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

Phase 2

Terminated

• Conditions: Keratoconus
• Interventions: Drug: Riboflavin drops

• Registration Number: NCT02762253
• Lead Sponsor: Nvision Laser Eye Centers

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.

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Riboflavin drops - epithelium on or off	Riboflavin drops	Riboflavin is applied with Epithelium on or with it off. 6 months follow up to find out magnitude of Decrease in Kmax

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (11)

NVISION Fullerton; 🇺🇸 Fullerton, California, United States

NVISION Laguna Hills; 🇺🇸 Laguna Hills, California, United States

NVISION Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

NVISION Camarillo; 🇺🇸 Camarillo, California, United States

NVISION Sacramento; 🇺🇸 Citrus Heights, California, United States

Berg Feinfield Vision Center; 🇺🇸 Sherman Oaks, California, United States

NVISION La Jolla; 🇺🇸 San Diego, California, United States

NVISION Ontario; 🇺🇸 Ontario, California, United States

NVISION Newport Beach; 🇺🇸 Newport Beach, California, United States

NVISION Torrance; 🇺🇸 Torrance, California, United States

Teplick Custom Vision; 🇺🇸 Beaverton, Oregon, United States