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

NCT05516004 | Recruiting Phase 2 DMC

• 1 other identifier: CohenLaser
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (2)

• Stability in maximum and mean keratometric diopters (Kmax)

  As measured by Pentacam tomographer (Oculus)

  one year

• Change in Belin-Ambrosio ectasia score

  As measured by Pentacam tomographer (Oculus)

  one year

Secondary Outcomes (3)

• Pachymetry or corneal thickness (microns)

  one year

• Change in best corrected visual acuity

  one year

• change in astigmatism degree or axis

  one year

Study Arms (1)

PXL 330

EXPERIMENTAL

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

Interventions

PXL Platinum 330 system DEVICE

to determine the efficacy of riboflavin solution and UV light to treat cornea thinning conditions

PXL 330

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy subjects with no other medical or ocular conditions
• 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:
• years of age or older
• Presence of central or inferior steepening (on Pentacam topograph)
• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration (See keratoconus grading section 7.0 for details)
• Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam such as:
• Fleischer ring
• Vogt's striae
• Decentered corneal apex
• Munson's sign
• Rizzutti's sign
• Apical Corneal scarring consistent with Bowman's breaks
• Scissoring of the retinoscopic reflex
• Crab-claw appearance on topography
• Steepest keratometry (Kmax) value ≥ 47.20 D on simK or Pentacam

You may not qualify if:

• active infections, collagen vascular disease, allergic to product
• All subjects meeting any of the following criteria will be excluded from this study:
• Eyes classified as either normal or atypical normal on the severity grading scheme.
• Corneal pachymetry at the screening exam that is \<300 microns at the thinnest point in the eye(s) to be treated.
• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
• History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
• Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
• Pregnancy (including plan to become pregnant) or lactation during the course of the study
• A known sensitivity to study medications
• Patients with cognitive or ambulatory conditions that would prevent eye drop compliance with medications
• Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
• Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.

Sponsors & Collaborators

• Cohen Laser and Vision Center: lead

Study Sites (1)

Cohen Laser and Vision Center

Boca Raton, Florida, 33431-1806, United States

RECRUITING

Related Publications (11)

• Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091.

  PMID: 16765803 RESULT

• Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.

  PMID: 20138607 RESULT

• Chatzis N, Hafezi F. Progression of keratoconus and efficacy of pediatric [corrected] corneal collagen cross-linking in children and adolescents. J Refract Surg. 2012 Nov;28(11):753-8. doi: 10.3928/1081597X-20121011-01.

  PMID: 23347367 RESULT

• El Rami H, Chelala E, Dirani A, Fadlallah A, Fakhoury H, Cherfan C, Cherfan G, Jarade E. An Update on the Safety and Efficacy of Corneal Collagen Cross-Linking in Pediatric Keratoconus. Biomed Res Int. 2015;2015:257927. doi: 10.1155/2015/257927. Epub 2015 Sep 29.

  PMID: 26491663 RESULT

• Hafezi F, Kanellopoulos J, Wiltfang R, Seiler T. Corneal collagen crosslinking with riboflavin and ultraviolet A to treat induced keratectasia after laser in situ keratomileusis. J Cataract Refract Surg. 2007 Dec;33(12):2035-40. doi: 10.1016/j.jcrs.2007.07.028.

  PMID: 18053900 RESULT

• Kumar Kodavoor S, Arsiwala AZ, Ramamurthy D. One-year clinical study on efficacy of corneal cross-linking in Indian children with progressive keratoconus. Cornea. 2014 Sep;33(9):919-22. doi: 10.1097/ICO.0000000000000197.

  PMID: 25055145 RESULT

• Mazzotta C, Balestrazzi A, Baiocchi S, Traversi C, Caporossi A. Stromal haze after combined riboflavin-UVA corneal collagen cross-linking in keratoconus: in vivo confocal microscopic evaluation. Clin Exp Ophthalmol. 2007 Aug;35(6):580-2. doi: 10.1111/j.1442-9071.2007.01536.x.

  PMID: 17760642 RESULT

• Moramarco A, Iovieno A, Sartori A, Fontana L. Corneal stromal demarcation line after accelerated crosslinking using continuous and pulsed light. J Cataract Refract Surg. 2015 Nov;41(11):2546-51. doi: 10.1016/j.jcrs.2015.04.033.

  PMID: 26703505 RESULT

• Raiskup F, Theuring A, Pillunat LE, Spoerl E. Corneal collagen crosslinking with riboflavin and ultraviolet-A light in progressive keratoconus: ten-year results. J Cataract Refract Surg. 2015 Jan;41(1):41-6. doi: 10.1016/j.jcrs.2014.09.033.

  PMID: 25532633 RESULT

• Vinciguerra P, Albe E, Frueh BE, Trazza S, Epstein D. Two-year corneal cross-linking results in patients younger than 18 years with documented progressive keratoconus. Am J Ophthalmol. 2012 Sep;154(3):520-6. doi: 10.1016/j.ajo.2012.03.020. Epub 2012 May 24.

  PMID: 22633357 RESULT

• Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.

  PMID: 12719068 RESULT

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Kelly Fitzgerald

  WCG IRB

  STUDY CHAIR

Central Study Contacts

GREGORY R Cohen, MD

CONTACT

5619818400; bocalasik@yahoo.com

Joshua D Cohen, MD

CONTACT

5619818400; joshua@cohenlaser.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Medical Director

Model Details: Single arm, non blinded study to determine the effectiveness of the PXL Platinum 330 system and Peschke TE (topical 0.25% riboflavin solution) for cornea thinning conditions (which is the "drug" or solution under investigation in combination with the specific UV light delivery system)

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 25, 2022
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2034
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)