Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-28 @ 5:44 PM
Study NCT ID:
NCT01123057
Status:
UNKNOWN
Last Update Posted:
2010-05-14
First Post:
2010-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia
Sponsor:
Singapore National Eye Centre
Organization:
Study Overview
Official Title:
Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia
Status:
UNKNOWN
Status Verified Date:
2010-05
Last Known Status:
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:
This is a hospital-based interventional prospective study. Patients with clinical keratoconus or LASIK keratectasia presenting to the Singapore National Eye Centre who meet the eligibility criteria are recruited for this study. The aim of the study is to assess the safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia
Detailed Description:
The purpose of this evaluation is to assess the safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia due to keratoconus and LASIK keratectasia. The principle of the procedure is to induce collagen crosslinking of the corneal stroma by the using riboflavin/UVA-treatment.
The technique involves topical application of riboflavin/dextran solution onto eye after removal of corneal epithelium. After initial riboflavin application for 30 minutes, UVA light is shone onto the cornea for another 30 minutes with continued topical riboflavin application.
A thorough examination is performed to evaluate the following pre-operatively:
* Manifest refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
* Cycloplegic refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
* Slit-lamp biomicroscopy and photography
* Intraocular pressure measurement
* Fundoscopy
* Corneal topography using Orbscan II and Pentacam
* Corneal aberrometry measurement using Technolas Zywave Aberrometer
* Endothelial cell count measurement using Konan noncontact endothelial cell analyser
* Confocal microscopy
* Corneal hysteresis measurement using Ocular Response Analyser
* Subjective feedback about quality of vision (VF 14 assessment) Post-operative Assessment (1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively)
* Uncorrected visual acuity and best corrected visual acuity with manifest refraction
* Cycloplegic refraction results - uncorrected visual acuity and best corrected visual acuity
* Subjective visual outcome rating
* Slit lamp examination and photography
* Fundoscopy
* Corneal topography
* Aberrometry measurement
* Endothelial cell count
* Confocal microscopy
* Corneal hysteresis measurement
* Report adverse events
The technique involves topical application of riboflavin/dextran solution onto eye after removal of corneal epithelium. After initial riboflavin application for 30 minutes, UVA light is shone onto the cornea for another 30 minutes with continued topical riboflavin application.
A thorough examination is performed to evaluate the following pre-operatively:
* Manifest refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
* Cycloplegic refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
* Slit-lamp biomicroscopy and photography
* Intraocular pressure measurement
* Fundoscopy
* Corneal topography using Orbscan II and Pentacam
* Corneal aberrometry measurement using Technolas Zywave Aberrometer
* Endothelial cell count measurement using Konan noncontact endothelial cell analyser
* Confocal microscopy
* Corneal hysteresis measurement using Ocular Response Analyser
* Subjective feedback about quality of vision (VF 14 assessment) Post-operative Assessment (1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively)
* Uncorrected visual acuity and best corrected visual acuity with manifest refraction
* Cycloplegic refraction results - uncorrected visual acuity and best corrected visual acuity
* Subjective visual outcome rating
* Slit lamp examination and photography
* Fundoscopy
* Corneal topography
* Aberrometry measurement
* Endothelial cell count
* Confocal microscopy
* Corneal hysteresis measurement
* Report adverse events
Study Oversight
Has Oversight DMC:
False
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?: