Clincosm LogoSign in Get a demo

Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.

Sponsor
Nvision Laser Eye Centers (Industry)
Overall Status
Terminated
CT.gov ID
NCT02762253
Collaborator
(none)
320
Enrollment
11
Locations
1
Arm
43
Duration (Months)
29.1
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is being conducted to assess the safety and effectiveness of photochemically induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and Ecstasia.

Condition or Disease Intervention/Treatment Phase
  • Drug: Riboflavin drops
 Phase 2

Detailed Description

Riboflavin drops are used every 2 minutes for 30+ minutes until the corneal stroma is saturated with Riboflavin as evidenced by observing Riboflavin in the Anterior chamber. Two arms in the study, one uses Riboflavin with Epithelium on and the other with Epithelium off. Once it is observed that the Riboflavin has penetrated the stroma and is seen in the anterior chamber, the cornea is exposed to Ultraviolet light at an irradiance level of 18mW/cm2 for 5 minutes. A contact lens is applied until the epithelium has fully healed in 3 to 5 days. The study is for 6 months. The corneal curvature as well as the uncorrected and best corrected vision and corneal thickness are evaluated pre-operatively and at 6 months. The primary variable that is assessed to determine the efficacy of the drug is the Kmax - Steep corneal curvature. Secondary effectiveness criteria are uncorrected and best corrected vision and corneal thickness. adverse events are also monitored.

Study Design

Study Type:
Interventional
Actual Enrollment :
320 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irrandiance of 18 mW/cm2 in Eyes With Keratoconus or Ectasia.
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Riboflavin drops - epithelium on or off

Riboflavin is applied with Epithelium on or with it off. 6 months follow up to find out magnitude of Decrease in Kmax

Drug: Riboflavin drops
Riboflavin drops were used every 2 minutes for 30 minutes on the cornea then exposed to 5 minutes of Ultraviolet light at an intensity of 18mW/cm2
Other Names:
  • Rincolin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Keratometry [6 months]

      The change in maximum keratometry (Kmax) from baseline will be evaluated at 6 months for all eyes. Data will be summarized using descriptive statistics.

    Secondary Outcome Measures

    1. manifest refraction [6 months]

      The change in manifest refraction at 6 months compared to pre op

    2. Visual Acuity [6 months]

      Change in BSCVA and UCVA compared to the baseline examination will be evaluated at 6 months postoperatively.

    3. Central Pachymetry [6 months]

      The change in central pachymetry (as measured by Pentacam) from baseline will be evaluated at 6 months postoperatively. Data will be summarized using descriptive statistics.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    INCLUSION CRITERIA GENERAL:

    1. 12 years of age or older

    2. Signed written informed consent

    3. Willingness and ability to comply with schedule for follow-up visits

    4. Contact lens removal prior to evaluation and treatment

    5. Candidates must also have two of the following criteria:

    6. Presence of central or inferior steepening on the Pentacam or Orbscan map consistent with Keratoconus.

    7. Axial topography consistent with keratoconus.

    8. Steepest keratometry (Kmax) value of 47.00D

    INCLUSION CRITERIA FOR ECTASIA:
    History of having undergone a keratorefractive procedure and 2 of the following criteria:

    1. Steepening by topography, either Pentacam or Orbscan

    2. Thinning of cornea

    3. Shift in the position of thinnest portion of cornea

    4. Change in refraction with increasing myopia

    5. Development of myopic astigmatism

    6. Development of irregular astigmatism

    7. Loss of BSCVA

    EXCLUSION CRITERIA:
    1. Eyes classified as either normal or atypical normal 2. Corneal pachymetry 350 microns at the thinnest point measured by Pentacam in the eye to be treated 3. A history of chemical injury or delayed epithelial healing in the eye to be treated.

    1. Pregnancy (including plan to become pregnant) or lactation during the course of the study 5. A known sensitivity to study medications 6. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment 7. Inability to cooperate with diagnostic tests. 8. Patients with a concomitant condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.

    2. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.

    3. Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NVISION Camarillo Camarillo California United States 93010
    2 NVISION Sacramento Citrus Heights California United States 95621
    3 NVISION Fullerton Fullerton California United States 92831
    4 NVISION Laguna Hills Laguna Hills California United States 92653
    5 NVISION Newport Beach Newport Beach California United States 92660
    6 NVISION Ontario Ontario California United States 91764
    7 NVISION La Jolla San Diego California United States 92122
    8 Berg Feinfield Vision Center Sherman Oaks California United States 91423
    9 NVISION Torrance Torrance California United States 90505
    10 NVISION Las Vegas Las Vegas Nevada United States 89119
    11 Teplick Custom Vision Beaverton Oregon United States 97008

    Sponsors and Collaborators

    • Nvision Laser Eye Centers

    Investigators

    • Principal Investigator: tom s tooma, md, NVISION Eye Centers

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nvision Laser Eye Centers
    ClinicalTrials.gov Identifier:
    NCT02762253
    Other Study ID Numbers:
    • NV001
    First Posted:
    May 4, 2016
    Last Update Posted:
    May 5, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Keratoconus
    Riboflavin

    Study Results

    No Results Posted as of May 5, 2016