Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
Cohen Laser and Vision Center
Study ID
NCT05516004
Phase
PHASE2
Status
Recruiting
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Conditions

  • Keratoconus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PXL Platinum 330 system — DEVICE
    to determine the efficacy of riboflavin solution and UV light to treat cornea thinning conditions

Study Details

This study study is to determine the effectiveness of cornea cross linking in patients with Keratoconus or other cornea thinning conditions.

Key Dates

Start date
Jul 1, 2024
Status verified
Jun 2024
Primary completion
Jun 1, 2034
Completion
Jun 1, 2034

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PXL 330
    Participants will receive riboflavin 0.25% solution (Peschke TE), one drop every minute for 25 minutes to the eye, followed by UVA light 9mW/cm2 continuous mode for 10 minutes

Primary Outcome Measure

Stability in maximum and mean keratometric diopters (Kmax) [ Time Frame: one year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cohen Laser and Vision CenterBoca RatonFlorida33431-1806
Joshua Cohen, MD
[email protected]
561-981-8400
GREGORY Cohen, MD
[email protected]
5614456824

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Cohen Laser and Vision Center· Boca Raton, FL

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