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

NCT ID: NCT04213885

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2024-08-05

Brief Summary

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

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.

Conditions

Keratoconus, Unstable; Ectasia Corneal; Bacterial Keratitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

PXL 330 Platinum device/Riboflavin

Intervention Type: COMBINATION_PRODUCT

30mW, 5 sec, 5 sec off, 10 minutes of illumination

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

Group Type: ACTIVE_COMPARATOR

PXL 330 Platinum device/Riboflavin

Intervention Type: COMBINATION_PRODUCT

30mW, 5 sec, 5 sec off, 10 minutes of illumination

Interventions

PXL 330 Platinum device/Riboflavin

30mW, 5 sec, 5 sec off, 10 minutes of illumination

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

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

1. Fleisher ring

2. Vogt's striae

3. Decentered corneal apex

4. Munson's sign

5. Rizzutti's sign

6. Apical corneal scarring consistent with Bowman's breaks

7. Scissoring of the retinoscopic reflex

8. Crab-claw appearance on topography

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

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

9. Posterior corneal elevation > 16 microns

10. Thinnest corneal point <485 microns

11. Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2, or patients undergoing PRK/SMILE in keratoconus suspect eyes

12. 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

13. Contact lens wearers only:

1. 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:

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

2. 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.

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

5. A known sensitivity to the study medications

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

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

-

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eye Specialists of Indiana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eye Specialists of Indiana

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

PXL330-001

Identifier Type: -

Identifier Source: org_study_id