Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system. for Keratoconus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Arbor Center for Eye Care, Orland Park, ILKeratoconus+1 MoreEpithelial-on Corneal Crosslinking with the PXL 330 Platinum system. - CombinationProduct
Eligibility
12 - 60
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new device to treat corneal thinning. The goal is to see if it is safe and effective.

Eligible Conditions
  • Keratoconus

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 year

1 year
Best corrected visual acuity
Mean keratometry in diopters

Trial Safety

Trial Design

2 Treatment Groups

Conventional
1 of 2
Pulsed, accelerated
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system. · No Placebo Group · Phase 2

Pulsed, accelerated
CombinationProduct
Experimental Group · 1 Intervention: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system. · Intervention Types: CombinationProduct
Conventional
CombinationProduct
ActiveComparator Group · 1 Intervention: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system. · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Arbor Center for Eye CareLead Sponsor
David Lubeck, MDPrincipal InvestigatorArbor Center for Eye Care

Eligibility Criteria

Age 12 - 60 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Missouri100.0%
What site did they apply to?
Arbor Center for Eye Care100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
1100.0%

Frequently Asked Questions

How many individuals have enrolled for participation in this research endeavor?

"Affirmative. Clinicaltrials.gov confirms that this clinical research, which was originally advertised on July 8th 2020, is still actively enrolling participants. The study requires 100 individuals from a single location to participate in the trial." - Anonymous Online Contributor

Unverified Answer

What potential risks could patients encounter due to Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system?

"After careful analysis, our team at Power ranked Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system a 2 on safety. This is due to available data supporting its safety but no evidence of efficacy yet." - Anonymous Online Contributor

Unverified Answer

Does the criteria for inclusion in this trial encompass individuals over thirty years of age?

"This clinical trial is recruiting participants between the age of 12 and 60. Additionally, there are 45 trials for minors under 18 years old and 182 for seniors above 65." - Anonymous Online Contributor

Unverified Answer

Is my inclusion viable for this medical research project?

"To qualify for inclusion in this trial, applicants must have [keratoconus](https://www.withpower.com/clinical-trials/keratoconus) and fall between the age range of 12 to 60. Recruitment is expected to involve 100 patients." - Anonymous Online Contributor

Unverified Answer

Is it possible to enroll in this experimental trial at the moment?

"Currently, clinicaltrials.gov indicates that this medical trial is open to participants. The study was initially published on July 8th 2020 and has since been updated as recently as March 16th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.