AmblyopiaPhase 3ATS9NCT00315328

Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

A Phase 3 study testing Atropine, Patching and Near activities in people with Amblyopia, run by Jaeb Center for Health Research at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is: To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds. Read more about this study

Who is it for?: Ages 7 to 12 years
Conditions the study is for: Amblyopia
What is being tested?: Atropine, Patching and Near activities
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 233 participants
Where: 2 sitesUnited States
Study dates: Aug 2005to Jan 2008
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 7 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age 7 to 12 years old (inclusive)
Amblyopia associated with strabismus, anisometropia, or both
Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)
Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better)
Interocular difference >=15 letters (3 lines)
Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable

Show all 10Show fewer

Enrolled into the main study
Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error)
Birth weight >1500 grams
No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy

Who cannot join

Amblyopia treatment (other than spectacles) in the last 6 months
Myopia (more than -0.25D spherical equivalent) in either eye

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Randomized Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds

The purpose of this study is:

To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.
To determine the maximum improvement in vision of the amblyopic eye with each treatment.
To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

Read the detailed description

Although there is consensus that amblyopia can be treated effectively in young children, many eye care practitioners believe that treatment beyond a certain age is ineffective. Some clinicians have believed that a treatment response is unlikely after the age of 6 or 7 years, while others have considered age 9 or 10 years to be the upper age limit for successful treatment. The American Academy of Ophthalmology Preferred Practice Pattern for amblyopia recommends treatment up to age 10 years. The opinion that amblyopia treatment is ineffective in older children may have arisen because the age of 6 to 7 years is thought to be the end of the "critical period" for visual development in humans. This belief, however, was not based on adequate prospectively-collected data.

To address this issue of the response of amblyopia to treatment in children 7 years and older, the Pediatric Eye Disease Investigator Group (PEDIG) conducted a randomized trial of 507 patients (aged 7 to <18 years) with amblyopic eye visual acuity ranging from 20/40 to 20/400. Patients were provided with optimal optical correction and then randomized to a Treatment Group (2 to 6 hours per day of prescribed patching of the sound eye combined with near visual activities for all patients plus atropine one drop per day in the sound eye for 7 to <13 year olds) or an Optical Correction Group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (2 lines) by 24 weeks were considered responders. In the 7 to <13 year olds (N=404), 53% of the Treatment Group were responders compared with 25% of the Optical Correction Group (P<0.001). In the 13 to <18 year olds (N=103), the responder rates were 25% and 23% respectively overall (adjusted P=0.22), but 47% and 20% respectively among patients not previously treated with patching and/or atropine for amblyopia (adjusted P=0.03). Most patients, including responders, were left with a residual visual acuity deficit.

The use of multiple modalities (patching, atropine, near visual activities) in the treatment regimen for the 7 to <13 year olds in this trial (ATS3) was an effort to maximize the therapeutic response. Patients age 13 years and older were prescribed patching but not atropine because of concern that the continual optical blur from the atropine could have a deleterious effect on their ability to drive and perform other activities. Prescribed patching was 2 to 6 hours a day to limit patch wear to non-school hours and because our prior studies of 3 to <7 year olds demonstrated that as little as two hours of patching a day (when combined with near visual activities) is as effective as a greater number of hours. Instructing patients to perform at least one hour of near activities while wearing the patch was based on the unproven clinical opinion that near activities can augment the effect of the occlusion therapy. A PEDIG pilot study suggested that near activities are beneficial and this question of benefit of near activities is currently being studied in another randomized clinical trial. Atropine placed in the sound eye once a day and two days a week has been demonstrated in younger children to be beneficial to the acuity of the amblyopic eye, presumably due to its cycloplegic effect of blurring vision in the sound eye especially at near fixation. In a study comparing daily and weekend atropine, daily atropine was not found to be superior.

The unanswered question from this completed clinical trial is whether prescribing patching or atropine alone could have produced a response similar to the combination therapy, or whether in this age group, one treatment is better than the other. A poll of PEDIG investigators at an investigator meeting on January 15, 2005 indicated that very few are following the treatment regimen used in the prior study (ATS3); rather, most are prescribing monotherapy-either patching or atropine-as the initial treatment for amblyopia in the 7 to <13 year age range. Thus, a trial comparing atropine and patching as amblyopia treatments in 7 to <13 year olds is needed.

The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes are: 1) Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day without the aid of reading glasses (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters) and 2) Patching 2 hours per day plus near activities for one hour while patching (with increase to 4 hours per day for moderate amblyopes and > 4 hours per day for severe amblyopes at 5 weeks if acuity not improved by at least 5 letters).

Optional Ancillary Study As part of the optic nerve imaging ancillary study, retinal nerve fiber layer imaging using optical coherence tomography will be performed on some patients. This will be optional for patients at participating sites. The procedure is not part of standard care. The subject's pupils will need to be dilated, if not already dilated as part of the exam. Testing of both eyes can be completed in about 15 minutes.

Conditions: Amblyopia
Being tested: Atropine, Patching, Near activities
Keywords: Amblyopia, Atropine, Patching
Medical subject headings: Amblyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtropineDrug
Atropine 1% each weekend day in the sound eye
PatchingDevice
Also called Coverlet, 3M Opticlude, Ortopad®
Patching 2 hours per day
Near activitiesProcedure or surgery
near visual activities for at least one hour per day

Study groups in NCT00315328
Study group	Role	What they receive
Patching	Active comparator	Patching 2 hours per day plus near activities for one hour while patching (with increase to 4 hours per day for moderate amblyopes and >4 hours per day for severe amblyopes at 5 weeks if acuity not improved at least 5 letters) Receives: Device: Patching; Procedure: Near activities
Atropine	Active comparator	Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters) Receives: Drug: Atropine; Procedure: Near activities

What is being measured

The primary outcome is the main question the study is designed to answer.

Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Measured: 17 weeks
Mean Visual Acuity in the Amblyopic Eye at 17 Weeks
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Measured: 17 weeks
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.
A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Measured: Baseline to 17 weeks
Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.
A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Measured: Baseline to 17 weeks

Secondary outcomes (11)

Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Measured: 17 or 19 weeks
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Measured: 17 or 19 weeks
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score >800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.
Measured: 17 or 19 weeks
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
Stereoacuity is scored as seconds of arc with values of: <800, 800, 400, 200, 100, 60, 40. The lower the arc second value, the better the score (i.e. 40 arc sec is best stereoacuity; <800 is the worst). A change score was defined as the difference between baseline and outcome in score level (i.e. moving from 800 at baseline to 400 at outcome is one level change, moving from 800 to 200 is two levels, etc.) change in levels was categorized as "within one level" meaning change was -1, 0, or +1.
Measured: 17 or 19 weeks
Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)
Questionnaire scores on the Social Stigma subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Measured: 17 weeks
Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)
Questionnaire scores on the compliance subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Measured: 17 weeks
Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)
Questionnaire scores on the adverse events subscale of the Amblyopia Treatment Index. Questions were evaluated on a likert type scale as strongly agree (5) to strongly disagree (1), with a higher number indicating worse response.
Measured: 17 weeks
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Measured: 17 weeks
Mean Visual Acuity in the Fellow Eye at 17 Weeks
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Measured: 17 weeks
Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.
A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Measured: Baseline to 17 weeks
Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated.
A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Measured: Baseline to 17 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2005Jan 2008

First posted18 Apr 2006 (estimated)
Study startAug 2005
Primary completionDec 2007
Study completionJan 2008

