CompletedPhase 1

Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

United States200 participantsStarted 2020-01-10

Plain-language summary

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions

Age range8 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 8 years of age or older
✓. Signed written informed consent
✓. Willingness and ability to comply with schedule for follow-up visits
✓. Contact Lens Wearers Only:
✓. Removal of contact lenses for the required period of time prior to the screening refraction:
✓. Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
✓. Presence of central or inferior steepening.
✓. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration

K-Max

Timeframe: 12 Months

K-Mean

Timeframe: 12 Months

NCT IDNCT04177082

SponsorCornea Associates of Texas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-05