MedTrace Logo

Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2

NCT02009709 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-12-14

No results posted yet for this study

Summary

The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.

Conditions

  • Keratoconus
  • Corneal Ectasia

Interventions

DRUG

Riboflavin 0.1% ophthalmic solution

Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure.

DEVICE

CCL-VARIO UV lamp

Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes

DEVICE

CCL-VARIO at 18 mW/cm2

Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.

Sponsors & Collaborators

  • Robert Mack, M.D.

    lead OTHER

Principal Investigators

  • Robert J Mack, M.D. · Mack Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02009709 on ClinicalTrials.gov