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

Primary Purpose

Keratoconus

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Riboflavin drops
Sponsored by
Nvision Laser Eye Centers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    1. Presence of central or inferior steepening on the Pentacam or Orbscan map consistent with Keratoconus.
    2. Axial topography consistent with keratoconus.
    3. 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:

    I. 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.

    4. 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.

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

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

    -

Sites / Locations

  • NVISION Camarillo
  • NVISION Sacramento
  • NVISION Fullerton
  • NVISION Laguna Hills
  • NVISION Newport Beach
  • NVISION Ontario
  • NVISION La Jolla
  • Berg Feinfield Vision Center
  • NVISION Torrance
  • NVISION Las Vegas
  • Teplick Custom Vision

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Riboflavin drops - epithelium on or off

Arm Description

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

Outcomes

Primary Outcome Measures

Keratometry
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

manifest refraction
The change in manifest refraction at 6 months compared to pre op
Visual Acuity
Change in BSCVA and UCVA compared to the baseline examination will be evaluated at 6 months postoperatively.
Central Pachymetry
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.

Full Information

First Posted
May 3, 2016
Last Updated
May 4, 2016
Sponsor
Nvision Laser Eye Centers
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1. Study Identification

Unique Protocol Identification Number
NCT02762253
Brief Title
Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
No IND submitted to the FDA
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nvision Laser Eye Centers

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Riboflavin drops - epithelium on or off
Arm Type
Other
Arm Description
Riboflavin is applied with Epithelium on or with it off. 6 months follow up to find out magnitude of Decrease in Kmax
Intervention Type
Drug
Intervention Name(s)
Riboflavin drops
Other Intervention Name(s)
Rincolin
Intervention Description
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
Primary Outcome Measure Information:
Title
Keratometry
Description
The change in maximum keratometry (Kmax) from baseline will be evaluated at 6 months for all eyes. Data will be summarized using descriptive statistics.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
manifest refraction
Description
The change in manifest refraction at 6 months compared to pre op
Time Frame
6 months
Title
Visual Acuity
Description
Change in BSCVA and UCVA compared to the baseline examination will be evaluated at 6 months postoperatively.
Time Frame
6 months
Title
Central Pachymetry
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA GENERAL: 12 years of age or older Signed written informed consent Willingness and ability to comply with schedule for follow-up visits Contact lens removal prior to evaluation and treatment Candidates must also have two of the following criteria: Presence of central or inferior steepening on the Pentacam or Orbscan map consistent with Keratoconus. Axial topography consistent with keratoconus. Steepest keratometry (Kmax) value of 47.00D INCLUSION CRITERIA FOR ECTASIA: History of having undergone a keratorefractive procedure and 2 of the following criteria: Steepening by topography, either Pentacam or Orbscan Thinning of cornea Shift in the position of thinnest portion of cornea Change in refraction with increasing myopia Development of myopic astigmatism Development of irregular astigmatism Loss of BSCVA EXCLUSION CRITERIA: I. 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. 4. 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. 9. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment. 10. Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tom s tooma, md
Organizational Affiliation
NVISION Eye Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
NVISION Camarillo
City
Camarillo
State/Province
California
ZIP/Postal Code
93010
Country
United States
Facility Name
NVISION Sacramento
City
Citrus Heights
State/Province
California
ZIP/Postal Code
95621
Country
United States
Facility Name
NVISION Fullerton
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Facility Name
NVISION Laguna Hills
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
NVISION Newport Beach
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
NVISION Ontario
City
Ontario
State/Province
California
ZIP/Postal Code
91764
Country
United States
Facility Name
NVISION La Jolla
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Berg Feinfield Vision Center
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91423
Country
United States
Facility Name
NVISION Torrance
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
NVISION Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Teplick Custom Vision
City
Beaverton
State/Province
Oregon
ZIP/Postal Code
97008
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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