A Phase 2 interventional study of PXL Platinum 330 system in Keratoconus, sponsored by Cohen Laser and Vision Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by Cohen Laser and Vision Center · Phase 2, Interventional, and Treatment
This study study is to determine the effectiveness of cornea cross linking in patients with Keratoconus or other cornea thinning conditions.
This study is an investigator initiated single center study that will be conducted over 10 years. Up to 300 patients with cornea thinning conditions will be enrolled. This is a prospective, single-arm, nonrandomized single site study to determine the safety and effectiveness of the PXL Platinum 330 system for performing collagen cross linking (CXL) in eyes with cornea thinning. Subjects with a history of keratoconus, pellucid marginal degeneration, thin corneas undergoing LASIK, PRK or INTACS will be evaluated for suitability as a candidate for CXL. Subjects that are candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine eligibility. Informed consent will be obtained from each subject before performing any study procedures.
Eyes undergoing CXL will have topical anesthetic administered and then have topical riboflavin instilled on the cornea for 25 minutes, followed by UVA light 9mW/cm2 for 10 minutes. The CXL procedures will be performed on an outpatient basis using the PXL Platinum 330 System (UVA light source with riboflavin solution). All use of the PXL Platinum 330 System will be in accordance with this protocol and the general instructions provided be the manufacturer in the PXL Platinum 330 operator's manual.
All subjects will be evaluated at screening/baseline, Day 0 (treatment day), 1 day, 1 week and 1,3,6 and 12 months after treatment. Topographic keratometry, posterior cornea measurements (with Pentacam), cornea topography, manifest refraction, and measurements of best spectacle corrected visual acuity and intraocular pressure will be obtained at baseline and appropriate times after the CXL treatment. Safety monitoring throughout the study will include observations for subjective complaints, complications, adverse events, clinically significant findings on ophthalmic examination, dilated fundus examination and slit-lamp examination. Quality of vision and subjective complaints will be evaluated preoperatively and postoperatively with a vision related quality of life questionnaire.
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 300 is above the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →This is the only study on the registry with Cohen Laser and Vision Center as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study:
Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam such as:
Contact Lens Wearers Only:
Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid gas permeable 2 Weeks per decade of wear
Exclusion Criteria:
All subjects meeting any of the following criteria will be excluded from this study:
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: PXL Platinum 330 system
to determine the efficacy of riboflavin solution and UV light to treat cornea thinning conditions
Stability in maximum and mean keratometric diopters (Kmax)
As measured by Pentacam tomographer (Oculus)
Time frame: one year
Change in Belin-Ambrosio ectasia score
As measured by Pentacam tomographer (Oculus)
Time frame: one year
Pachymetry or corneal thickness (microns)
As measured by Pentacam tomographer or ultrasound pachymeter
Time frame: one year
Change in best corrected visual acuity
both spectacle and contact lens acuity, if needed
Time frame: one year
change in astigmatism degree or axis
as measured by manifest refraction and keratometric astigmatism (Ks) per Pentacam
Time frame: one year
Plan to share: No
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