Trial Outcomes & Findings for Bilateral Lateral Rectus Recession Versus Unilateral Recess-Resect for Intermittent Exotropia (NCT NCT01032603)
NCT ID: NCT01032603
Last Updated: 2024-02-07
Results Overview
A participant's intermittent exotropia (IXT) was considered to be a suboptimal surgical outcome if at any visit occurring 6 months or later, ANY of the following criteria are present by masked examiner testing: 1. Exotropia at distance OR near at any time during the exam (i.e., can be constant or intermittent; determined by a cover/uncover test) with a magnitude of ≥10Δ by SPCT, confirmed by a retest 2. Constant esotropia at distance OR near (determined by at least 3 cover/uncover tests-one must be before any dissociation) with a magnitude of ≥6Δ by SPCT, confirmed by a retest 3. Decrease in Randot Preschool near stereoacuity ≥2 octaves (≥0.6 log arcsec) from enrollment, or to nil, confirmed by a retest Participants who underwent reoperation (or treatment with botulinum toxin) without first meeting any of the above suboptimal surgical outcome criteria were also counted as suboptimal surgical outcomes in the primary analysis.
COMPLETED
NA
197 participants
3 years
2024-02-07
Participant Flow
Participant milestones
| Measure |
Bilateral Lateral Rectus Recession
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
96
|
|
Overall Study
COMPLETED
|
86
|
77
|
|
Overall Study
NOT COMPLETED
|
15
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bilateral Lateral Rectus Recession Versus Unilateral Recess-Resect for Intermittent Exotropia
Baseline characteristics by cohort
| Measure |
Bilateral Lateral Rectus Recession
n=101 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=96 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
101 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.4 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
5.9 Years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
6.2 Years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Age, Customized
3 to <4 years old
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Customized
4 to <5 years old
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Customized
5 to <6 years old
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Customized
6 to <7 years old
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Customized
7 to <8 years old
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Customized
8 to <9 years old
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Customized
9 to <10 years old
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Customized
10 to <11 years old
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Prior Nonsurgical Treatment
No treatment
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Prior Nonsurgical Treatment
Patching alone
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Prior Nonsurgical Treatment
Overminus spectacles alone
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Prior Nonsurgical Treatment
Vision therapy alone
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Prior Nonsurgical Treatment
Combination or other
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity
40 Arcsec
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity
60 Arcsec
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity
100 Arcsec
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity
200 Arcsec
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity
400 Arcsec
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Randot Preschool Stereoacuity (log arcsec)
|
2.1 logarithm of seconds of arc (log arcsec)
n=5 Participants
|
2.0 logarithm of seconds of arc (log arcsec)
n=7 Participants
|
2.1 logarithm of seconds of arc (log arcsec)
n=5 Participants
|
|
Distance Randot Stereoacuity
60 Arcsec
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Distance Randot Stereoacuity
100 Arcsec
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Distance Randot Stereoacuity
200 Arcsec
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Distance Randot Stereoacuity
400 Arcsec
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Distance Randot Stereoacuity
Nil
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Distance Randot Stereoacuity
Missing
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Distance Randot Stereoacuity (log arcsec)
|
2.3 log arcsec
n=5 Participants
|
2.3 log arcsec
n=7 Participants
|
2.3 log arcsec
n=5 Participants
|
|
Baseline Exotropia Magnitude by PACT at Distance
|
26 Prism Diopter
STANDARD_DEVIATION 6 • n=5 Participants
|
26 Prism Diopter
STANDARD_DEVIATION 6 • n=7 Participants
|
26 Prism Diopter
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Baseline Exotropia Magnitude by PACT at Near
|
25 Prism Diopter
STANDARD_DEVIATION 8 • n=5 Participants
|
24 Prism Diopter
STANDARD_DEVIATION 8 • n=7 Participants
|
24 Prism Diopter
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Baseline Exotropia Control at Distance
|
3.4 scores on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
3.4 scores on a scale
STANDARD_DEVIATION 1.2 • n=7 Participants
|
3.4 scores on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Baseline Exotropia Control at Near
|
1.9 scores on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
1.7 scores on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
|
