Safety Study of the VEGA UV-A System to Treat Keratoconus

Launched by TOPCON MEDICAL SYSTEMS, INC. · Aug 25, 2010

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 12 years of age or older
• • Having a diagnosis of keratoconus
• • Presence of central or inferior steepening
• • Topography consistent with keratoconus
• • Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
• • Contact lens wearers only:Removal of contact lenses for the required period of time
• • Signed written informed consent
• • Willingness and ability to comply with schedule for follow-up visits
• Exclusion Criteria:
• • For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated
• • Corneal pachymetry ≤ 400 microns
• • Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
• • A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
• • Pregnancy (including plan to become pregnant) or lactation during the course of the study
• • A known sensitivity to study medications
• • Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
• • A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
• • Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.