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 (7)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: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00315328
Sponsor's protocol ID: NEI-119
Other IDs: 2U10EY011751
Acronym: ATS9
Status last verified: May 2016
First submitted: 14 Apr 2006
Last updated: 24 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Repka MX, Kraker RT, Beck RW, Birch E, Cotter SA, Holmes JM, Hertle RW, Hoover DL, Klimek DL, Marsh-Tootle W, Scheiman MM, Suh DW, Weakley DR; Pediatric Eye Disease Investigator Group. Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials. J AAPOS. 2009 Jun;13(3):258-63. doi: 10.1016/j.jaapos.2009.03.002.
PubMed 19541265
Repka MX, Kraker RT, Tamkins SM, Suh DW, Sala NA, Beck RW; Pediatric Eye Disease Investigator Group. Retinal nerve fiber layer thickness in amblyopic eyes. Am J Ophthalmol. 2009 Jul;148(1):143-7. doi: 10.1016/j.ajo.2009.01.015. Epub 2009 Mar 27.
PubMed 19327749
Pediatric Eye Disease Investigator Group. Pharmacological plus optical penalization treatment for amblyopia: results of a randomized trial. Arch Ophthalmol. 2009 Jan;127(1):22-30. doi: 10.1001/archophthalmol.2008.520.
PubMed 19139333
Felius J, Chandler DL, Holmes JM, Chu RH, Cole SR, Hill M, Huang K, Kulp MT, Lazar EL, Matta NS, Melia M, Wallace DK; Pediatric Eye Disease Investigator Group. Evaluating the burden of amblyopia treatment from the parent and child's perspective. J AAPOS. 2010 Oct;14(5):389-95. doi: 10.1016/j.jaapos.2010.07.009.
PubMed 21035063
Scheiman MM, Hertle RW, Kraker RT, Beck RW, Birch EE, Felius J, Holmes JM, Kundart J, Morrison DG, Repka MX, Tamkins SM; Pediatric Eye Disease Investigator Group. Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial. Arch Ophthalmol. 2008 Dec;126(12):1634-42. doi: 10.1001/archophthalmol.2008.107.
PubMed 19064841
Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007.
PubMed 22108357
Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8.
PubMed 20451898

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Non-invasive Induction of Metaplasticity for Amblyopia
Amblyopia, Amblyopia Unilateral
Recruiting
Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children
Amblyopia
Recruiting
Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia
Amblyopia, Anisometropic Amblyopia
Recruiting
Combining Noninvasive Brain Stimulation and Augmented Reality-based Dichoptic Therapy for Treating Amblyopic Adults
Amblyopia, Anisometropic Amblyopia

All Amblyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds
ClinicalTrials.gov ID: NCT00315328
Acronym / sponsor ID: ATS9 / NEI-119
Conditions: Amblyopia
Keywords: Amblyopia, Atropine, Patching
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 233 participants (actual)
Lead sponsor: Jaeb Center for Health ResearchUniversity, hospital or other
Collaborators: National Eye Institute (NEI)
Study start: Aug 2005
Primary completion: Dec 2007 (actual)
Study completion: Jan 2008 (actual)
First posted: 18 Apr 2006 (estimated)
Results: Posted 6 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is:

To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.
To determine the maximum improvement in vision of the amblyopic eye with each treatment.
To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Patching	Active comparator	Device: Patching, Procedure: Near activitiesPatching 2 hours per day plus near activities for one hour while patching (with increase to 4 hours per day for moderate amblyopes and >4 hours per day for severe amblyopes at 5 weeks if acuity not improved at least 5 letters)
Atropine	Active comparator	Drug: Atropine, Procedure: Near activitiesAtropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters)

Who may qualify

Ages: 7 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Age 7 to 12 years old (inclusive)
Amblyopia associated with strabismus, anisometropia, or both
Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)
Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better)
Interocular difference >=15 letters (3 lines)

Key exclusion criteria (2 listed)

Amblyopia treatment (other than spectacles) in the last 6 months
Myopia (more than -0.25D spherical equivalent) in either eye

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
AtropineAtropine 1% each weekend day in the sound eye	Drug	Atropine
PatchingAlso: Coverlet, 3M Opticlude, Ortopad®Patching 2 hours per day	Device	Patching
Near activitiesnear visual activities for at least one hour per day	Procedure or surgery	Atropine, Patching

Primary outcome

Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks
Time frame: 17 weeks
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Mean Visual Acuity in the Amblyopic Eye at 17 Weeks
Time frame: 17 weeks
Visual acuity was measured in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.
Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
Time frame: Baseline to 17 weeks
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.
Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks
Time frame: Baseline to 17 weeks
Visual acuity was measured at baseline and 17 weeks in each eye using the electronic early treatment diabetic retinopathy study (E-ETDRS) method which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. A difference between the scores at baseline and 17 weeks was calculated. A positive difference indicates acuity was better at 17 weeks than at baseline; a negative difference indicates acuity was worse at 17 weeks.

