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The objectives of this study are to evaluate the safety of and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes having:
KC and Plec eyes Group 1 (non-randomised controlled)
Eyes will be assigned into 2 groups:
The safety and efficacy endpoints will be evaluated and compared between the Treatment eye group and the Control eye group.
After 6 months of follow up the KC and PLEc subjects will be offered to treat the control eyes if indicated.
Group 2 (non-randomised controlled combined treatment)
Eyes will be assigned into 2 groups:
The safety and efficacy endpoints will be evaluated and compared between the Treatment eye group and the Control eye group.
After 6 months of follow up the KC and PLEc subjects will be offered to treat the control eyes if indicated.
The concentrations of Riboflavin Ophthalmic Solution will be tested - 0.1% Riboflavin ophthalmic solution
KC Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous treatment or 8 minutes pulse treatment: 1 second on 1 second off.
PLEc Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous treatment or 8 minutes pulse treatment: 1 second on 1 second off..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KXL treatment only | Active Comparator |
| |
| KXL and topography-guided PRK | Active Comparator | simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid) | Radiation | KC Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous or 8 minutes pulse treatment: 1 second on 1 second off. PLEc Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous or 8 minutes pulse treatment: 1 second on 1 second off. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Measure: Change in Best Corrected Visual Acuity (LogMAR) at 6 months and 1 year | A study evaluating the safety and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes having Keratoconus and post LASIK ectasia | 6 months and 1 year |
| Safety measure: change in endothelial cell counts(cells/mm2) at 6 months and 1 year | A study evaluating the safety and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-linking in eyes having keratoconus and LASIK ectasia | 6 months and 1 year |
| Efficacy measure: Change in Corneal keratometry measurement, Kmax(D) at 6 months and 1 year | A study evaluating the safety and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-linking in eyes having keratoconus and LASIK ectasia | 6 months and 1 year |
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Inclusion Criteria:
Age Limit for for keratoconus and Plec:18 years
Sign the informed consent.
Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
Contact Lens Wearers Only:
Minimum of 3 days
For KC subjects:
For PLEc subjects:
Exclusion Criteria:
Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to randomization or during the course of the study;
For KC and PLEc subjects, corneal pachymetry that is < 400microns prior to epithelial debridement at the thinnest point measured by Pentacam in the eye to be treated;
A history of chemical injury or delayed epithelial healing in the eye(s) to be treated;
Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing;
Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment,retinoic acid within 6 months of treatment
Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:
8.1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.); 8.2. Clinically significant corneal scarring in the cross-linking treatment zone or in the investigator's opinion, will interfere with the cross-linking procedure;
For KC subjects 9.1. Eyes which are aphakic; 9.2. Eyes that have the maximum corneal curvature (Kmax), as identified and measured by Pentacam, outside of the central 5mm zone; Note: In addition, the Investigator may exclude or discontinue any subject for any sound medical reason.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuan Teck Ang, Diploma | Contact | ang.chuan.teck@seri.com.sg | ||
| Mohamed Farook Kothubutheen, BSc (Hons) | Contact | farook@snec.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Li Lim, MBBS, FRCS | Singapore National Eye Centre, Singapore Eye Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore National Eye Centre | Recruiting | Singapore | Singapore | 168751 | Singapore |
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| simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK) | Procedure | The (Partial, Spherically Corrected) Topography-guided Transepithelial PRK Technique. Is performed with WaveLight® EX 500 excimer laser (Alcon Laboratories Inc, Ft Worth, Texas) customized platform. This software utilizes topographic data from the linked topography device (Topolyzer; Wave- Light GmbH, Erlangen, Germany). The image of the planned surgery is generated by the laser software. The topography-guided PRK is used to normalize the cornea by reducing irregular astigmatism while treating part of the refractive error. The maximum ablation depth of stromal ablation is set at 50um. A 6.5-mm, 50-μm phototherapeutic keratectomy (PTK) was performed to remove the corneal epithelium. Partial topography- guided PRK laser treatment was applied. A cellulose sponge soaked in mitomycin C (MMC) 0.02% solution was applied over the ablated tissue for 20 seconds followed by irrigation with 10 mL of chilled balanced salt solution. |
|
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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