Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274664
Status:
COMPLETED
Last Update Posted:
2006-01-11
First Post:
2006-01-09
Brief Title:
Patching for Lazy Eye Trial to Evaluate Daily Patching Amounts
Sponsor:
City University of London
Organization:
City University of London
Study Overview
Official Title:
Randomised Occlusion Treatment of Amblyopia Study ROTAS Trial of Maximal Vs Substantial Doses of Occlusion to Evaluate Visual Outcome for Children With Amblyopia
Status:
COMPLETED
Status Verified Date:
2005-12
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:
Amblyopia lazy eye is the commonest visual disorder of childhood and is caused by an interruption to visual development Occlusion of the better eye by patching is the mainstay of treatment so forcing use of the affected eye We have little understanding of how much treatment is required for improvement so occlusion may continue for many months This is both demanding for the child and family as a whole Treatment outcome is frequently unsatisfactory Compliance is often poor thus we do not know precisely how much treatment the child actually receives or how much is required
To overcome this we have designed an instrument that permits us to measure occlusion an occlusion dose monitor ODM which provides an objective record of how much occlusion a child actually receives Recently we have observed that 75 of improvement induced by occlusion occurs in the first four weeks of treatment In this study we explore the possibility that by intensive treatment the period of amblyopia therapy can be shortened - ie treatment will be more efficient more effective and more family-friendly The study hypothesis is that 12 hoursday of patching is more effective than 6 hoursday
To overcome this we have designed an instrument that permits us to measure occlusion an occlusion dose monitor ODM which provides an objective record of how much occlusion a child actually receives Recently we have observed that 75 of improvement induced by occlusion occurs in the first four weeks of treatment In this study we explore the possibility that by intensive treatment the period of amblyopia therapy can be shortened - ie treatment will be more efficient more effective and more family-friendly The study hypothesis is that 12 hoursday of patching is more effective than 6 hoursday
Detailed Description:
The identification and subsequent management of amblyopia are major consumers of health service resource and within the hospital sector account for around 80-90 of visits to the childrens eye service Occlusion of the better eye is the mainstay of treatment and because we have little understanding of the dose-response relationship this may continue for many months and sometimes for many hundreds of hours This is demanding for the child and family as a whole and yet the outcome is frequently unsatisfactory Currently there is no reliable data on the kinetics of visual improvement so occlusion tends to be prescribed on an ad hoc basis Recent pilot research has shown that 75 of the treatment-generated improvement occurs within the first 4 weeks when 6 hoursday occlusion is prescribed
In this study we explore the possibility that by intensive treatment the period of amblyopia therapy can be shortened - ie made both more efficient and hopefully more effective The purpose of the present study the Randomized Occlusion Treatment of Amblyopia Study ROTAS is to compare two frequently employed patching regimens substantial 6 hrsday against maximal 12 hrsday patching Our experimental design incorporates objective occlusion monitoring and is able to discriminate the beneficial effect of refractive correction from that of occlusion The study comprises three phases baseline refractive adaptation and occlusion Our aim is to provide guidelines for patient management based for the first time on experimentally determined and statistically verifiable relationships between treatment and outcome
In this study we explore the possibility that by intensive treatment the period of amblyopia therapy can be shortened - ie made both more efficient and hopefully more effective The purpose of the present study the Randomized Occlusion Treatment of Amblyopia Study ROTAS is to compare two frequently employed patching regimens substantial 6 hrsday against maximal 12 hrsday patching Our experimental design incorporates objective occlusion monitoring and is able to discriminate the beneficial effect of refractive correction from that of occlusion The study comprises three phases baseline refractive adaptation and occlusion Our aim is to provide guidelines for patient management based for the first time on experimentally determined and statistically verifiable relationships between treatment and outcome
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 |
|---|---|---|---|
| Fight for Sight 20500 | None | None | None |