| Primary | Exotropia Control Score at Distance, Continuous Score | The primary analysis will be an intent-to-treat comparison of mean 8-week control of the distance exodeviation (average of 3 measurements) between treatment groups using an analysis of covariance (ANCOVA) model, which adjusts for baseline distance control. Distance control scores range from 0 to 5 with higher scores indicating a worse outcome. | | Posted | | Mean | Standard Deviation | units on a scale | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0003.6± 1.3
- OG0013.3± 1.5
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The primary analysis was the treatment group difference (and 95% CI) in mean distance control at the 8-week outcome visit using an ANCOVA adjusted for baseline distance control. The planned convenience sample size of 64 was expected to provide outcome data for at least 60 participants (30 per group). | | | | | Mean Difference (Final Values) | 0.3 | | | 2-Sided | 95 | -0.5 | 1.1 | | | Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group). | | |
|
| Secondary | Exotropia Control Score at Distance, % With Treatment Response | The secondary analysis will calculate the percentage of participants with a "treatment response," defined as ≥1 point improvement in control of their distance exodeviation (average of 3 measurements) between baseline and the 8-week outcome exam. | | Posted | | Number | | percentage of participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Exotropia Control Score at Distance and Near, % With No Spontaneous Tropia | The proportion of participants with no spontaneous tropia at 8 weeks will be compared between treatment groups using a two-sided Barnard's test with alpha of 0.05, with calculation of a two-sided 95% confidence interval on the difference in proportions. No spontaneous tropia at the 8-week primary outcome exam is defined as a score of ≤2 (0, 1, or 2) on all three assessments of control at distance and at near. | | Posted | | Number | | percentage of participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Exotropia Control Score at Distance, Continuous Change Between Baseline and 8 Weeks | Control of the exodeviation was measured at distance using the IXT Office Control Score, (Mohney, 2006) which ranges from 0 (phoria) to 5 (constant exotropia). Control levels 3-5 were assigned based on the duration of manifest exotropia during a 30-second period before any dissociation. If no exotropia was observed, control levels 0-2 were assigned based on the longest time to reestablishing fusion after 3 consecutive 10-second periods of dissociation. Control was measured at the beginning, middle, and end (3 tests) of a 20- to 40-minute office examination, and the mean was used. The change in distance control from baseline to 8 weeks will be calculated. A negative value indicates improvement. | | Posted | | Mean | Standard Deviation | units on a scale | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
|
| Secondary | Exotropia Control Score at Near, Continuous Score | Near control will be evaluated similarly to the primary outcome and outcome measures 2-4. Near control scores range from 0 to 5 with higher scores indicating a worse outcome. | | Posted | | Mean | Standard Deviation | units on a scale | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Exodeviation by PACT at Distance, Continuous | The measure of ocular alignment at distance by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse. | | Posted | | Mean | Standard Deviation | prism diopters | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Exodeviation by PACT at Near, Continuous | The measure of ocular alignment at near by PACT will be summarized at 8 weeks for each treatment group. A higher deviation is worse. | | Posted | | Mean | Standard Deviation | prism diopters | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Randot Preschool Stereoacuity at Near, Continuous | Randot® Preschool Stereoacuity test (Stereo Optical Co., Inc., Chicago, IL). For analysis, stereoacuity was converted from seconds of arc scores to log arcsec values (in parentheses) as follows: 40 (1.60), 60 (1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90); participants with no detectable (nil) stereoacuity were assigned the value of 1600 (3.20). The measure of Randot Preschool Stereoacuity at near will be summarized at 8 weeks for each treatment group. A lower score is better. | | Posted | | Mean | Standard Deviation | log arc seconds | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Compliance of Spectacle Wear | Parents will be asked to complete a compliance calendar by recording the percentage of time their child has worn the study-prescribed spectacle correction each day. Proportion of time worn each day will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), poor (1 to 25%), or none (0%). Based on review of the calendars and discussion with parents at the 8-week outcome exam, the investigator will record the total proportion of time worn as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), poor (1 to 25%), or none (0%: did not fill prescription or never picked up spectacles). The distribution of compliance will be assessed for each treatment group at the outcome exam. | | Posted | | Count of Participants | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
|
