Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000113
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
1999-09-23
Brief Title:
Correction of Myopia Evaluation Trial COMET
Sponsor:
Stony Brook University
Organization:
Stony Brook University
Study Overview
Official Title:
Correction of Myopia Evaluation Trial COMET
Status:
COMPLETED
Status Verified Date:
2016-04
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 evaluate whether progressive addition lenses PALs slow the rate of progression of juvenile-onset myopia nearsightedness when compared with single vision lenses as measured by cycloplegic autorefraction An additional outcome measure is axial length as measured by A-scan ultrasonography
To describe the natural history of juvenile-onset myopia in a group of children receiving conventional treatment single vision lenses
To describe the natural history of juvenile-onset myopia in a group of children receiving conventional treatment single vision lenses
Detailed Description:
Myopia nearsightedness is an important public health problem which entails substantial societal and personal costs It is highly prevalent in our society and even more frequent in Asian countries furthermore its prevalence may be increasing over time High myopia contributes to significant loss of vision and blindness At present the mechanisms involved in the etiology of myopia are unclear and there is no way to prevent the condition Current methods of correction require lifelong use of lenses or surgical treatment which is expensive and may lead to complications The rationale for this trial the Correction of Myopia Evaluation Trial COMET arises from the convergence of research involving 1 the link between accommodation and myopia in children and 2 animal models of myopia showing the important role of the visual environment in eye growth A contribution of this research is that blur is a critical component in the development of myopia The primary aim of COMET to evaluate the efficacy of progressive addition lenses a noninvasive intervention in slowing the progression of myopia follows from this line of reasoning These lenses should provide clear visual input over a range of viewing distances without focusing effort by the child The comparison of myopia progression in children treated with PALs versus single vision lenses will allow the quantification of the effect of PALs on myopia progression during the followup period
The COMET is a multicenter randomized double-masked clinical trial to evaluate whether PALs slow the progression of juvenile-onset myopia as compared with single vision lenses The study is a collaborative effort that involves a Study Chair at the New England College of Optometry four clinical centers at colleges of optometry in Boston Birmingham Philadelphia and Houston and a Coordinating Center at the State University of New York at Stony Brook
The sample size goal 450 children with myopia in both eyes who met specific inclusion and exclusion criteria was attained with the enrollment of 469 children in one year Children were identified from school screenings clinic records and referrals from local practitioners Eligible children were randomly assigned to receive progressive addition or single vision lenses Participating children are being examined at 6-month intervals following baseline for at least 3 years to measure changes in refractive error and to update prescriptions according to a specified protocol A dilated examination to evaluate the study outcome measures is performed at the annual study visits A standardized common protocol is used at all centers
The primary outcome of the study is progression of myopia defined as the magnitude of the change relative to baseline in spherical equivalent refraction determined by cycloplegic autorefraction The secondary outcome of the study is axial length measured by A-scan ultrasonography
The COMET is a multicenter randomized double-masked clinical trial to evaluate whether PALs slow the progression of juvenile-onset myopia as compared with single vision lenses The study is a collaborative effort that involves a Study Chair at the New England College of Optometry four clinical centers at colleges of optometry in Boston Birmingham Philadelphia and Houston and a Coordinating Center at the State University of New York at Stony Brook
The sample size goal 450 children with myopia in both eyes who met specific inclusion and exclusion criteria was attained with the enrollment of 469 children in one year Children were identified from school screenings clinic records and referrals from local practitioners Eligible children were randomly assigned to receive progressive addition or single vision lenses Participating children are being examined at 6-month intervals following baseline for at least 3 years to measure changes in refractive error and to update prescriptions according to a specified protocol A dilated examination to evaluate the study outcome measures is performed at the annual study visits A standardized common protocol is used at all centers
The primary outcome of the study is progression of myopia defined as the magnitude of the change relative to baseline in spherical equivalent refraction determined by cycloplegic autorefraction The secondary outcome of the study is axial length measured by A-scan ultrasonography
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 |
|---|---|---|---|
| U10EY011756 | NIH | None | httpsreporternihgovquickSearchU10EY011756 |