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

• Sponsor: Eye Specialists of Indiana (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04213885
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 123.9
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus, Unstable; Ectasia Corneal; Bacterial Keratitis	Combination Product: PXL 330 Platinum device/Riboflavin	Phase 2

Detailed Description

Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure and visual function questionnaire.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Treatment of patients with diseaseTreatment of patients with disease
• Masking: Single (Outcomes Assessor)
• Masking Description: Randomized at outset
• Primary Purpose: Treatment
• Official Title: Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking With Corneal Thinning Conditions
• Actual Study Start Date: May 4, 2020
• Anticipated Primary Completion Date: Sep 1, 2029
• Anticipated Study Completion Date: Sep 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pulsed Accelerated 30mW, 5 sec, 5 sec off, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea	Combination Product: PXL 330 Platinum device/Riboflavin; 30mW, 5 sec, 5 sec off, 10 minutes of illumination
Active Comparator: Conventional 9mW continuous, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea	Combination Product: PXL 330 Platinum device/Riboflavin; 30mW, 5 sec, 5 sec off, 10 minutes of illumination

Outcome Measures

Primary Outcome Measures

1. Mean keratometry in diopters [1 year]

   Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer

Secondary Outcome Measures

1. Best corrected visual acuity [1 year]

   Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12. Criteria 13 is only relevant for contact lens wearers.

1. 12 years of age or older

2. Signed written informed consent

3. Willingness and ability to comply with schedule for follow-up visits

4. Presence of central or inferior steepening

5. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration

6. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as

7. Fleisher ring

8. Vogt's striae

9. Decentered corneal apex

10. Munson's sign

11. Rizzutti's sign

12. Apical corneal scarring consistent with Bowman's breaks

13. Scissoring of the retinoscopic reflex

14. Crab-claw appearance on topography

15. Steepest keratometry (Kmax) value greater than or equal to 47.2

16. I-S keratometry difference < 1.5 D on the Pentacam map or topography map

17. Posterior corneal elevation > 16 microns

18. Thinnest corneal point <485 microns

19. Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry

47.2, or patients undergoing PRK/SMILE in keratoconus suspect eyes

1. Bacterial or fungal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of >25% corneal thickness

2. Contact lens wearers only:

3. Removal of contact lenses for the require period of time prior to the screening refraction:

Contact Lens Type Discontinuations Time: Soft, 1 week; Soft Extended Wear, 2 weeks; Soft Toric, 3 weeks; Rigid Gas Permeable, 2 weeks per decade of wear -

Exclusion Criteria:

1. Eyes classified as normal or atypical normal on the severity grading scheme

2. Corneal pachymetry at the screening exam that is <300 microns at the the thinnest point in the eye(s) to be treated.

3. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

4. History of or active corneal disease (e.g. herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)

5. Clinically significant corneal scarring the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.

6. Pregnancy (including plan to become pregnant) or lactation during the course of the study

7. A known sensitivity to the study medications

8. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment of diagnostic tests.

9. Patients with a current condition that, in the physician's opinion, wold interfere with or prolong epithelial healing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Specialists of Indiana	Indianapolis	Indiana	United States	46220

Sponsors and Collaborators

• Eye Specialists of Indiana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eye Specialists of Indiana
• ClinicalTrials.gov Identifier: NCT04213885
• Other Study ID Numbers: PXL330-001
• First Posted: Dec 30, 2019
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Keratoconus; Keratitis; Riboflavin

Study Results

No Results Posted as of Aug 17, 2021