11 secondary outcomes

Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
Time frame: 17 or 19 weeks
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Anisometropic Participants With Moderate Amblyopia Only
Time frame: 17 or 19 weeks
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With Moderate Amblyopia From Strabismus Only or Combined Mechanism
Time frame: 17 or 19 weeks
Stereoacuity Measured by the Randot Preschool Test at 17 or 19 Weeks- Participants With All Causes of Moderate Amblyopia
Time frame: 17 or 19 weeks
Amblyopia Treatment Index - Social Stigma (Moderate Amblyopia Only)
Time frame: 17 weeks
Amblyopia Treatment Index - Compliance (Moderate Amblyopia Only)
Time frame: 17 weeks
Amblyopia Treatment Index - Adverse Effects Scale (Moderate Amblyopia Only)
Time frame: 17 weeks
Distribution of Visual Acuity in the Fellow Eye at 17 Weeks
Time frame: 17 weeks
Mean Visual Acuity in the Fellow Eye at 17 Weeks
Time frame: 17 weeks
Distribution of Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
Time frame: Baseline to 17 weeks
Mean Change in Visual Acuity in the Fellow Eye From Baseline to 17 Weeks
Time frame: Baseline to 17 weeks

Results and safety

Results posted to the registry on 6 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patching-Moderate Amblyopia	98	84
Atropine-Moderate Amblyopia	95	88
Patching-Severe Amblyopia	18	13
Atropine-Severe Amblyopia	22	20

Primary outcome: Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks

Time frame: 17 weeks. Number. Unit: participants

Measure	Patching-Moderate Amblyopia n = 84	Atropine-Moderate Amblyopia n = 88	Patching-Severe Amblyopia n = 13	Atropine-Severe Amblyopia n = 20
20/400 (18 to 22 letters) (worse)	0	0	0	0
20/320 (23 to 27 letters)	0	0	0	1
20/250 (28 to 32 letters)	0	0	0	3
20/200 (33 to 37 letters)	0	0	3	3
20/160 (38 to 42 letters)	1	0	1	3
20/125 (43 to 47 letters)	0	1	4	2
20/100 (48 to 52 letters)	3	4	1	2
20/80 (53 to 57 letters)	3	6	4	3

Patching-Moderate Amblyopia vs Atropine-Moderate Amblyopia: Mean Difference (Net): 0.07 (95% CI -0.03 to 0.17)

Population analysed: Primary analysis includes only patients who completed the 17 week exam between 13 and 26 weeks following randomization. No imputation was done if missed exam; analysis followed the intent to treat principle.

Primary outcome: Mean Visual Acuity in the Amblyopic Eye at 17 Weeks

Time frame: 17 weeks. Mean (Standard Deviation). Unit: ETDRS letter score

Measure	Patching-Moderate Amblyopia n = 84	Atropine-Moderate Amblyopia n = 88	Patching-Severe Amblyopia n = 13	Atropine-Severe Amblyopia n = 20
Value	71.0 (8.9)	69.2 (9.2)	46.0 (6.0)	45.0 (14.0)

Primary outcome: Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks

Time frame: Baseline to 17 weeks. Number. Unit: participants

Measure	Patching-Moderate Amblyopia n = 84	Atropine-Moderate Amblyopia n = 88	Patching-Severe Amblyopia n = 13	Atropine-Severe Amblyopia n = 20
>=15 letters worse	1	0	0	0
10 to 14 letters worse	0	2	0	0
5 to 9 letters worse	0	3	0	2
+/- 4 letters	23	22	2	6
5 to 9 letters better	22	26	4	4
10 to 14 letters better	17	20	2	3
>=15 letters better	21	15	5	5