1.8 scores on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsA participant's intermittent exotropia (IXT) was considered to be a suboptimal surgical outcome if at any visit occurring 6 months or later, ANY of the following criteria are present by masked examiner testing: 1. Exotropia at distance OR near at any time during the exam (i.e., can be constant or intermittent; determined by a cover/uncover test) with a magnitude of ≥10Δ by SPCT, confirmed by a retest 2. Constant esotropia at distance OR near (determined by at least 3 cover/uncover tests-one must be before any dissociation) with a magnitude of ≥6Δ by SPCT, confirmed by a retest 3. Decrease in Randot Preschool near stereoacuity ≥2 octaves (≥0.6 log arcsec) from enrollment, or to nil, confirmed by a retest Participants who underwent reoperation (or treatment with botulinum toxin) without first meeting any of the above suboptimal surgical outcome criteria were also counted as suboptimal surgical outcomes in the primary analysis.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=101 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=96 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Number of Participants With Suboptimal Surgical Outcome as Assessed by Motor Alignment and Stereoacuity at Near by 3 Years
|
43 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 3 yearsExotropia ≥10Δ by simultaneous prism and cover test (SPCT) at distance or near, confirmed by a retest, by 3 years. Criteria was met before any reoperation, and regardless of whether suboptimal surgical outcome was met by another criteria.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=101 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=96 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Patients With Exotropia by 3 Years
|
31 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 3 yearsConstant esotropia ≥6Δ by simultaneous prism and cover test (SPCT) at distance or near, confirmed by a retest, by 3 years. Criteria was met before any reoperation, and regardless of whether suboptimal surgical outcome was met by another criteria.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=101 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=96 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Patients With Constant Esotropia by 3 Years
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 3 yearsDecrease in Preschool Randot near stereoacuity ≥2 octaves (≥0.6 log arcsec) from enrollment, or to nil, confirmed by a retest, by 3 years. Criteria was met before any reoperation, and regardless of whether suboptimal surgical outcome was met by another criteria.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=101 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=96 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Number of Participants With Stereo Loss by 3 Years
|
13 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: Includes only patients who completed the 3-year visit.
Exotropia control at distance was assessed in all patients who completed the 3-year visit. Numeric values for exotropia control were assigned so that the following seven categories were created: Not applicable (no exodeviation) (0) No exotropia unless dissociated, recovers \<1 secs (phoria) 1. No exotropia unless dissociated, recovers 1-5 secs 2. No exotropia unless dissociated, recovers \>5 secs 3. Exotropia \<50% of 30-second observation 4. Exotropia \>50% of 30-second observation 5. Constant exotropia
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Number of Participants With Exotropia Control at Distance at 3 Years
Not applicable (no exodeviation)
|
19 Participants
|
25 Participants
|
|
Number of Participants With Exotropia Control at Distance at 3 Years
(0) No exotropia unless dissociated, recovers <1 s
|
25 Participants
|
22 Participants
|
|
Number of Participants With Exotropia Control at Distance at 3 Years
(1) No exotropia unless dissociated, recovers 1-5
|
14 Participants
|
11 Participants
|
|
Number of Participants With Exotropia Control at Distance at 3 Years
(2) No exotropia unless dissociated, recovers >5 s
|
12 Participants
|
6 Participants
|
|
Number of Participants With Exotropia Control at Distance at 3 Years
(3) Exotropia <50% of 30-second observation
|
5 Participants
|
4 Participants
|
|
Number of Participants With Exotropia Control at Distance at 3 Years
(4) Exotropia >50% of 30-second observation
|
6 Participants
|
4 Participants
|
|
Number of Participants With Exotropia Control at Distance at 3 Years
(5) Constant exotropia
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: Range of the mean was 0 to 5 for both the BLR group and for the RR group.
Mean exotropia control at distance was assessed in all patients who completed the 3-year visit. All 3-year visit data will be analyzed regardless of what treatment(s) a patient has received and regardless of whether the patient has undergone reoperation. Control at distance was analyzed as a continuous variable and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year distance control will adjust for baseline distance control). Numeric values for exotropia control were assigned so that the following categories were created: Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers \<1 secs (phoria) 1. No exotropia unless dissociated, recovers 1-5 secs 2. No exotropia unless dissociated, recovers \>5 secs 3. Exotropia \<50% of 30-second observation 4. Exotropia \>50% of 30-second observation 5. Constant exotropia Lower scores indicate better control.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Mean Distance Control at 3 Years
|
1.2 score on a scale
Standard Deviation 1.6
|
1.0 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Enrollment to 3 yearsPopulation: Range of the mean was -3 to 5 for the BLR group and -2 to 5 for the RR group.
Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement. Numeric values for exotropia control were assigned so that the following categories were created: Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers \<1 secs (phoria) 1. No exotropia unless dissociated, recovers 1-5 secs 2. No exotropia unless dissociated, recovers \>5 secs 3. Exotropia \<50% of 30-second observation 4. Exotropia \>50% of 30-second observation 5. Constant exotropia Lower scores indicate better control.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Change in Distance Exotropia Control at 3 Years
|
2.3 score on a scale
Standard Deviation 1.7
|
2.5 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: Includes only patients who completed the 3-year visit.
Exotropia control at near was assessed in all patients who completed the 3-year visit. Numeric values for exotropia control were assigned so that the following categories were created: Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers \<1 secs (phoria) 1. No exotropia unless dissociated, recovers 1-5 secs 2. No exotropia unless dissociated, recovers \>5 secs 3. Exotropia \<50% of 30-second observation 4. Exotropia \>50% of 30-second observation 5. Constant exotropia Lower scores indicate better control.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Number of Participants With Exotropia Control at Near at 3 Years
Not applicable (no exodeviation)
|
20 Participants
|
21 Participants
|
|
Number of Participants With Exotropia Control at Near at 3 Years
(0) No exotropia unless dissociated, recovers <1 s
|
36 Participants
|
32 Participants
|
|
Number of Participants With Exotropia Control at Near at 3 Years
(1) No exotropia unless dissociated, recovers 1-5
|
16 Participants
|
13 Participants
|
|
Number of Participants With Exotropia Control at Near at 3 Years
(2) No exotropia unless dissociated, recovers >5 s
|
6 Participants
|
4 Participants
|
|
Number of Participants With Exotropia Control at Near at 3 Years
(3) Exotropia <50% of 30-second observation
|
1 Participants
|
4 Participants
|
|
Number of Participants With Exotropia Control at Near at 3 Years
(4) Exotropia >50% of 30-second observation
|
6 Participants
|
3 Participants
|
|
Number of Participants With Exotropia Control at Near at 3 Years
(5) Constant exotropia
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: Range of the mean was 0 to 5 for the BLR group and 0 to 4 for the RR group.
Mean exotropia control at near was assessed in all patients who completed the 3-year visit. All 3-year visit data will be analyzed regardless of what treatment(s) a patient has received and regardless of whether the patient has undergone reoperation. Control at near was analyzed as a continuous variable and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year near control will adjust for baseline near control). Numeric values for exotropia control were assigned so that the following categories were created: Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers \<1 secs (phoria) 1. No exotropia unless dissociated, recovers 1-5 secs 2. No exotropia unless dissociated, recovers \>5 secs 3. Exotropia \<50% of 30-second observation 4. Exotropia \>50% of 30-second observation 5. Constant exotropia Lower scores indicate better control.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Mean Near Control at 3 Years
|
0.7 score on a scale
Standard Deviation 1.2
|
0.6 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Enrollment to 3 YearsPopulation: Range of the mean was -3 to 4 for both the BLR and RR groups.
Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement. Numeric values for exotropia control were assigned so that the following categories were created: Not applicable (no exodeviation) 0: No exotropia unless dissociated, recovers \<1 secs (phoria) 1. No exotropia unless dissociated, recovers 1-5 secs 2. No exotropia unless dissociated, recovers \>5 secs 3. Exotropia \<50% of 30-second observation 4. Exotropia \>50% of 30-second observation 5. Constant exotropia Lower scores indicate better control.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Change in Near Exotropia Control at 3 Years
|
1.3 score on a scale
Standard Deviation 1.6
|
1.1 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 3 years after enrollmentThe prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. PACT was assessed in all patients who completed the 3-year visit. ∆ = prism diopters; eso = esodeviation; exo = exodeviation
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Number of Participants With Distance PACT at 3 Years
40-45∆ Exo
|
0 Participants
|
0 Participants
|
|
Number of Participants With Distance PACT at 3 Years
No Deviation
|
10 Participants
|
21 Participants
|
|
Number of Participants With Distance PACT at 3 Years
1-9∆ Exo
|
23 Participants
|
17 Participants
|
|
Number of Participants With Distance PACT at 3 Years
10-14∆ Exo
|
15 Participants
|
12 Participants
|
|
Number of Participants With Distance PACT at 3 Years
15-18∆ Exo
|
10 Participants
|
7 Participants
|
|
Number of Participants With Distance PACT at 3 Years
20-25∆ Exo
|
16 Participants
|
12 Participants
|
|
Number of Participants With Distance PACT at 3 Years
30-35∆ Exo
|
3 Participants
|
2 Participants
|
|
Number of Participants With Distance PACT at 3 Years
10-14∆ Eso
|
2 Participants
|
0 Participants
|
|
Number of Participants With Distance PACT at 3 Years
1-9∆ Eso
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: Range of the mean was -14 to 35 for the BLR group and -6 to 30 for the RR group.
The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. Mean PACT was assessed in all patients who completed the 3-year visit. All 3-year visit data will be analyzed regardless of what treatment(s) a patient has received and regardless of whether the patient has undergone reoperation. PACT was analyzed as a continuous variable and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year PACT at distance will adjust for baseline PACT at distance).
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Mean Distance PACT at 3 Years
|
10 prism diopters
Standard Deviation 10
|
9 prism diopters
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Enrollment to 3 yearsPopulation: Range of the mean was -10 to 44 for the BLR group and -5 to 36 for the RR group.
The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement. If the 3-year PACT is an esodeviation, change in PACT from baseline is the reduction in the exodeviation plus the amount of the 3-year exodeviation.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Change in Distance PACT From Baseline to 3 Years
|
16 prism diopters
Standard Deviation 11
|
18 prism diopters
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 3 years after enrollmentThe prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. PACT was assessed in all patients who completed the 3-year visit. ∆ = prism diopters; eso = esodeviation; exo = exodeviation
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Number of Participants With Near PACT at 3 Years
No Deviation
|
11 Participants
|
15 Participants
|
|
Number of Participants With Near PACT at 3 Years
1-9∆ Exo
|
21 Participants
|
24 Participants
|
|
Number of Participants With Near PACT at 3 Years
10-14∆ Exo
|
16 Participants
|
9 Participants
|
|
Number of Participants With Near PACT at 3 Years
15-18∆ Exo
|
11 Participants
|
5 Participants
|
|
Number of Participants With Near PACT at 3 Years
20-25∆ Exo
|
13 Participants
|
14 Participants
|
|
Number of Participants With Near PACT at 3 Years
30-35∆ Exo
|
3 Participants
|
3 Participants
|
|
Number of Participants With Near PACT at 3 Years
40-45∆ Exo
|
1 Participants
|
0 Participants
|
|
Number of Participants With Near PACT at 3 Years
10-14∆ Eso
|
1 Participants
|
0 Participants
|
|
Number of Participants With Near PACT at 3 Years
1-9∆ Eso
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: Range of the mean was -14 to 40 for the BLR group and -6 to 30 for the RR group.
The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. Mean PACT was assessed in all patients who completed the 3-year visit. All 3-year visit data will be analyzed regardless of what treatment(s) a patient has received and regardless of whether the patient has undergone reoperation. PACT was analyzed as a continuous variable and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year PACT at near will adjust for baseline PACT at near).
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Mean Near PACT at 3 Years
|
10 prism diopters
Standard Deviation 11
|
9 prism diopters
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Enrollment to 3 yearsPopulation: Range of the mean was -14 to 44 for the BLR group and -12 to 41 for the RR group.
The prism and alternate cover test (PACT) is used to measure the angle of strabismus, or deviation, in prism diopters. This is measured separately at distance and at near. Smaller numbers are better because they indicate a smaller angle of deviation. Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement. If the 3-year PACT is an esodeviation, change in PACT from baseline is the reduction in the exodeviation plus the amount of the 3-year exodeviation.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Change in Near PACT From Baseline to 3 Years
|
15 prism diopters
Standard Deviation 12
|
16 prism diopters
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: Includes only patients who completed the 3-year visit.
Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. Stereoacuity Testing: stereoacuity was assessed in current refractive correction using the following: Preschool Randot stereotest at near (performed at 40 cm): If stereoacuity is worse than 40 arcsec, it must be retested and the better of the 2 measurements will be used for eligibility. Distance Randot stereotest (performed at 3 meters)
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Participants With Near Stereoacuity Measures at 3 Years
200
|
3 Participants
|
4 Participants
|
|
Participants With Near Stereoacuity Measures at 3 Years
800
|
1 Participants
|
1 Participants
|
|
Participants With Near Stereoacuity Measures at 3 Years
40
|
34 Participants
|
37 Participants
|
|
Participants With Near Stereoacuity Measures at 3 Years
60
|
23 Participants
|
17 Participants
|
|
Participants With Near Stereoacuity Measures at 3 Years
100
|
19 Participants
|
12 Participants
|
|
Participants With Near Stereoacuity Measures at 3 Years
400
|
4 Participants
|
4 Participants
|
|
Participants With Near Stereoacuity Measures at 3 Years
Nil
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: The range of the mean was -1.6 to 3.2 for both the BLR and RR groups.
Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Stereoacuity Testing: stereoacuity was assessed in current refractive correction using the following: Preschool Randot stereotest at near (performed at 40 cm): If stereoacuity is worse than 40 arcsec, it must be retested and the better of the 2 measurements will be used for eligibility. Distance Randot stereotest (performed at 3 meters)
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Mean Near Stereoacuity at 3 Years
|
1.9 logarithm of seconds of arc (log arcsec)
Standard Deviation 0.3
|
1.8 logarithm of seconds of arc (log arcsec)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Enrollment to 3 yearsPopulation: Range of the mean was -1.3 to 1.0 for the BLR group and -1.4 to 1.0 for the RR group.
Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Change in Near Stereoacuity From Baseline to 3 Years
|
0.2 logarithm of seconds of arc (log arcsec)
Standard Deviation 0.4
|
0.2 logarithm of seconds of arc (log arcsec)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 3 years after enrollmentStereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. Stereoacuity Testing: stereoacuity was assessed in current refractive correction using the following: Preschool Randot stereotest at near (performed at 40 cm): If stereoacuity is worse than 40 arcsec, it must be retested and the better of the 2 measurements will be used for eligibility. Distance Randot stereotest (performed at 3 meters)
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Participants Distance Stereoacuity at 3 Years
60
|
30 Participants
|
35 Participants
|
|
Participants Distance Stereoacuity at 3 Years
100
|
17 Participants
|
7 Participants
|
|
Participants Distance Stereoacuity at 3 Years
200
|
20 Participants
|
14 Participants
|
|
Participants Distance Stereoacuity at 3 Years
400
|
7 Participants
|
10 Participants
|
|
Participants Distance Stereoacuity at 3 Years
Nil
|
12 Participants
|
10 Participants
|
|
Participants Distance Stereoacuity at 3 Years
Missing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: Range of the mean was 1.8 to 2.9 for both the BLR and RR groups.
Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Stereoacuity Testing: stereoacuity was assessed in current refractive correction using the following: Preschool Randot stereotest at near (performed at 40 cm): If stereoacuity is worse than 40 arcsec, it must be retested and the better of the 2 measurements will be used for eligibility. Distance Randot stereotest (performed at 3 meters)
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Mean Distance Stereoacuity at 3 Years
|
2.2 logarithm of seconds of arc (log arcsec
Standard Deviation 0.4
|
2.2 logarithm of seconds of arc (log arcsec
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Enrollment to 3 yearsPopulation: Range of the mean was -0.9 to 1.1 for the BLR group and -0.8 to 1.1 for the RR group.
Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Change is defined as the baseline value minus the 3-year value, therefore positive change = improvement.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Change in Distance Stereoacuity From Baseline to 3 Years
|
0.1 logarithm of seconds of arc (log arcsec)
Standard Deviation 0.4
|
0.1 logarithm of seconds of arc (log arcsec)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: The total number of children/patients was split between two categories: younger and older, which is why the number analyzed is different between rows. 1 patient in the BLR group and 2 patients in the RR group were missing quality of life questionnaire data. Parent information was not missing which is why the total number is equal to number analyzed
Health-related quality of life will be assessed using the Intermittent Exotropia Questionnaire (IXTQ). This questionnaire consists of 6 components: 1. Child questionnaire - consists of 12 items which assess how the child feels about his/her eye condition. * One version for children aged 5 to \< 8 years has a 3-level response scale * The version for children aged 8 years and older has a 5-level response scale 2. Parent proxy questionnaire - consists of 12 items which assess how the parent feels the child's eye condition affects the child 3. Parental questionnaire - consists of 17 items which assess how the child's eye condition affects the parent. Has 3 sub-scales: surgical, functional, and psycho-social. All scales ranged from 0 to 100; higher values indicated a better quality of life. Sub-scales were not combined, but rather were each evaluated individually on a scale of 0-100.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Health Related Quality of Life
Child 5 to 7 years old IXTQ
|
91 score on a scale
Interval 0.0 to 100.0
|
86 score on a scale
Interval 0.0 to 100.0
|
|
Health Related Quality of Life
Child 8 to 13 years old IXTQ
|
82 score on a scale
Interval 0.0 to 100.0
|
82 score on a scale
Interval 0.0 to 100.0
|
|
Health Related Quality of Life
Parent Proxy IXTQ
|
86 score on a scale
Interval 0.0 to 100.0
|
91 score on a scale
Interval 0.0 to 100.0
|
|
Health Related Quality of Life
Parent Psychosocial
|
97 score on a scale
Interval 0.0 to 100.0
|
100 score on a scale
Interval 0.0 to 100.0
|
|
Health Related Quality of Life
Parent Function
|
83 score on a scale
Interval 0.0 to 100.0
|
86 score on a scale
Interval 0.0 to 100.0
|
|
Health Related Quality of Life
Parent Surgery
|
83 score on a scale
Interval 0.0 to 100.0
|
92 score on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 years after enrollmentThe cumulative proportion of re-operation by 3 years was compared between treatment groups using methods similar to the primary analysis (i.e. using Kaplan-Meier method). A treatment-group difference and a corresponding 95% confidence interval were also calculated. Reasons for re-operation included: XT; XT and worsening stereo ; XT, worsening stereo and social concerns ; XT, diplopia, and headaches ; XT and squinting with one eye closed ; ET ; ET, worsening stereo, and diplopia; ET, worsening stereo and social concerns ; ET, worsening stereo, social concerns, and amblyopia ; Inferior oblique overaction
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=101 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=96 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Cumulative Number of Patients With Reoperation by 3 Years
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: Includes only those patients that completed the 3-year visit.
Complete or near-complete resolution was defined as meeting all of the following at the 3 year visit: 1) exodeviation \<10 Δ (tropia or phoria) by both SPCT and PACT at distance and near and ≥10 Δ reduction in PACT magnitude from the largest of the distance and near angles at enrollment, 2) esotropia \<6 Δ at distance and near by SPCT, 3) no decrease in Randot Preschool stereoacuity of ≥2 octaves from the enrollment stereoacuity or to nil, 4) no reoperation or treatment with botulinum toxin, and 5) no non-surgical treatment for a recurrent or residual exodeviation.
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Number of Participants With Complete or Near-Complete Resolution at 3 Years
|
26 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 3 years after enrollmentPopulation: Includes only those who completed the 3 year visit.
Suboptimal surgical outcome at the 3-year visit was defined as meeting any of the three suboptimal surgical outcome criteria at the 3-year visit (regardless of whether the criterion had been met at an earlier visit), or undergoing reoperation at any time. The three criteria for suboptimal surgical outcome were: 1. Exotropia at distance OR near at any time during the exam (i.e., can be constant or intermittent; determined by a cover/uncover test) with a magnitude of ≥10Δ by SPCT, confirmed by a retest 2. Constant esotropia at distance OR near (determined by at least 3 cover/uncover tests-one must be before any dissociation) with a magnitude of ≥6Δ by SPCT, confirmed by a retest 3. Decrease in Randot Preschool near stereoacuity ≥2 octaves (≥0.6 log arcsec) from enrollment, or to nil, confirmed by a retest
Outcome measures
| Measure |
Bilateral Lateral Rectus Recession
n=86 Participants
Bilateral lateral rectus recession surgery
Bilateral lateral rectus recession (BLRc): Bilateral lateral rectus recession surgery
|
Unilateral Lateral Rectus Recession
n=77 Participants
Unilateral lateral rectus recession w/ medial rectus resection surgery
Unilateral lateral rectus recession with medial rectus resection (R\&R): A unilateral lateral rectus recession combined with a medial rectus resection in the same eye. Choice of eye at investigator discretion based on any interocular difference, position under anesthesia, fixation preference, or forced duction testing. Reason for choice of eye will be recorded.
|
|---|---|---|
|
Participants Suboptimal Surgical Outcome at 3 Years
|
25 Participants
|
13 Participants
|
Adverse Events
Bilateral Lateral Rectus Recession
Unilateral Lateral Rectus Recession
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center
Jaeb Center for Health Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place