Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091923
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
2004-09-20
Brief Title:
Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
A Randomized Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children 3 to 7 Years Old
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of the Spectacle Phase are
In previously untreated pure anisometropic patients ie 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 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 2040 to 20400
To determine the maximal improvement and time course of improvement with this patching treatment regimen
In previously untreated pure anisometropic patients ie 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 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 2040 to 20400
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 2040 to 2080 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 2040 to 20400 The study consists of two phases
1 a Spectacle Phase in which patients are prescribed spectacles and followed until maximal improvement in visual acuity has occurred and
2 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
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 2040 to 2080 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 2040 to 20400 The study consists of two phases
1 a Spectacle Phase in which patients are prescribed spectacles and followed until maximal improvement in visual acuity has occurred and
2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2U10EY011751 | NIH | None | None |
| 5U10EY011751 | NIH | None | httpsreporternihgovquickSearch5U10EY011751 |