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

Bacterial Keratitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03918408
• Other study ID #: 1005312
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2019
• Est. completion date: June 2030

Study information

• Verified date: December 2022
• Source: Pacific Clear Vision Institute
• Contact: BALAMURALI AMBATI, MD, PhD
• Phone: 541-343-5000
• Email: bambati[@]pcvi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2030
• Est. primary completion date: June 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 45 Years

Eligibility

Inclusion Criteria:

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:

1. 12 years of age or older

2. Presence of central or inferior steepening.

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

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

1. Fleischer 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

5. Steepest keratometry (Kmax) value = 47.20 D

6. I-S keratometry difference > 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map

7. Posterior corneal elevation >16 microns

8. Thinnest corneal point <485 microns

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

10. AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).

11. Bacterial or fungal corneal 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

12. Contact Lens Wearers Only:

a. Removal of contact lenses for the required period of time prior to the screening refraction:

Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid gas permeable Scleral Lenses 2 Weeks per decade of wear Investigator Discretion

Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening.

13. Signed written informed consent

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

Exclusion Criteria (any of the following are reasons for exclusion):

1. All subjects meeting any of the following criteria will be excluded from this study:

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

2. Corneal pachymetry at the screening exam that is <300 microns at 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, acanthomeoeba, etc.)

2. 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.

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

5. A known sensitivity to study medications

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

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

Related Conditions & MeSH terms

• Bacterial Keratitis
• Ectasia of Cornea
• Keratitis
• Keratoconus
• Keratoconus, Unstable

Intervention

Combination Product:
• PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Locations

Country	Name	City	State
United States	Pacific Clear Vision Institute	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Pacific Clear Vision Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean keratometry in diopters	Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer	1 year
Secondary	Best corrected visual acuity	Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale	1 year