 | 32.75 prism diopter STANDARD_DEVIATION 7.51 |
| preoperative stereopsis | 257 second of arc STANDARD_DEVIATION 169.8 | 251 second of arc STANDARD_DEVIATION 171.4 | 263 second of arc STANDARD_DEVIATION 172.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 40 Participants | 20 Participants | 20 Participants |
| Region of Enrollment Egypt | 40 participants | 20 participants | 20 participants |
| Sex: Female, Male Female | 22 Participants | 11 Participants | 11 Participants |
| Sex: Female, Male Male | 18 Participants | 9 Participants | 9 Participants |
| Spherical Equivalent Refractive Error Left Eye (SE/OS) | -0.22 diopter STANDARD_DEVIATION 1.68 | 0.1 diopter STANDARD_DEVIATION 0.89 | -0.55 diopter STANDARD_DEVIATION 2.18 |
| Spherical Equivalent Refractive Error Right Eye (SE/0D) | -0.22 diopter STANDARD_DEVIATION 1.08 | -0.03 diopter STANDARD_DEVIATION 0.74 | -0.41 diopter STANDARD_DEVIATION 1.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 8 / 20 | 5 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Ocular Alignment at Distant Fixation | 5.8 prism diopter | Standard Deviation 5.54 |
| Group 2 | Ocular Alignment at Distant Fixation | 1.1 prism diopter | Standard Deviation 4.7 |
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.
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Ocular Alignment at Near Fixation | 6.6 prism diopter | Standard Deviation 5.52 |
| Group 2 | Ocular Alignment at Near Fixation | 3.5 prism diopter | Standard Deviation 6.19 |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Sensory Status (Fusion) | positive fusion | 5 Participants |
| Group 1 | Sensory Status (Fusion) | absent fusion | 15 Participants |
| Group 2 | Sensory Status (Fusion) | positive fusion | 6 Participants |
| Group 2 | Sensory Status (Fusion) | absent fusion | 14 Participants |
Secondary
Sensory Status (Stereopsis)
ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc.
Time frame: one year
Population: Stereopsis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Sensory Status (Stereopsis) | 124 second of arc | Standard Deviation 81.3 |
| Group 2 | Sensory Status (Stereopsis) | 119.5 second of arc | Standard Deviation 54.2 |