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Evaluating the Safety and Efficacy of the KXL System for Corneal Collagen Cross-Linking in Eyes Having Keratoconus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638376
Recruitment Status : Unknown
Verified December 2015 by Lim Li, Singapore Eye Research Institute.
Recruitment status was:  Recruiting
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Lim Li, Singapore Eye Research Institute

Brief Summary:

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:

  1. Keratoconus (KC) ,
  2. Post LASIK ectasia (PLEc)

Condition or disease Intervention/treatment Phase
Keratoconus Post LASIK Keratectasia Radiation: 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid) Procedure: simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK) Phase 3

Detailed Description:

KC and Plec eyes Group 1 (non-randomised controlled)

Eyes will be assigned into 2 groups:

  • Treatment eyes group with KXL
  • Control eyes group (fellow eye) The Treatment eyes will be cross linked with the KXL system and the vibeX Rapid Riboflavin, while the control eyes will not receive any treatment.

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:

  • Treatment group with simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)
  • Control eyes group (fellow eye) The Treatment eyes will undergo simultaneous topography-guided PRK and be cross linked with the KXL system and the vibeX Rapid Riboflavin, while the control eyes will not receive any treatment.

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016


Arm Intervention/treatment
Active Comparator: KXL treatment only Radiation: 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid)

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.


Active Comparator: KXL and topography-guided PRK
simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)
Radiation: 0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid)

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.


Procedure: simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)

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.





Primary Outcome Measures :
  1. Safety Measure: Change in Best Corrected Visual Acuity (LogMAR) at 6 months and 1 year [ Time Frame: 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

  2. Safety measure: change in endothelial cell counts(cells/mm2) at 6 months and 1 year [ Time Frame: 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

  3. Efficacy measure: Change in Corneal keratometry measurement, Kmax(D) at 6 months and 1 year [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age Limit for for keratoconus and Plec:18 years
  2. Sign the informed consent.
  3. Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
  4. Contact Lens Wearers Only:

    Minimum of 3 days

  5. For KC subjects:

    1. Axial topography consistent with keratoconus(Pentacam )
    2. Presence of central or inferior steepening on the Pentacam map;
    3. Steepest keratometry (Kmax) value ≥ 47.00 D;
    4. May have corneal scarring up to and including CLEK grade 4.0 (any scarring up to a dense/opaque stromal scar consistent with KC)
    5. Keratoconus progressing over time ( evidenced by topography changes, visual acuity or refractive changes)
  6. For PLEc subjects:

    1. Having a diagnosis of corneal ectasia after corneal refractive surgery (e.g., LASIK, PRK, epi-LASIK,LASEK,)
    2. Presence of central or inferior steepening on the Pentacam map.
    3. Axial topography consistent with corneal ectasia

Exclusion Criteria:

  1. Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
  2. 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;
  3. 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;
  4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated;
  5. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
  6. Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing;
  7. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment,retinoic acid within 6 months of treatment
  8. 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;

  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638376


Contacts
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Contact: Chuan Teck Ang, Diploma ang.chuan.teck@seri.com.sg
Contact: Mohamed Farook Kothubutheen, BSc (Hons) farook@snec.com.sg

Locations
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Singapore
Singapore National Eye Centre Recruiting
Singapore, Singapore, 168751
Contact: Chuan Teck Ang, Diploma       ang.chuan.teck@seri.com.sg   
Contact: Mohamed Farook Kothubutheen, BSc (Hons)       farook@snec.com.sg   
Principal Investigator: Li Lim, MBBS,FRCS         
Sub-Investigator: Tiang Hwee, Donald Tan, MBBS,FRCS         
Sub-Investigator: Jodhbir S Mehta, MBBS,FRCS         
Sub-Investigator: Mei Lan, Cordelia Chan, MBBS,FRCS         
Sub-Investigator: Seng Ei Ti, MBBS,FRCS         
Sponsors and Collaborators
Singapore Eye Research Institute
Investigators
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Principal Investigator: Li Lim, MBBS, FRCS Singapore National Eye Centre, Singapore Eye Research Institute
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Responsible Party: Lim Li, A/Prof, Singapore Eye Research Institute
ClinicalTrials.gov Identifier: NCT02638376    
Other Study ID Numbers: R963/72/2012
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Keywords provided by Lim Li, Singapore Eye Research Institute:
Keraroconus
keratectasia
treatment
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases
Riboflavin
Ophthalmic Solutions
Pharmaceutical Solutions
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents