Trial Outcomes & Findings for Symmetric vs Asymmetric BLR Recession in Management of Basic IXT With Ocular Dominance (NCT NCT05234957)
NCT ID: NCT05234957
Last Updated: 2024-12-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
one year
Results posted on
2024-12-10
Participant Flow
Participant milestones
| Measure |
Group 1
Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Symmetric vs Asymmetric BLR Recession in Management of Basic IXT With Ocular Dominance
Baseline characteristics by cohort
| Measure |
Group 1
n=20 Participants
Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.
|
Group 2
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.85 years
STANDARD_DEVIATION 5.42 • n=5 Participants
|
8.75 years
STANDARD_DEVIATION 5.48 • n=7 Participants
|
9.3 years
STANDARD_DEVIATION 5.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Best Corrected Visual Acuity Right Eye (BCVA/OD)
|
0.05 logMAR
STANDARD_DEVIATION 0.06 • n=5 Participants
|
0.02 logMAR
STANDARD_DEVIATION 0.06 • n=7 Participants
|
0.03 logMAR
STANDARD_DEVIATION 0.06 • n=5 Participants
|
|
Best Corrected Visual Acuity Left Eye (BCVA/OS)
|
0.06 logMAR
STANDARD_DEVIATION 0.09 • n=5 Participants
|
0.03 logMAR
STANDARD_DEVIATION 0.07 • n=7 Participants
|
0.05 logMAR
STANDARD_DEVIATION 0.08 • n=5 Participants
|
|
Spherical Equivalent Refractive Error Right Eye (SE/0D)
|
-0.03 diopter
STANDARD_DEVIATION 0.74 • n=5 Participants
|
-0.41 diopter
STANDARD_DEVIATION 1.3 • n=7 Participants
|
-0.22 diopter
STANDARD_DEVIATION 1.08 • n=5 Participants
|
|
Spherical Equivalent Refractive Error Left Eye (SE/OS)
|
0.1 diopter
STANDARD_DEVIATION 0.89 • n=5 Participants
|
-0.55 diopter
STANDARD_DEVIATION 2.18 • n=7 Participants
|
-0.22 diopter
STANDARD_DEVIATION 1.68 • n=5 Participants
|
|
Ocular Dominance Right Eye
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ocular Dominance Left Eye
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
preoperative distant deviation
|
36.25 prism diopter
STANDARD_DEVIATION 9.01 • n=5 Participants
|
32.25 prism diopter
STANDARD_DEVIATION 6.97 • n=7 Participants
|
34.25 prism diopter
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
preoperative near deviation
|
36.25 prism diopter
STANDARD_DEVIATION 10.1 • n=5 Participants
|
32.75 prism diopter
STANDARD_DEVIATION 7.51 • n=7 Participants
|
34.5 prism diopter
STANDARD_DEVIATION 8.97 • n=5 Participants
|
|
Fusion
positive fusion
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Fusion
absent fusion
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
preoperative stereopsis
|
251 second of arc
STANDARD_DEVIATION 171.4 • n=5 Participants
|
263 second of arc
STANDARD_DEVIATION 172.4 • n=7 Participants
|
257 second of arc
STANDARD_DEVIATION 169.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: one yearocular alignment in prism diopter (PD) at distant fixation (6 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.
Outcome measures
| Measure |
Group 1
n=20 Participants
Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.
|
Group 2
n=20 Participants
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.
|
|---|---|---|
|
Ocular Alignment at Distant Fixation
|
5.8 prism diopter
Standard Deviation 5.54
|
1.1 prism diopter
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: one yearocular 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.
Outcome measures
| Measure |
Group 1
n=20 Participants
Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.
|
Group 2
n=20 Participants
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.
|
|---|---|---|
|
Ocular Alignment at Near Fixation
|
6.6 prism diopter
Standard Deviation 5.52
|
3.5 prism diopter
Standard Deviation 6.19
|
SECONDARY outcome
Timeframe: one yearPopulation: Stereopsis
ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc.
Outcome measures
| Measure |
Group 1
n=20 Participants
Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.
|
Group 2
n=20 Participants
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.
|
|---|---|---|
|
Sensory Status (Stereopsis)
|
124 second of arc
Standard Deviation 81.3
|
119.5 second of arc
Standard Deviation 54.2
|
SECONDARY outcome
Timeframe: one yearFusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion).
Outcome measures
| Measure |
Group 1
n=20 Participants
Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.
|
Group 2
n=20 Participants
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.
|
|---|---|---|
|
Sensory Status (Fusion)
positive fusion
|
5 Participants
|
6 Participants
|
|
Sensory Status (Fusion)
absent fusion
|
15 Participants
|
14 Participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=20 participants at risk
Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.
|
Group 2
n=20 participants at risk
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.
|
|---|---|---|
|
Eye disorders
undercorrection/recurrence
|
40.0%
8/20 • 1 year
|
20.0%
4/20 • 1 year
|
|
Eye disorders
overcorrection
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place