Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094692
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
2004-10-21
Brief Title:
An Evaluation of Treatment of Amblyopia in Children 7 To 18 Years Old
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
An Evaluation of Treatment of Amblyopia in 7 To 18 Year Olds
Status:
COMPLETED
Status Verified Date:
2007-05
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 goals of this study are
To determine the response rate of treatment of amblyopia in 7 to 18 year olds
To determine the frequency of recurrence of amblyopia in 7 to 18 year olds after discontinuation of amblyopia treatment
To determine the response rate of treatment of amblyopia in 7 to 18 year olds
To determine the frequency of recurrence of amblyopia in 7 to 18 year olds after discontinuation of amblyopia treatment
Detailed Description:
Most eye care practitioners believe that there is an age beyond which attempting to treat amblyopia is futile It is generally held that the response to treatment is best when it is instituted at an early age and is poor when attempted after eight years of age There has not been a prospective clinical trial conducted with appropriate rigor that has evaluated the effect of treatment of amblyopia in children aged 7 years or older Although available data on the efficacy of amblyopia treatment of older children are limited there is reason to believe from clinical observations and published case series that treatment could have benefit In a pilot study of patients 10 to 18 years old with amblyopia we found that 37 percent of 52 patients showed improvement in the amblyopic eye acuity of 2 or more lines after treatment with part-time patching However without a concurrent randomized control group the results are not conclusive Although the literature and our pilot study provide support that amblyopia can be improved with treatment neither the response rate to treatment nor the recidivism rate after cessation of treatment can be well defined Despite the evidence that amblyopia therapy can be effective in older children many clinicians do not attempt treatment under the assumption that it will be unsuccessful Therefore a clinical trial is needed to provide the requisite data to establish clinical practice guidelines for the treatment of amblyopia in older children In addition to its importance for patient management the trials results will meet the demand for cost effectiveness by health maintenance organizations large employers and insurers
The study is a randomized trial comparing patients treated with spectacles only Control Group to patients undergoing active treatment patching near activities while patching and atropine for children under the age of 13 in addition to spectacles Active Treatment Group It will enroll a minimum of 90 patients in each of the age groups of 7 to 9 9 to 11 11 to 13 and 13 to 18 years old Patients have follow up visits every 6 weeks up to a maximum of 24 weeks until they are classified as either responders or nonresponders based on amblyopic eye visual acuity At the end of the randomized trial
Patients who did not respond to treatment end follow up
Patients who responded to treatment continue in their respective treatment groups until visual acuity stops improving
Once there is no further improvement in visual acuity
Patients in the Control Group end follow up
Patients in the Active Treatment Group discontinue active treatment and have follow up visits at 13 weeks 26 weeks and 52 weeks timed from treatment discontinuation
The study is a randomized trial comparing patients treated with spectacles only Control Group to patients undergoing active treatment patching near activities while patching and atropine for children under the age of 13 in addition to spectacles Active Treatment Group It will enroll a minimum of 90 patients in each of the age groups of 7 to 9 9 to 11 11 to 13 and 13 to 18 years old Patients have follow up visits every 6 weeks up to a maximum of 24 weeks until they are classified as either responders or nonresponders based on amblyopic eye visual acuity At the end of the randomized trial
Patients who did not respond to treatment end follow up
Patients who responded to treatment continue in their respective treatment groups until visual acuity stops improving
Once there is no further improvement in visual acuity
Patients in the Control Group end follow up
Patients in the Active Treatment Group discontinue active treatment and have follow up visits at 13 weeks 26 weeks and 52 weeks timed from treatment discontinuation
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 | httpsreporternihgovquickSearch2U10EY011751 |