AmblyopiaPhase 3ATS6NCT00315198
Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
A Phase 3 study testing Eye Patch, Near activities and Distance activities in people with Amblyopia, run by Jaeb Center for Health Research at 2 sites in United States.
Trial summary
Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to <7 years old. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Eye Patch, Near activities and Distance activities
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2005to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must be 3 to less than 7 years old with amblyopia due to strabismus, anisometropia, or both.
- Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR lines.
- Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.
Who cannot join
- Prior amblyopia treatment other than spectacles in the past month.
- More than one month of amblyopia treatment in the past 6 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University School of Optometry
Bloomington, Indiana, 47405
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to <7 years old.
Read the detailed description
The value of "near visual activities" while patching for amblyopia is controversial. Some pediatric eye care providers currently recommend that the child perform near visual tasks while wearing a patch over the sound eye, while other pediatric eye care providers do not prescribe any specific visual tasks to be performed while the patch is worn.
In previous randomized studies of patching doses for amblyopia conducted by the Pediatric Eye Disease Investigator Group, near visual activities were incorporated into the prescribed treatment regimes. Although different doses of patching, combined with near visual activities, were successful in improving visual acuity in most children, it is unclear whether concurrent near visual activities enhanced the effect of patching.
This study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments.
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 regimens for the 17 week treatment period are: 1) 2 hours of daily patching combined with near visual activities while patching and 2)2 hours of daily patching combined with distance visual activities while patching.
- Conditions
- Amblyopia
- Being tested
- Eye Patch, Near activities, Distance activities
- Keywords
- amblyopia, patching, visual activities
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye PatchDevice
Also called Coverlet, 3M Opticlude, Ortopad®
2 hours daily patching
Near activitiesProcedure or surgery
near visual activities while patching
Distance activitiesProcedure or surgery
distance visual activities while patching
| Study group | Role | What they receive |
|---|---|---|
| Near activities | Active comparator | 2 hours of daily patching combined with near visual activities while patching Receives: Device: Eye Patch; Procedure: Near activities |
| Distance activities | Active comparator | 2 hours of daily patching combined with distance visual activities while patching Receives: Device: Eye Patch; Procedure: Distance activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 8 weeks
Secondary outcomes (1)
Visual acuity
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startFeb 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Investigators
- Don Lyon, O.D., Study chair, Indiana UniversityJonathan M. Holmes, M.D., Study chair, Mayo Clinic Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315198
- Sponsor's protocol ID
- NEI-114
- Other IDs
- 2U10EY011751, 5U10EY011751
- Acronym
- ATS6
- Status last verified
- May 2009
- First submitted
- 14 Apr 2006
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pediatric Eye Disease Investigator Group. A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years. Ophthalmology. 2008 Nov;115(11):2071-8. doi: 10.1016/j.ophtha.2008.06.031. Epub 2008 Sep 11.
PubMed 18789533Wallace 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 22108357Repka 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
- ClinicalTrials.gov ID
- NCT00315198
- Acronym / sponsor ID
- ATS6 / NEI-114
- Conditions
- Amblyopia
- Keywords
- amblyopia, patching, visual activities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Feb 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to <7 years old.
Detailed description
The value of "near visual activities" while patching for amblyopia is controversial. Some pediatric eye care providers currently recommend that the child perform near visual tasks while wearing a patch over the sound eye, while other pediatric eye care providers do not prescribe any specific visual tasks to be performed while the patch is worn.
In previous randomized studies of patching doses for amblyopia conducted by the Pediatric Eye Disease Investigator Group, near visual activities were incorporated into the prescribed treatment regimes. Although different doses of patching, combined with near visual activities, were successful in improving visual acuity in most children, it is unclear whether concurrent near visual activities enhanced the effect of patching.
This study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments.
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 regimens for the 17 week treatment period are: 1) 2 hours of daily patching combined with near visual activities while patching and 2)2 hours of daily patching combined with distance visual activities while patching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near activities | Active comparator | Device: Eye Patch, Procedure: Near activities2 hours of daily patching combined with near visual activities while patching |
| Distance activities | Active comparator | Device: Eye Patch, Procedure: Distance activities2 hours of daily patching combined with distance visual activities while patching |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients must be 3 to less than 7 years old with amblyopia due to strabismus, anisometropia, or both.
- Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR lines.
- Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.
Key exclusion criteria (2 listed)
- Prior amblyopia treatment other than spectacles in the past month.
- More than one month of amblyopia treatment in the past 6 months.
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 |
|---|---|---|
| Eye PatchAlso: Coverlet, 3M Opticlude, Ortopad®2 hours daily patching | Device | Distance activities, Near activities |
| Near activitiesnear visual activities while patching | Procedure or surgery | Near activities |
| Distance activitiesdistance visual activities while patching | Procedure or surgery | Distance activities |
Primary outcome
Visual acuity
Time frame: 8 weeks
1 secondary outcome
Visual acuity
Time frame: 17 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
- Results publication: PubMed 18789533Pediatric Eye Disease Investigator Group. A randomized trial of near versus distance activities while patching for amblyopia in children aged 3 to less than 7 years. Ophthalmology. 2008 Nov;115(11):2071-8. doi: 10.1016/j.ophtha.2008.06.031. Epub 2008 Sep 11.
- 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.
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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.
Don Lyon, O.D. study chair
Indiana University
Jonathan M. Holmes, M.D. study chair
Mayo Clinic Department of Ophthalmology
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 Eye Patch, Near activities and Distance 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 3 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 Mar 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual acuity (time frame: 8 weeks). 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 NCT00315198, which also lists 3 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 Mar 2010.