Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000170
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
1999-09-23
Brief Title:
Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
Amblyopia Treatment Study Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia
Status:
COMPLETED
Status Verified Date:
2014-03
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:
To determine whether the success rate with drug treatment atropine of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion patching therapy
To develop more precise estimates of the success rates of amblyopia treatment
To identify factors that may be associated with successful treatment of amblyopia
To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available
Extended Follow up of Study Patients
Primary To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years
Secondary To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
To develop more precise estimates of the success rates of amblyopia treatment
To identify factors that may be associated with successful treatment of amblyopia
To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available
Extended Follow up of Study Patients
Primary To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years
Secondary To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
Detailed Description:
Amblyopia or lazy eye is the most common cause of visual impairment in children and often persists in adulthood It is reported to be the leading cause of vision loss in one eye in the 20-70 year old age group with a prevalence of 1-4 percent in various studies indicating that both improved means of detection and treatment are needed
Most of the available data on the natural history of amblyopia and success rates of its treatment with either patching or drug therapy are retrospective and uncontrolled Despite the common occurrence of amblyopia there is little quality data on treatment of this condition Thus there is much to be learned about the course of treated amblyopia to provide more precise estimates of success rates and to identify factors that may be associated with successful and unsuccessful treatment
Amblyopia when diagnosed in children is usually treated with occlusion patching of the sound eye Occlusion therapy is subject to problems of compliance due to the childs dislike of wearing a patch for visual skin irritation and socialpsychological reasons There is evidence that compliance may be one of if not the most important determinant of success of amblyopia therapy
An alternative treatment drug therapy with a cycloplegic drug atropine that dilates the pupils and blurs the image seen by the sound eye has been known for almost a century This method has been widely used for the management of occlusion treatment failures and for maintenance therapy However it has seen little use as a primary treatment for amblyopia Clinical experience has found that it has a high acceptability to patients and parents and hence high compliance In addition to its acceptability pharmacologic therapy has the known advantage over occlusion of providing a wider visual field with both eyes which may have safety and other functional implications There is also clinical and laboratory evidence suggesting that drug therapy may maintain and improve the ability to see with both eyes binocularity
Available data suggest that the success rate with drug therapy is as good as if not better than the success rate with occlusion therapy for mild to moderate degrees of amblyopia If this is true for many children with amblyopia drug therapy may be the preferred initial therapy since it appears to be more readily accepted by the children and parents Despite data to support the use of drug therapy as a primary therapy for amblyopia it has gained only limited use among pediatric ophthalmologists A definitive study comparing the outcomes from occlusion therapy and drug therapy is justified in order to determine if new practice guidelines for treatment of amblyopia are needed
Regardless of whether the trial determines that one therapeutic approach is better than the other the data that are collected will provide valuable information about the course of amblyopia treatment that is not presently available The study also is expected to provide data that will help to determine whether factors such as age refractive status cause of amblyopia or fixation pattern should be considered in determining which procedure is best for a given patient
Extended Follow-up of Study Patients
The extended follow up study consists of annual visits prior to age 10 followed by a visit at age 10 years and a visit at age 15 years There is no amblyopia treatment that is required during the extended follow up period
Most of the available data on the natural history of amblyopia and success rates of its treatment with either patching or drug therapy are retrospective and uncontrolled Despite the common occurrence of amblyopia there is little quality data on treatment of this condition Thus there is much to be learned about the course of treated amblyopia to provide more precise estimates of success rates and to identify factors that may be associated with successful and unsuccessful treatment
Amblyopia when diagnosed in children is usually treated with occlusion patching of the sound eye Occlusion therapy is subject to problems of compliance due to the childs dislike of wearing a patch for visual skin irritation and socialpsychological reasons There is evidence that compliance may be one of if not the most important determinant of success of amblyopia therapy
An alternative treatment drug therapy with a cycloplegic drug atropine that dilates the pupils and blurs the image seen by the sound eye has been known for almost a century This method has been widely used for the management of occlusion treatment failures and for maintenance therapy However it has seen little use as a primary treatment for amblyopia Clinical experience has found that it has a high acceptability to patients and parents and hence high compliance In addition to its acceptability pharmacologic therapy has the known advantage over occlusion of providing a wider visual field with both eyes which may have safety and other functional implications There is also clinical and laboratory evidence suggesting that drug therapy may maintain and improve the ability to see with both eyes binocularity
Available data suggest that the success rate with drug therapy is as good as if not better than the success rate with occlusion therapy for mild to moderate degrees of amblyopia If this is true for many children with amblyopia drug therapy may be the preferred initial therapy since it appears to be more readily accepted by the children and parents Despite data to support the use of drug therapy as a primary therapy for amblyopia it has gained only limited use among pediatric ophthalmologists A definitive study comparing the outcomes from occlusion therapy and drug therapy is justified in order to determine if new practice guidelines for treatment of amblyopia are needed
Regardless of whether the trial determines that one therapeutic approach is better than the other the data that are collected will provide valuable information about the course of amblyopia treatment that is not presently available The study also is expected to provide data that will help to determine whether factors such as age refractive status cause of amblyopia or fixation pattern should be considered in determining which procedure is best for a given patient
Extended Follow-up of Study Patients
The extended follow up study consists of annual visits prior to age 10 followed by a visit at age 10 years and a visit at age 15 years There is no amblyopia treatment that is required during the extended follow up period
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 |
|---|---|---|---|
| 5U10EY011751 | NIH | None | httpsreporternihgovquickSearch5U10EY011751 |
| 2U10EY011751 | NIH | None | None |