Trial Outcomes & Findings for A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia (NCT NCT02223650)
NCT ID: NCT02223650
Last Updated: 2017-05-19
Results Overview
At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score\* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control. \*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.
COMPLETED
NA
58 participants
8 weeks
2017-05-19
Participant Flow
Between December 2014 and May 2015, 58 children were enrolled at 21 sites, with 31 participants assigned to observation and 27 to overminus treatment.
Participant milestones
| Measure |
Overminus Treatment
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
31
|
|
Overall Study
COMPLETED
|
27
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Baseline characteristics by cohort
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.2 years
STANDARD_DEVIATION 1 • n=5 Participants
|
5.1 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
5.1 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Age, Customized
3 to <4 years
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Age, Customized
4 to <5 years
|
4 participants
n=5 Participants
|
11 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Age, Customized
5 to <6 years
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Age, Customized
6 to <7 years
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Refractive error in more myopic eye (spherical equivalent, D)
>+0.50 to +1.00
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Refractive error in more myopic eye (spherical equivalent, D)
0 to +0.50
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Refractive error in more myopic eye (spherical equivalent, D)
<0 to >-0.50
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Refractive error in more myopic eye (spherical equivalent, D)
-0.50 to >-1.00
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Refractive error in more myopic eye (spherical equivalent, D)
-1.00 to >-1.50
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Refractive error in more myopic eye (spherical equivalent, D)
-1.50 to >-2.00
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Refractive error in more myopic eye (spherical equivalent, D)
-2.00 to >-2.50
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Refractive error in more myopic eye (spherical equivalent, D)
-2.50 to >-3.00
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Refractive error in more myopic eye (spherical equivalent, D)
<=-3.00
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Accommodative convergence over accommodation (AC/A) ratio
<2.5
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Accommodative convergence over accommodation (AC/A) ratio
2.5 to 6.0
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Accommodative convergence over accommodation (AC/A) ratio
>6.0
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksAt each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score\* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control. \*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Mean Distance Exotropia Control Score
|
2.0 points on control score scale
Standard Deviation 1.4
|
2.8 points on control score scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 8 weeksAt each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Mean Near Exotropia Control Score
|
0.9 points on control score scale
Standard Deviation 1.2
|
1.2 points on control score scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 8 weeksControl of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Distribution of Distance Control Score at 8-week Outcome
0 to <1
|
4 participants
|
1 participants
|
|
Distribution of Distance Control Score at 8-week Outcome
1 to <2
|
11 participants
|
7 participants
|
|
Distribution of Distance Control Score at 8-week Outcome
2 to <3
|
5 participants
|
10 participants
|
|
Distribution of Distance Control Score at 8-week Outcome
3 to <4
|
1 participants
|
3 participants
|
|
Distribution of Distance Control Score at 8-week Outcome
4 to 5
|
6 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 8 weeksControl of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Distribution of Near Control Score at 8-week Outcome
0 to <1
|
15 participants
|
10 participants
|
|
Distribution of Near Control Score at 8-week Outcome
1 to <2
|
7 participants
|
13 participants
|
|
Distribution of Near Control Score at 8-week Outcome
2 to <3
|
2 participants
|
3 participants
|
|
Distribution of Near Control Score at 8-week Outcome
3 to <4
|
2 participants
|
5 participants
|
|
Distribution of Near Control Score at 8-week Outcome
4 to 5
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 8 weeksA comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Proportion of Subjects With Distance Control Treatment Response
|
16 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).
A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=10 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
Looked over specatcles: Always
|
0 participants
|
0 participants
|
|
Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
Looked over specatcles: Often
|
3 participants
|
1 participants
|
|
Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
Looked over specatcles: Sometimes
|
7 participants
|
2 participants
|
|
Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
Looked over specatcles: Rarely
|
2 participants
|
2 participants
|
|
Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
Looked over specatcles: Never
|
15 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 8 weeksStereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Stereoacuity
|
2.2 log arcsecond
Standard Deviation 0.5
|
2.2 log arcsecond
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 8 weeksMonocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Distance Visual Acuity
|
21.1 prism diopters
Standard Deviation 11.2
|
23.0 prism diopters
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 8 weeksBinocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Binocular Near Visual Acuity
|
12.8 prism diopters
Standard Deviation 8.3
|
16.9 prism diopters
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 8 weeksA brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
Often
|
0 participants
|
0 participants
|
|
Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
Never
|
18 participants
|
24 participants
|
|
Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
Always
|
0 participants
|
0 participants
|
|
Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
Sometimes
|
4 participants
|
3 participants
|
|
Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
Rarely
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).
A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
Always
|
0 participants
|
0 participants
|
|
Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
Often
|
0 participants
|
0 participants
|
|
Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
Sometimes
|
1 participants
|
1 participants
|
|
Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
Rarely
|
0 participants
|
2 participants
|
|
Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
Never
|
26 participants
|
28 participants
|
SECONDARY outcome
Timeframe: 8 weeksA brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
Sometimes
|
1 participants
|
1 participants
|
|
Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
Rarely
|
1 participants
|
1 participants
|
|
Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
Always
|
0 participants
|
0 participants
|
|
Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
Often
|
0 participants
|
0 participants
|
|
Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
Never
|
25 participants
|
29 participants
|
SECONDARY outcome
Timeframe: 8 weeksA comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.
Outcome measures
| Measure |
Overminus Treatment
n=27 Participants
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 Participants
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Proportion of Subjects With Near Control Treatment Response
|
7 participants
|
8 participants
|
Adverse Events
Overminus Treatment
Non-overminus Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overminus Treatment
n=27 participants at risk
2.50D overminus spectacles
Overminus treatment: 2.50D overminus spectacles
|
Non-overminus Treatment
n=31 participants at risk
spectacles without overminus or no spectacles
Non-overminus treatment: spectacles without overminus or no spectacles
|
|---|---|---|
|
Eye disorders
Development of esodeviation
|
3.7%
1/27 • Number of events 1 • Baseline to 8 weeks after randomization.
|
0.00%
0/31 • Baseline to 8 weeks after randomization.
|
|
Eye disorders
Reduction in monocular distance visual acuity >=2 lines
|
7.4%
2/27 • Number of events 2 • Baseline to 8 weeks after randomization.
|
3.2%
1/31 • Number of events 1 • Baseline to 8 weeks after randomization.
|
|
Eye disorders
Reduction in binocular near visual acuity >=2 lines
|
0.00%
0/27 • Baseline to 8 weeks after randomization.
|
3.2%
1/31 • Number of events 1 • Baseline to 8 weeks after randomization.
|
Additional Information
Ray 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