NCT02762253

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2012

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

3.6 years

First QC Date

May 3, 2016

Last Update Submit

May 4, 2016

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • manifest refraction

    6 months

  • Visual Acuity

    6 months

  • Central Pachymetry

    6 months

Study Arms (1)

Riboflavin drops - epithelium on or off

OTHER

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

Interventions

Riboflavin dropsDRUG

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

Also known as: Rincolin
Riboflavin drops - epithelium on or off

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +1 more criteria

You may not qualify if:

  • 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.
  • \. 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.
  • \. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
  • \. Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

NVISION Camarillo

Camarillo, California, 93010, United States

Location

NVISION Sacramento

Citrus Heights, California, 95621, United States

Location

NVISION Fullerton

Fullerton, California, 92831, United States

Location

NVISION Laguna Hills

Laguna Hills, California, 92653, United States

Location

NVISION Newport Beach

Newport Beach, California, 92660, United States

Location

NVISION Ontario

Ontario, California, 91764, United States

Location

NVISION La Jolla

San Diego, California, 92122, United States

Location

Berg Feinfield Vision Center

Sherman Oaks, California, 91423, United States

Location

NVISION Torrance

Torrance, California, 90505, United States

Location

NVISION Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Teplick Custom Vision

Beaverton, Oregon, 97008, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • tom s tooma, md

    NVISION Eye Centers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 4, 2016

Study Start

September 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

US(11)