Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000155
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-09-23
Brief Title:
The Collaborative Longitudinal Evaluation of Keratoconus CLEK Study
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2001-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 describe the clinical course of keratoconus and to describe the relationships among its visual and physiological manifestations including high- and low-contrast visual acuity corneal curvature slit lamp biomicroscopic findings corneal scarring and quality of life
To identify risk factors and protective factors that influence the severity and progression of keratoconus
To identify risk factors and protective factors that influence the severity and progression of keratoconus
Detailed Description:
Keratoconus is a bilateral asymmetric chronic progressive ectasia of the cornea characterized by steepening and distortion of the cornea thinning of the apical cornea corneal scarring and treatment-related sequelae such as abrasions from contact lenses and surgical complications Patients experience distorted vision that worsens with disease progression Their vision is typically corrected with spectacles early in the disease and later with rigid contact lenses Some patients eventually undergo corneal transplantation in one or both eyes Keratoconus affects people in their prime earning years and profoundly affects their lives
Previous large-scale studies of keratoconus have focused on incidence and prevalence etiologies or the clinical management of keratoconus Few have characterized the course of the disease and risk factors for its progression in large samples of keratoconus patients The incidence of vision-threatening corneal scarring in keratoconus is unknown Patients most frequent questions--how rapidly their keratoconus will progress how bad their vision will become whether they will need corneal surgery how successful their contact lenses will be--cannot be answered on the basis of the current body of knowledge
The need for a prospective observational study of keratoconus patients is great Results from this study will address keratoconus patients unanswered questions and will enable eye care practitioners to manage this complex ocular disease better
The Collaborative Longitudinal Evaluation of Keratoconus CLEK Study is a multicenter observational study of 1209 keratoconus patients followed for 3 years
Patients are examined annually Study measures include visual acuity patient-reported quality of life manifest refraction keratometry photodocumentation of the cornea to identify central corneal scarring photodocumentation of the flattest contact lens that just clears the cornea slit lamp biomicroscopy and corneal topography In rigid contact lens wearers the fluorescein pattern of the patients habitual contact lenses is photodocumented
Patients are examined at 15 clinical centers The clinical centers enrolled 1209 patients in 12 months
Previous large-scale studies of keratoconus have focused on incidence and prevalence etiologies or the clinical management of keratoconus Few have characterized the course of the disease and risk factors for its progression in large samples of keratoconus patients The incidence of vision-threatening corneal scarring in keratoconus is unknown Patients most frequent questions--how rapidly their keratoconus will progress how bad their vision will become whether they will need corneal surgery how successful their contact lenses will be--cannot be answered on the basis of the current body of knowledge
The need for a prospective observational study of keratoconus patients is great Results from this study will address keratoconus patients unanswered questions and will enable eye care practitioners to manage this complex ocular disease better
The Collaborative Longitudinal Evaluation of Keratoconus CLEK Study is a multicenter observational study of 1209 keratoconus patients followed for 3 years
Patients are examined annually Study measures include visual acuity patient-reported quality of life manifest refraction keratometry photodocumentation of the cornea to identify central corneal scarring photodocumentation of the flattest contact lens that just clears the cornea slit lamp biomicroscopy and corneal topography In rigid contact lens wearers the fluorescein pattern of the patients habitual contact lenses is photodocumented
Patients are examined at 15 clinical centers The clinical centers enrolled 1209 patients in 12 months
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