AmblyopiaPhase 3ATS16NCT00944710
Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
A Phase 3 study testing Atropine and Plano lens in people with Amblyopia, run by Jaeb Center for Health Research at 2 sites in United States.
Trial summary
This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Atropine and Plano lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Major Eligibility Criteria for Run-in Phase
- Age 3 to < 8 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
- Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines
- Amblyopia treatment within the past 6 months subject to the following stipulations:
Show all 17Show fewer
- No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with atropine who are entering the study on treatment)
- No simultaneous treatment with patching and atropine
- No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
- Maximum level of treatment within the past 6 months:
- Patching: up to 2 hours daily
- Atropine: up to once daily
- Wearing spectacles with optimal correction (if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses; if amblyopic eye acuity is 20/100 or worse, then spectacles and atropine can be initiated simultaneously).
- Hypermetropia and spectacle correction in sound eye of +1.50 D or more
- Eligibility Criteria for Randomization:
- Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.
- Compliance with weekend atropine treatment based on investigator judgment.
Who cannot join
- Currently using vision therapy or orthoptics
- Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
- Prior intraocular or refractive surgery
- Known allergy to atropine or other cycloplegic drugs
- Down Syndrome present
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Eye Center
Durham, North Carolina, 27710
Southern California College of Optometry
Fullerton, California, 92831
About this study
This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.
Read the detailed description
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children.1 Many practitioners prescribe weekend atropine as initial therapy for amblyopia. However, many children fail to achieve normal visual acuity in the amblyopic eye after treatment with this regimen. In a randomized trial conducted by PEDIG comparing atropine regimens, 58 of 83 patients with moderate amblyopia (70%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of treatment with weekend atropine.2 In another PEDIG randomized trial comparing atropine with a plano lens versus without a plano lens for initial treatment of amblyopia, 60 of 84 patients with moderate amblyopia (71%) had amblyopic eye visual acuity of 20/32 or worse after 16 weeks of treatment with weekend atropine.3 When improvement stops after initial therapy and amblyopia is still present, treatment options include increasing the dosage of current treatment, switching to another treatment, maintaining the same treatment and dosage, or combining treatments. Many clinicians will add a plano lens over the sound eye to atropine treatment, in part because families using atropine have become comfortable with its use. This option is limited to children with hypermetropia in the sound eye. However, it is unknown whether adding a plano lens over the sound eye will improve amblyopic eye visual acuity more than continuing atropine alone in patients who have shown no improvement after initial treatment with atropine. In a PEDIG randomized trial comparing patching to atropine for initial treatment of amblyopia, a plano lens was prescribed for the sound eye for 55 patients who had not improved to 20/30 or at least 3 lines after 4 months of daily atropine use.1, 4 Their mean acuity improvement prior to using the plano lens was 1.0 line, compared with 1.6 lines after prescribing the plano lens. We are unaware of any reports of the response of treatment of amblyopia still present after initial treatment with weekend atropine.
- Conditions
- Amblyopia
- Being tested
- Atropine, Plano lens
- Keywords
- Amblyopia, atropine, Plano lens
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Weekend atropine 1%
Plano lensDevice
plano lens over the sound eye
AtropineDrug
Weekend atropine 1%
| Study group | Role | What they receive |
|---|---|---|
| Intensified treatment | Active comparator | Weekend atropine 1% with plano lens over the sound eye Receives: Drug: Atropine; Device: Plano lens |
| Control | Active comparator | Weekend atropine 1% Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of 10-week Amblyopic-Eye Visual Acuity
The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Measured: 10 weeks after randomization
Mean 10-week Amblyopic-Eye Visual Acuity
The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Measured: 10 weeks after randomization
Distribution of the Change in Amblyopic-Eye Visual Acuity
The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Measured: Randomization to 10 weeks
Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization
The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.
The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Measured: Randomization to 10 weeks
Secondary outcomes (22)
Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization
The proportion of participants who achieved 20/25 or better visual acuity since randomization was computed at the 10-week outcome.
The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity was 20/25 or better since randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Measured: 10 weeks after randomization
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome.
The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Measured: 10 weeks after randomization
Spectacle Compliance at 10 Weeks by Treatment Group
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
Measured: 10 weeks after randomization
Average Spectacle Compliance by Treatment Group
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
Measured: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Atropine Compliance at 10 Weeks by Treatment Group
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
Measured: 10 weeks after randomization
Average Atropine Compliance by Treatment Group
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
Measured: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Distribution of Interocular Difference at 12-week Exam
Distribution of Interocular Difference Between Eyes at 12-week Exam
Measured: 12 weeks after randomization
Mean Interocular Difference at 12-week Exam
Mean Interocular Difference Between Eyes at 12-week Exam
Measured: 12 weeks after randomization
Distribution of 12-week Fellow-Eye Visual Acuity
Following the 10-week primary outcome exam, participants discontinued the randomized treatment and returned 2 weeks later for a 12-week visit to measure off-treatment fellow-eye visual acuity.
Measured: 12 weeks after randomization
Mean Fellow-Eye Visual Acuity at 12-week Exam
Measured: 12 weeks after randomization
Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
Measured: 12 weeks after randomization
Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
Measured: 12 weeks after randomization
Distribution of Baseline Characteristics at the 10-week Outcome
The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to principles specified in the primary outcome analysis.
Measured: 10 weeks after randomization
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Measured: 10 weeks after randomization
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
Measured: 10 weeks after randomization
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
Measured: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.
Measured: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
Measured: Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)
Measured: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Outcome Visit
Measured: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks; Participants with a Randot Preschool test of >800 seconds of arc were classified as having a stereoacuity of 3000 seconds of arc if the Titmus fly test was positive or as nil if the Titmus fly test was negative.
Measured: 12 weeks after randomization
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
Measured: 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- David K. Wallace, M.D., Study chair, Duke University Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944710
- Sponsor's protocol ID
- NEI-144
- Other IDs
- 2U10EY011751
- Acronym
- ATS16
- Status last verified
- Feb 2019
- First submitted
- 21 Jul 2009
- Last updated
- 6 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website at http://pedig.jaeb.org/Studies.aspx?RecID=30
Publications
Pediatric Eye Disease Investigator Group; Wallace DK, Lazar EL, Repka MX, Holmes JM, Kraker RT, Hoover DL, Weise KK, Waters AL, Rice ML, Peters RJ. A randomized trial of adding a plano lens to atropine for amblyopia. J AAPOS. 2015 Feb;19(1):42-8. doi: 10.1016/j.jaapos.2014.10.022.
PubMed 25727586
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
- ClinicalTrials.gov ID
- NCT00944710
- Acronym / sponsor ID
- ATS16 / NEI-144
- Conditions
- Amblyopia
- Keywords
- Amblyopia, atropine, Plano lens
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Aug 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Posted 24 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.
