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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Keratoconus
• Intervention / Treatment: Drug: Riboflavin drops

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 Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Camarillo, California, United States, 93010
      • NVISION Camarillo
    • Citrus Heights, California, United States, 95621
      • NVISION Sacramento
    • Fullerton, California, United States, 92831
      • NVISION Fullerton
    • Laguna Hills, California, United States, 92653
      • NVISION Laguna Hills
    • Newport Beach, California, United States, 92660
      • NVISION Newport Beach
    • Ontario, California, United States, 91764
      • NVISION Ontario
    • San Diego, California, United States, 92122
      • NVISION La Jolla
    • Sherman Oaks, California, United States, 91423
      • Berg Feinfield Vision Center
    • Torrance, California, United States, 90505
      • NVISION Torrance
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • NVISION Las Vegas
  • Oregon
    • Beaverton, Oregon, United States, 97008
      • Teplick Custom Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

   -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
manifest refraction	The change in manifest refraction at 6 months compared to pre op	6 months
Visual Acuity	Change in BSCVA and UCVA compared to the baseline examination will be evaluated at 6 months postoperatively.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Nvision Laser Eye Centers
• Investigators: Principal Investigator: tom s tooma, md, NVISION Eye Centers

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Riboflavin
• Other Study ID Numbers: NV001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided