Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347074
Status:
COMPLETED
Last Update Posted:
2006-07-07
First Post:
2006-06-30
Brief Title:
A Clinical Study of Keratoconus in Asian Patients and Assessment of Different Topographic Patterns of Keratoconus in Asian Patients
Sponsor:
Singapore National Eye Centre
Organization:
Singapore National Eye Centre
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-09
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:
A clinical study of keratoconus in Asian Patients and assessment of different topographic patterns of keratoconus in Asian patients
Detailed Description:
This hospital-based observational prospective study was designed to describe the characteristics of patients with keratoconus in an Asian population Patients with keratoconus and keratoconus suspects presenting to the Singapore National Eye Centre who met the eligibility criteria are were recruited for this study The following data were assessed
1 Demographic characteristics of patients with keratoconus
2 Quality of life assessment in patients with keratoconus
3 Visual Outcome and management of keratoconus in terms of contact lens fitting
4 Corneal topographic patterns of patients with keratoconus
5 Aberrometry studies with regards to diagnosis of keratoconus and quality of vision in patients with keratoconus
The patients not wearing contact lenses completed the study within one visit whereas the patients wearing contact lenses required 2 visits one with contact lens wear and one without contact lens wear to complete the study For patients wearing contact lenses they were advised to stop soft or rigid contact lens wear for 3 days before the initial visual acuity subjective refraction keratometry Tomey and Orbscan II topography examinations and Wavefront aberrometry tests were performed
Informed consent was obtained from all subjects after the nature of the study had been fully explained The study gained approval from the Ethics Committee of the Singapore Eye Research Institute
Each study participant was asked to answer the demography questionnaire form regarding their daily habit medical history economic and educational level and vision-related quality of life and the Visual Function Index VF-14
Visual acuity was assessed in each eye using a logMAR chart The visual acuity with manifest refraction was deemed the best corrected visual acuityBCVA for those patients who did not wear contact lenses and the visual acuity with over-refraction refraction over their contact lenses for contact lens wearers
Contrast sensitivity was examined only in patients with their habitual contact lenses in each eye using the Vision Contrast Test System VCTS chart VCTS 6500 contrast sensitivity Chart in 6 spatial frequencies
Slit lamp evaluation and contact lens fit assessment were performed Type of contact lens wear was recorded
Corneal topography was performed using Tomey keratoconus screening system Topographic Modeling System software version 242J without pupil dilation and without contact lens wear and the Orbscan II corneal topography system Bausch Lomb Surgical
Ocular wavefront aberrations were measured across the central 6-mm dilated pupil 1 Tropicamide of each eye with the Bausch and Lomb Technolas Zywave aberrometer with Zywave software version 445 ZYOPTIX Diagnostic Workstation Bausch Lomb
1 Demographic characteristics of patients with keratoconus
2 Quality of life assessment in patients with keratoconus
3 Visual Outcome and management of keratoconus in terms of contact lens fitting
4 Corneal topographic patterns of patients with keratoconus
5 Aberrometry studies with regards to diagnosis of keratoconus and quality of vision in patients with keratoconus
The patients not wearing contact lenses completed the study within one visit whereas the patients wearing contact lenses required 2 visits one with contact lens wear and one without contact lens wear to complete the study For patients wearing contact lenses they were advised to stop soft or rigid contact lens wear for 3 days before the initial visual acuity subjective refraction keratometry Tomey and Orbscan II topography examinations and Wavefront aberrometry tests were performed
Informed consent was obtained from all subjects after the nature of the study had been fully explained The study gained approval from the Ethics Committee of the Singapore Eye Research Institute
Each study participant was asked to answer the demography questionnaire form regarding their daily habit medical history economic and educational level and vision-related quality of life and the Visual Function Index VF-14
Visual acuity was assessed in each eye using a logMAR chart The visual acuity with manifest refraction was deemed the best corrected visual acuityBCVA for those patients who did not wear contact lenses and the visual acuity with over-refraction refraction over their contact lenses for contact lens wearers
Contrast sensitivity was examined only in patients with their habitual contact lenses in each eye using the Vision Contrast Test System VCTS chart VCTS 6500 contrast sensitivity Chart in 6 spatial frequencies
Slit lamp evaluation and contact lens fit assessment were performed Type of contact lens wear was recorded
Corneal topography was performed using Tomey keratoconus screening system Topographic Modeling System software version 242J without pupil dilation and without contact lens wear and the Orbscan II corneal topography system Bausch Lomb Surgical
Ocular wavefront aberrations were measured across the central 6-mm dilated pupil 1 Tropicamide of each eye with the Bausch and Lomb Technolas Zywave aberrometer with Zywave software version 445 ZYOPTIX Diagnostic Workstation Bausch Lomb
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