AmblyopiaPhase 3NCT00091923
Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children
A Phase 3 study testing Eye patch and Spectacles in people with Amblyopia, run by Jaeb Center for Health Research at 2 sites in United States.
Trial summary
The objectives of the Spectacle Phase are: In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine 1. the incidence of resolution of amblyopia with spectacle correction alone and 2. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Eye patch and Spectacles
- Type of treatment
- Medical device
- How many people
- 268 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2004to Dec 2005
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3 to <7 years
- Able to perform visual acuity using the ATS single-surround HOTV protocol
- Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
- Visual acuity in the amblyopic eye 20/40 to 20/400 inclusive
- Visual acuity in the sound eye >20/40
- Inter-eye acuity difference >3 logMAR lines
- Cycloplegic refraction and ocular examination within 2 months prior to enrollment
Who cannot join
- No amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
- No current vision therapy or orthoptics
- No ocular cause for reduced visual acuity
- No myopia more than a spherical equivalent of -6.00 D
- No prior intraocular or refractive surgery
- No known skin reactions to patch or bandage adhesives
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
Official title: A Randomized Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children 3 to <7 Years Old
The objectives of the Spectacle Phase are:
- In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine
Read more
- the incidence of resolution of amblyopia with spectacle correction alone and
- the time course of visual acuity improvement with spectacle correction alone.
- In all other patients, to achieve maximal improvement with spectacle correction prior to entering the randomized trial.
The objectives of the Randomized Trial are:
- To determine whether 5 weeks of patching treatment (2 hours of patching per day of the sound eye combined with at least one concurrent hour of near activities), compared with a control group (using spectacle correction only), improves visual acuity in patients with moderate to severe amblyopia (20/40 to 20/400).
- To determine the maximal improvement and time course of improvement with this patching treatment regimen.
Read the detailed description
There are few data on the improvement that occurs with spectacle correction alone in cases of anisometropic amblyopia. The only published study of which we are aware is that of Moseley, et al, who found that 8 of 12 patients prescribed spectacles for the first time improved 3 or more lines in the amblyopic eye. Therefore, the Spectacle Phase of the current study will provide important information related to the management of patients with anisometropic amblyopia.
Additionally, despite clinical experience that strongly indicates that amblyopia can be improved with treatment, there are those who claim that the benefit of treatment is unproven. Although improvement with amblyopia therapy has been shown in prospective trials, there have been no conclusive data published from a randomized trial evaluating the effect of amblyopia treatment compared with a control group. Therefore, we have designed a randomized trial to definitively address this issue.
In the trial, the effect on amblyopic eye acuity after five weeks of 2 hours of prescribed daily patching (combined with at least one hour of concurrent near activities) will be compared with a control group using spectacle correction only. In a study conducted by the Pediatric Eye Disease Investigator Group, a 2-hour daily patching treatment regimen improved moderate amblyopia (20/40 to 20/80) by an amount similar to the improvement seen with 6 hours of daily patching.
At the end of five weeks, patients whose amblyopic eye has improved from baseline will continue in follow up, using the assigned treatment, until the amblyopic eye acuity stops improving or until the amblyopia resolves. This will provide data on the maximum improvement achievable with this treatment regimen and on the time course to reach maximal improvement. There is no known harm in deferring treatment of amblyopia for five weeks in the age range to be included in the trial (3 to <7 years old). Standard care for a patient with amblyopia includes prescribing spectacle correction and having the patient return in 4 to 6 weeks for measurement of visual acuity. Spectacles alone are continued as long as the acuity in the amblyopic eye is improving. Once the acuity stops improving, occlusion or other active treatment is initiated. The maximum delay in active treatment of the control group beyond the standard of care is 5 weeks. In our prior Amblyopia Treatment Study protocols on patients in this age range, we have found no indication that the response to patching treatment is related to age. Therefore, it is highly unlikely that a delay in initiating treatment of weeks or even months could be harmful.
This study is addressing issues related to the treatment of amblyopia in children 3 to <7 years old with visual acuity 20/40 to 20/400. The study consists of two phases:
- a Spectacle Phase in which patients are prescribed spectacles and followed until maximal improvement in visual acuity has occurred and
- a Randomized Trial comparing a group using patching treatment (in addition to spectacle correction) with a control group using spectacle correction only.
The sample size for the primary analysis for the randomized trial has been estimated to be 134 patients. Patients will be enrolled into the Spectacle Phase until the recruitment goal for the Randomized Trial is reached.
- Conditions
- Amblyopia
- Being tested
- Eye patch, Spectacles
- 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
SpectaclesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal improvement in visual acuity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2004 (estimated)
- Study startFeb 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 268 participants
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Investigators
- David K. Wallace, M.D., Study chair, Duke University Eye CenterSusan A. Cotter, O.D., Study chair, Southern California College of Optometry at Marshall B. Ketchum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091923
- Sponsor's protocol ID
- NEI-96
- Other IDs
- 2U10EY011751, 5U10EY011751
- Status last verified
- Sep 2009
- First submitted
- 20 Sep 2004
- Last updated
- 24 Mar 2010
- Results posted
- No
Publications
Cotter SA; Pediatric Eye Disease Investigator Group; Edwards AR, Wallace DK, Beck RW, Arnold RW, Astle WF, Barnhardt CN, Birch EE, Donahue SP, Everett DF, Felius J, Holmes JM, Kraker RT, Melia M, Repka MX, Sala NA, Silbert DI, Weise KK. Treatment of anisometropic amblyopia in children with refractive correction. Ophthalmology. 2006 Jun;113(6):895-903. doi: 10.1016/j.ophtha.2006.01.068.
PubMed 16751032Wallace DK; Pediatric Eye Disease Investigator Group; Edwards AR, Cotter SA, Beck RW, Arnold RW, Astle WF, Barnhardt CN, Birch EE, Donahue SP, Everett DF, Felius J, Holmes JM, Kraker RT, Melia M, Repka MX, Sala NA, Silbert DI, Weise KK. A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children. Ophthalmology. 2006 Jun;113(6):904-12. doi: 10.1016/j.ophtha.2006.01.069.
PubMed 16751033Wallace 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 to Evaluate 2 Hours of Daily Patching for Amblyopia in Children 3 to <7 Years Old
- ClinicalTrials.gov ID
- NCT00091923
- Acronym / sponsor ID
- NEI-96
- Conditions
- Amblyopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Feb 2004
- Study completion
- Dec 2005 (actual)
- First posted
- 22 Sep 2004 (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.
The objectives of the Spectacle Phase are:
- In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine
- the incidence of resolution of amblyopia with spectacle correction alone and
- the time course of visual acuity improvement with spectacle correction alone.
- In all other patients, to achieve maximal improvement with spectacle correction prior to entering the randomized trial.
The objectives of the Randomized Trial are:
- To determine whether 5 weeks of patching treatment (2 hours of patching per day of the sound eye combined with at least one concurrent hour of near activities), compared with a control group (using spectacle correction only), improves visual acuity in patients with moderate to severe amblyopia (20/40 to 20/400).
- To determine the maximal improvement and time course of improvement with this patching treatment regimen.
Detailed description
There are few data on the improvement that occurs with spectacle correction alone in cases of anisometropic amblyopia. The only published study of which we are aware is that of Moseley, et al, who found that 8 of 12 patients prescribed spectacles for the first time improved 3 or more lines in the amblyopic eye. Therefore, the Spectacle Phase of the current study will provide important information related to the management of patients with anisometropic amblyopia.
Additionally, despite clinical experience that strongly indicates that amblyopia can be improved with treatment, there are those who claim that the benefit of treatment is unproven. Although improvement with amblyopia therapy has been shown in prospective trials, there have been no conclusive data published from a randomized trial evaluating the effect of amblyopia treatment compared with a control group. Therefore, we have designed a randomized trial to definitively address this issue.
