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

Stopped early · Phase 2

Conditions studied: Keratoconus

In brief

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.

Key facts

Study ID

NCT02762253

Run by

Nvision Laser Eye Centers

People needed

320

Starts

2012-09-01

Expected to finish

2016-04-01

Last updated by the study team

2016-05-05

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• NVISION Camarillo — Camarillo, California, United States
• NVISION Sacramento — Citrus Heights, California, United States
• NVISION Fullerton — Fullerton, California, United States
• NVISION Laguna Hills — Laguna Hills, California, United States
• NVISION Newport Beach — Newport Beach, California, United States
• NVISION Ontario — Ontario, California, United States
• NVISION La Jolla — San Diego, California, United States
• Berg Feinfield Vision Center — Sherman Oaks, California, United States
• NVISION Torrance — Torrance, California, United States
• NVISION Las Vegas — Las Vegas, Nevada, United States
• Teplick Custom Vision — Beaverton, Oregon, United States

Full record on ClinicalTrials.gov

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