Detailed description
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children.1 Many practitioners prescribe weekend atropine as initial therapy for amblyopia. However, many children fail to achieve normal visual acuity in the amblyopic eye after treatment with this regimen. In a randomized trial conducted by PEDIG comparing atropine regimens, 58 of 83 patients with moderate amblyopia (70%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of treatment with weekend atropine.2 In another PEDIG randomized trial comparing atropine with a plano lens versus without a plano lens for initial treatment of amblyopia, 60 of 84 patients with moderate amblyopia (71%) had amblyopic eye visual acuity of 20/32 or worse after 16 weeks of treatment with weekend atropine.3 When improvement stops after initial therapy and amblyopia is still present, treatment options include increasing the dosage of current treatment, switching to another treatment, maintaining the same treatment and dosage, or combining treatments. Many clinicians will add a plano lens over the sound eye to atropine treatment, in part because families using atropine have become comfortable with its use. This option is limited to children with hypermetropia in the sound eye. However, it is unknown whether adding a plano lens over the sound eye will improve amblyopic eye visual acuity more than continuing atropine alone in patients who have shown no improvement after initial treatment with atropine. In a PEDIG randomized trial comparing patching to atropine for initial treatment of amblyopia, a plano lens was prescribed for the sound eye for 55 patients who had not improved to 20/30 or at least 3 lines after 4 months of daily atropine use.1, 4 Their mean acuity improvement prior to using the plano lens was 1.0 line, compared with 1.6 lines after prescribing the plano lens. We are unaware of any reports of the response of treatment of amblyopia still present after initial treatment with weekend atropine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified treatment | Active comparator | Drug: Atropine, Device: Plano lensWeekend atropine 1% with plano lens over the sound eye |
| Control | Active comparator | Drug: AtropineWeekend atropine 1% |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- Major Eligibility Criteria for Run-in Phase
- Age 3 to < 8 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
- Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines
Key exclusion criteria (5 listed)
- Currently using vision therapy or orthoptics
- Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
- Prior intraocular or refractive surgery
- Known allergy to atropine or other cycloplegic drugs
- Down Syndrome present
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtropineWeekend atropine 1% | Drug | Intensified treatment |
| Plano lensplano lens over the sound eye | Device | Intensified treatment |
| AtropineWeekend atropine 1% | Drug | Control |
Primary outcome
Distribution of 10-week Amblyopic-Eye Visual Acuity
Time frame: 10 weeks after randomization
The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Mean 10-week Amblyopic-Eye Visual Acuity
Time frame: 10 weeks after randomization
The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Distribution of the Change in Amblyopic-Eye Visual Acuity
Time frame: Randomization to 10 weeks
The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization
Time frame: Randomization to 10 weeks
The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis.
22 secondary outcomes
Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization
Time frame: 10 weeks after randomization
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
Time frame: 10 weeks after randomization
Spectacle Compliance at 10 Weeks by Treatment Group
Time frame: 10 weeks after randomization
Average Spectacle Compliance by Treatment Group
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Atropine Compliance at 10 Weeks by Treatment Group
Time frame: 10 weeks after randomization
Average Atropine Compliance by Treatment Group
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Distribution of Interocular Difference at 12-week Exam
Time frame: 12 weeks after randomization
Mean Interocular Difference at 12-week Exam
Time frame: 12 weeks after randomization
Distribution of 12-week Fellow-Eye Visual Acuity
Time frame: 12 weeks after randomization
Mean Fellow-Eye Visual Acuity at 12-week Exam
Time frame: 12 weeks after randomization
Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
Time frame: 12 weeks after randomization
Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
Time frame: 12 weeks after randomization
Distribution of Baseline Characteristics at the 10-week Outcome
Time frame: 10 weeks after randomization
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Time frame: 10 weeks after randomization
Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Time frame: 10 weeks after randomization
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
Time frame: Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Outcome Visit
Time frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
Time frame: 12 weeks after randomization
Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
Time frame: 12 weeks after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25727586Pediatric Eye Disease Investigator Group; Wallace DK, Lazar EL, Repka MX, Holmes JM, Kraker RT, Hoover DL, Weise KK, Waters AL, Rice ML, Peters RJ. A randomized trial of adding a plano lens to atropine for amblyopia. J AAPOS. 2015 Feb;19(1):42-8. doi: 10.1016/j.jaapos.2014.10.022.
- Individual participant dataSharing planned: Yes. In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website at http://pedig.jaeb.org/Studies.aspx?RecID=30
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David K. Wallace, M.D. study chair
Duke University Eye Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atropine and Plano lens in people with Amblyopia, run by Jaeb Center for Health Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of 10-week Amblyopic-Eye Visual Acuity (time frame: 10 weeks after randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00944710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.