| Secondary | Child Assessment of Symptoms - Do Your Eyes Hurt? | Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Child Assessment of Symptoms - Do Your Eyes Feel Funny? | Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Child Assessment of Symptoms - Do You Have Double Vision? | Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Child Assessment of Symptoms - Is it Hard for You to Stare at Things? | Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Child Assessment of Symptoms - Do You Have Problems With Your Eyes in the Sun? | Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Child Assessment of Symptoms - Do Your Eyes go in and Out? | Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Child Assessment of Symptoms - Is it Hard to Focus Your Eyes? | Adverse symptoms of intermittent exotropia will be summarized at the 8-week outcome exam using a symptom survey that is administered to the child. Response options are based on frequency of observations: never, sometimes, and always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Headaches? | Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Had Eyestrain? | Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Avoided Reading or Doing Things up Close? | Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Reported Blurry Vision? | Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Looked Over His or Her Spectacles? | Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Taken His/Her Spectacles Off When he/She Should be Wearing Them? | Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Secondary | Parent Assessment of Symptoms and Spectacle Wear - Has Your Child Complained That the Spectacles Hurt His/Her Ears and/or Nose? | Adverse symptoms of intermittent exotropia and spectacle wear will be summarized at the 8-week outcome exam using a symptom survey that is administered to the parent. Response options are based on frequency of observations: never, almost never, sometimes, often, and almost always. The distribution of scores on each survey item will be tabulated by treatment group after 8-weeks. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Other Pre-specified | Distance Visual Acuity (Snellen Equivalent) | Distance visual acuity will be assessed at the 8-week outcome exam. Any optotype method can be used for testing. The distribution of distance visual acuity Snellen Equivalents will be tabulated for each treatment group. A lower Snellen Equivalent is best. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Other Pre-specified | Fusional Convergence - Continuous Break Point | As an exploratory analysis, the distribution of fusional convergence amplitude (break point, blur point, and recovery) at 8 weeks will be summarized for each treatment group. Fusional amplitudes are a measure of how well a participant can converge their eyes using fusional vergence. It is measured by increasing base-out prism to the point that the participant is no longer able to control the deviation. The total amount of fusion is the magnitude of the base-out prism the participant was able to overcome plus the magnitude of the deviation. A higher number of prism diopters for break point is better than a lower number. A lower number for recovery point is better than a higher number. | 3 participants in the Prism group and 2 participants in the Non-Prism group were unable to perform testing at 8 weeks and are not included. | Posted | | Mean | Standard Deviation | prism diopters | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
|
| Other Pre-specified | Suppression | The suppression assessment is a standardized method of assessing the depth of suppression experienced while the participant is tropic (NOT aligned). Scoring is reported on an ordinal scale from 0 (no suppression) to 3 (dense suppression). "Missing" refers to cases in which participants were unable to understand the test and/or gave unreliable responses. As an exploratory analysis, the distribution of suppression level (none, mild, moderate, severe, missing) will be tabulated after 8 weeks by treatment group. | | Posted | | Count of Participants | | Participants | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
| |
| Other Pre-specified | Fusional Convergence - Continuous Recovery Point | As an exploratory analysis, the distribution of fusional convergence amplitude (break point, blur point, and recovery) at 8 weeks will be summarized for each treatment group. Fusional amplitudes are a measure of how well a participant can converge their eyes using fusional vergence. It is measured by increasing base-out prism to the point that the participant is no longer able to control the deviation. The total amount of fusion is the magnitude of the base-out prism the participant was able to overcome plus the magnitude of the deviation. A higher number of prism diopters for break point is better than a lower number. A lower number for recovery is better than a higher number. | 3 participants in the Prism group and 2 participants in the Non-Prism group were unable to perform testing at 8 weeks and are not included. | Posted | | Mean | Standard Deviation | prism diopters | | 8 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Prism Group | Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by prism and alternate cover test (PACT) at distance or near) equally divided between the 2 lenses will be prescribed to the participant Prism Glasses: Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses | | OG001 | Non-Prism Group | Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism will be prescribed to the participant Non-Prism Glasses: Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism |
|