Patching-Moderate Amblyopia vs Atropine-Moderate Amblyopia: Mean Difference (Net): 0.08 (95% CI -0.02 to 0.18)

Primary outcome: Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks

Time frame: Baseline to 17 weeks. Mean (Standard Deviation). Unit: ETDRS letter score

Measure	Patching-Moderate Amblyopia n = 84	Atropine-Moderate Amblyopia n = 88	Patching-Severe Amblyopia n = 13	Atropine-Severe Amblyopia n = 20
Value	8.6 (7.8)	7.6 (7.5)	9.0 (6.5)	7.5 (10.5)

Patching-Moderate Amblyopia vs Atropine-Moderate Amblyopia: Mean Difference (Net): 1.2 (95% CI -0.7 to 3.1), ANCOVA

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through the 17 week outcome visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patching-Moderate Amblyopia	0 of 98 (0%)	0 of 98 (0%)	Not reported
Atropine-Moderate Amblyopia	0 of 95 (0%)	14 of 95 (14.7%)	Not reported
Patching-Severe Amblyopia	0 of 18 (0%)	0 of 18 (0%)	Not reported
Atropine-Severe Amblyopia	0 of 22 (0%)	5 of 22 (22.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19541265Repka MX, Kraker RT, Beck RW, Birch E, Cotter SA, Holmes JM, Hertle RW, Hoover DL, Klimek DL, Marsh-Tootle W, Scheiman MM, Suh DW, Weakley DR; Pediatric Eye Disease Investigator Group. Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials. J AAPOS. 2009 Jun;13(3):258-63. doi: 10.1016/j.jaapos.2009.03.002.
Background: PubMed 19327749Repka MX, Kraker RT, Tamkins SM, Suh DW, Sala NA, Beck RW; Pediatric Eye Disease Investigator Group. Retinal nerve fiber layer thickness in amblyopic eyes. Am J Ophthalmol. 2009 Jul;148(1):143-7. doi: 10.1016/j.ajo.2009.01.015. Epub 2009 Mar 27.
Background: PubMed 19139333Pediatric Eye Disease Investigator Group. Pharmacological plus optical penalization treatment for amblyopia: results of a randomized trial. Arch Ophthalmol. 2009 Jan;127(1):22-30. doi: 10.1001/archophthalmol.2008.520.
Background: PubMed 21035063Felius J, Chandler DL, Holmes JM, Chu RH, Cole SR, Hill M, Huang K, Kulp MT, Lazar EL, Matta NS, Melia M, Wallace DK; Pediatric Eye Disease Investigator Group. Evaluating the burden of amblyopia treatment from the parent and child's perspective. J AAPOS. 2010 Oct;14(5):389-95. doi: 10.1016/j.jaapos.2010.07.009.
Results publication: PubMed 19064841Scheiman MM, Hertle RW, Kraker RT, Beck RW, Birch EE, Felius J, Holmes JM, Kundart J, Morrison DG, Repka MX, Tamkins SM; Pediatric Eye Disease Investigator Group. Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial. Arch Ophthalmol. 2008 Dec;126(12):1634-42. doi: 10.1001/archophthalmol.2008.107.
Derived from this study: PubMed 22108357Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007.
Derived from this study: PubMed 20451898Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8.
PubMed AbstractLink provided by the sponsor.
PubMed Central HHS Public Access - Full TextLink provided by the sponsor.

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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.

Richard W. Hertle, M.D. study chair

University of Pittsburgh

Mitchell M. Scheiman, O.D. study chair

Pennsylvania College of Optometry

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, Patching and Near activities 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 10 inclusion and 2 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 24 Jun 2016. 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 6 Jun 2011). 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 Visual Acuity in the Amblyopic Eye at 17 Weeks (time frame: 17 weeks). 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 NCT00315328, which also lists 7 linked publications.

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 24 Jun 2016.