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To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed, accelerated | Experimental | 18 mW, 5 sec, 5 sec off, 10 minutes of illumination |
|
| Conventional | Active Comparator | 9 mW, continuous 10 minutes of illumination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution | Combination Product | Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea |
| Measure | Description | Time Frame |
|---|---|---|
| Mean keratometry in diopters | Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale | 12 months |
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Inclusion Criteria:
Subjects who have one or both eyes that meet criteria 1 & 2 and 1 or more of the following criteria will be considered candidates for this study.
Exclusion Criteria (any of the following are reasons for exclusion):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BALAMURALI AMBATI, MD, PhD | Contact | 541-343-5000 | bambati@pcvi.com |
| Name | Affiliation | Role |
|---|---|---|
| BALAMURALI AMBATI, MD, PhD | PCVI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Clear Vision Institute | Recruiting | Eugene | Oregon | 97401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16765803 | Background | 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. | |
| 20138607 | Background |
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Individual participant data will be stored in a secure location. While summary outcomes data will be provided on request to other researchers and periodically at scientific conferences, protected health information will not.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2019 | Jun 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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Treatment of patients with disease
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Randomized at outset
|
| 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. |
| 23347367 | Background | 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. |
| 25060847 | Background | Mazzotta C, Traversi C, Caragiuli S, Rechichi M. Pulsed vs continuous light accelerated corneal collagen crosslinking: in vivo qualitative investigation by confocal microscopy and corneal OCT. Eye (Lond). 2014 Oct;28(10):1179-83. doi: 10.1038/eye.2014.163. Epub 2014 Jul 25. |