AmblyopiaPhase 3ATS11NCT00506675
Combined Patching-Atropine for Residual Amblyopia
A Phase 3 study testing Patching and Atropine in people with Amblyopia, run by Jaeb Center for Health Research at 1 site in United States.
Trial summary
This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Patching and Atropine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2009
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3 to < 10 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity in the amblyopic eye between 20/32 and 20/63 inclusive
- Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >= 2 logMAR lines
- Current/previous treatment with patching and/or atropine subject to the following stipulations:
- No simultaneous treatment with patching and atropine in the past 6 months
Show all 16Show fewer
- No prior use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
- Maximum level of any previous treatment:
- Patching: up to 42 hours per week (averaging 6 hours daily)
- Atropine: up to once daily
- Current treatment with 42 hours per week patching or daily atropine
- No improvement in best-corrected amblyopic eye visual acuity between two consecutive visits at least 6 weeks apart using the same testing method and optimal spectacle correction (if needed), with no improvement defined as follows:
- No lines of improvement
- For patients tested using E-ETDRS, letter score that is no more than 4 letters improved
- Wearing spectacles with optimal correction (if applicable)
- Investigator ready to wean or stop treatment
Who cannot join
- Current vision therapy or orthoptics
- Ocular cause for reduced visual acuity
- Prior intraocular or refractive surgery
- Strabismus surgery planned within 10 weeks
- Known allergy to atropine or other cycloplegic drugs
- Known skin reactions to patch or bandage adhesives
- Down Syndrome present
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Eye Center
Durham, North Carolina, 27710
About this study
Official title: A Randomized Trial to Evaluate Combined Patching-Atropine for Residual Amblyopia
This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia.
The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.
The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.
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. Despite best efforts with conventional treatment, some patients fail to achieve normal visual acuity in the amblyopic eye. In a randomized trial conducted by PEDIG comparing atropine versus patching in 3 to 6 year olds with moderate amblyopia (ATS1), 261 of 402 patients (65%) had amblyopic eye visual acuity of 20/32 or worse after 6 months of treatment with patching or atropine. Beyond 6 months, treatment was at investigator discretion, and two years after randomization, 181 of 363 children (50%) still had amblyopic eye visual acuity of 20/32 or worse. In a randomized trial conducted by PEDIG comparing patching regimens, 129 of 181 patients with moderate amblyopia (71%) and 145 of 157 patients with severe amblyopia (92%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of occlusion therapy. Many patients receive treatment beyond 6 months but still fail to achieve normal visual acuity in the amblyopic eye. It is unknown whether an intensive "final push" of combined treatment with daily patching and atropine will improve visual acuity in these patients. Although some clinicians prescribe simultaneous patching and atropine for selected patients, there are no published reports of its effectiveness. Also, we are not aware of reports of response to treatment of residual amblyopia.
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. Patients will be randomized to one of two treatment regimens:
- Intensive treatment: 42 hours per week of patching combined with daily atropine (1%)
- Control group: Weaning of the current treatment (two hours of daily patching for patients currently using patching and once weekly atropine for patients currently using atropine) for 4 weeks, then no treatment other than spectacles (if needed).
- Conditions
- Amblyopia
- Being tested
- Patching, Atropine
- 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.
PatchingDevice
Also called Coverlet, 3M Opticlude, Ortopad®
42 hours per week of patching
AtropineDrug
daily atropine (1%)
PatchingDevice
Also called Coverlet, 3M Opticlude, Ortopad®
two hours of daily patching for 4 weeks, then no treatment
AtropineDrug
once weekly atropine for 4 weeks, then no treatment
| Study group | Role | What they receive |
|---|---|---|
| Intensive | Active comparator | 42 hours per week of patching combined with atropine (1%) once daily in the sound eye, with spectacle correction (if needed) Receives: Device: Patching; Drug: Atropine |
| Weaning | Active comparator | For patients currently patching, reduce patching to two hours daily for four weeks, then no treatment thereafter except spectacle correction (if needed). For patients currently using atropine, reduce atropine to once weekly for 4 weeks, then no treatment thereafter except spectacle correction (if needed) Receives: Device: Patching; Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Measured: 10 Weeks
Mean (SD) Distribution of Visual Acuity at 10 Weeks
Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Measured: 10 Weeks
Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks
Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.
Measured: baseline to 10 Weeks
Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam
Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.
Measured: baseline to 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionSep 2009
Why it stopped: Poor enrollment and infeasibility of ever reaching the necessary sample size
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
- 55 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
- Principal investigator, Ray Kraker, Jaeb Center for Health Research
- Investigators
- David K. Wallace, M.D., Study chair, Duke University Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506675
- Sponsor's protocol ID
- NEI-135
- Other IDs
- 2U10EY011751
- Acronym
- ATS11
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2007
- Last updated
- 13 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pediatric Eye Disease Investigator Group (PEDIG) Writing Committee; Wallace DK, Kraker RT, Beck RW, Cotter SA, Davis PL, Holmes JM, Repka MX, Suh DW. Randomized trial to evaluate combined patching and atropine for residual amblyopia. Arch Ophthalmol. 2011 Jul;129(7):960-2. doi: 10.1001/archophthalmol.2011.174. No abstract available.
PubMed 21746992
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate Combined Patching-Atropine for Residual Amblyopia
- ClinicalTrials.gov ID
- NCT00506675
- Acronym / sponsor ID
- ATS11 / NEI-135
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Atropine, Patching
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment and infeasibility of ever reaching the necessary sample size
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 23 Mar 2011
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 treatment of residual amblyopia in children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia.
The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.
The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.
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. Despite best efforts with conventional treatment, some patients fail to achieve normal visual acuity in the amblyopic eye. In a randomized trial conducted by PEDIG comparing atropine versus patching in 3 to 6 year olds with moderate amblyopia (ATS1), 261 of 402 patients (65%) had amblyopic eye visual acuity of 20/32 or worse after 6 months of treatment with patching or atropine. Beyond 6 months, treatment was at investigator discretion, and two years after randomization, 181 of 363 children (50%) still had amblyopic eye visual acuity of 20/32 or worse. In a randomized trial conducted by PEDIG comparing patching regimens, 129 of 181 patients with moderate amblyopia (71%) and 145 of 157 patients with severe amblyopia (92%) had amblyopic eye visual acuity of 20/32 or worse after 4 months of occlusion therapy. Many patients receive treatment beyond 6 months but still fail to achieve normal visual acuity in the amblyopic eye. It is unknown whether an intensive "final push" of combined treatment with daily patching and atropine will improve visual acuity in these patients. Although some clinicians prescribe simultaneous patching and atropine for selected patients, there are no published reports of its effectiveness. Also, we are not aware of reports of response to treatment of residual amblyopia.
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. Patients will be randomized to one of two treatment regimens:
- Intensive treatment: 42 hours per week of patching combined with daily atropine (1%)
- Control group: Weaning of the current treatment (two hours of daily patching for patients currently using patching and once weekly atropine for patients currently using atropine) for 4 weeks, then no treatment other than spectacles (if needed).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive | Active comparator | Device: Patching, Drug: Atropine42 hours per week of patching combined with atropine (1%) once daily in the sound eye, with spectacle correction (if needed) |
| Weaning | Active comparator | Device: Patching, Drug: AtropineFor patients currently patching, reduce patching to two hours daily for four weeks, then no treatment thereafter except spectacle correction (if needed). For patients currently using atropine, reduce atropine to once weekly for 4 weeks, then no treatment thereafter except spectacle correction (if needed) |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Age 3 to < 10 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity in the amblyopic eye between 20/32 and 20/63 inclusive
- Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >= 2 logMAR lines
- Current/previous treatment with patching and/or atropine subject to the following stipulations:
Key exclusion criteria (7 listed)
- Current vision therapy or orthoptics
- Ocular cause for reduced visual acuity
- Prior intraocular or refractive surgery
- Strabismus surgery planned within 10 weeks
- Known allergy to atropine or other cycloplegic drugs
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 |
|---|---|---|
| PatchingAlso: Coverlet, 3M Opticlude, Ortopad®42 hours per week of patching | Device | Intensive |
| Atropinedaily atropine (1%) | Drug | Intensive |
| PatchingAlso: Coverlet, 3M Opticlude, Ortopad®two hours of daily patching for 4 weeks, then no treatment | Device | Weaning |
| Atropineonce weekly atropine for 4 weeks, then no treatment | Drug | Weaning |
Primary outcome
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
Time frame: 10 Weeks
Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Mean (SD) Distribution of Visual Acuity at 10 Weeks
Time frame: 10 Weeks
Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to <7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to <10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks
Time frame: baseline to 10 Weeks
Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.
Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam
Time frame: baseline to 10 Weeks
Change in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21746992Pediatric Eye Disease Investigator Group (PEDIG) Writing Committee; Wallace DK, Kraker RT, Beck RW, Cotter SA, Davis PL, Holmes JM, Repka MX, Suh DW. Randomized trial to evaluate combined patching and atropine for residual amblyopia. Arch Ophthalmol. 2011 Jul;129(7):960-2. doi: 10.1001/archophthalmol.2011.174. No abstract available.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Patching and Atropine in people with Amblyopia, run by Jaeb Center for Health Research at 1 site 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 16 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 23 Mar 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 Amblyopic Eye Visual Acuity at 10 Weeks (time frame: 10 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 NCT00506675, 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 13 Jul 2016.