In the trial, the effect on amblyopic eye acuity after five weeks of 2 hours of prescribed daily patching (combined with at least one hour of concurrent near activities) will be compared with a control group using spectacle correction only. In a study conducted by the Pediatric Eye Disease Investigator Group, a 2-hour daily patching treatment regimen improved moderate amblyopia (20/40 to 20/80) by an amount similar to the improvement seen with 6 hours of daily patching.
At the end of five weeks, patients whose amblyopic eye has improved from baseline will continue in follow up, using the assigned treatment, until the amblyopic eye acuity stops improving or until the amblyopia resolves. This will provide data on the maximum improvement achievable with this treatment regimen and on the time course to reach maximal improvement. There is no known harm in deferring treatment of amblyopia for five weeks in the age range to be included in the trial (3 to <7 years old). Standard care for a patient with amblyopia includes prescribing spectacle correction and having the patient return in 4 to 6 weeks for measurement of visual acuity. Spectacles alone are continued as long as the acuity in the amblyopic eye is improving. Once the acuity stops improving, occlusion or other active treatment is initiated. The maximum delay in active treatment of the control group beyond the standard of care is 5 weeks. In our prior Amblyopia Treatment Study protocols on patients in this age range, we have found no indication that the response to patching treatment is related to age. Therefore, it is highly unlikely that a delay in initiating treatment of weeks or even months could be harmful.
This study is addressing issues related to the treatment of amblyopia in children 3 to <7 years old with visual acuity 20/40 to 20/400. The study consists of two phases:
- a Spectacle Phase in which patients are prescribed spectacles and followed until maximal improvement in visual acuity has occurred and
- a Randomized Trial comparing a group using patching treatment (in addition to spectacle correction) with a control group using spectacle correction only.
The sample size for the primary analysis for the randomized trial has been estimated to be 134 patients. Patients will be enrolled into the Spectacle Phase until the recruitment goal for the Randomized Trial is reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 3 to <7 years
- Able to perform visual acuity using the ATS single-surround HOTV protocol
- Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
- Visual acuity in the amblyopic eye 20/40 to 20/400 inclusive
- Visual acuity in the sound eye >20/40
Key exclusion criteria (6 listed)
- No amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
- No current vision therapy or orthoptics
- No ocular cause for reduced visual acuity
- No myopia more than a spherical equivalent of -6.00 D
- No prior intraocular or refractive surgery
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 patch | Device | – |
| Spectacles | Device | – |
Primary outcome
maximal improvement in visual acuity
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 16751032Cotter SA; Pediatric Eye Disease Investigator Group; Edwards AR, Wallace DK, Beck RW, Arnold RW, Astle WF, Barnhardt CN, Birch EE, Donahue SP, Everett DF, Felius J, Holmes JM, Kraker RT, Melia M, Repka MX, Sala NA, Silbert DI, Weise KK. Treatment of anisometropic amblyopia in children with refractive correction. Ophthalmology. 2006 Jun;113(6):895-903. doi: 10.1016/j.ophtha.2006.01.068.
- Results publication: PubMed 16751033Wallace DK; Pediatric Eye Disease Investigator Group; Edwards AR, Cotter SA, Beck RW, Arnold RW, Astle WF, Barnhardt CN, Birch EE, Donahue SP, Everett DF, Felius J, Holmes JM, Kraker RT, Melia M, Repka MX, Sala NA, Silbert DI, Weise KK. A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children. Ophthalmology. 2006 Jun;113(6):904-12. doi: 10.1016/j.ophtha.2006.01.069.
- 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.
- Pediatric Eye Disease Investigator GroupLink 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.
David K. Wallace, M.D. study chair
Duke University Eye Center
Susan A. Cotter, O.D. study chair
Southern California College of Optometry at Marshall B. Ketchum University
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 and Spectacles 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 7 inclusion and 6 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?
maximal improvement in visual acuity. 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 NCT00091923, which also lists 4 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.