Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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

Первичные конечные точки

• Mean keratometry in diopters [Срок оценки: 12 months]

Вторичные конечные точки (1)

• Best corrected visual acuity [Срок оценки: 12 months]

Критерии участия

Критерии включения

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.

• 12 years of age or older
• Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)
• Presence of central or inferior steepening.
• Axial topography consistent with keratoconus
• Presence of one or more findings associated with keratoconus 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
• I-S keratometry difference > 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
• Posterior corneal elevation >16 microns
• Thinnest corneal point <485 microns
• AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits
• For Contact Lens Wearers Only: 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: 2 Weeks per decade of wear
• Scleral Lenses
• Investigator Discretion \[Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening\]
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits

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

• Eyes classified as either normal or atypical normal on the severity grading scheme.
• Corneal pachymetry at the screening exam that is <330 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 nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
• Patients with active medical implants (e.g. cardiac pacemakers)'
• Patients who are aphakic/ pseudophakic

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Pacific Clear Vision Institute — Eugene

Публикации

• 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
• 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
• 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
• 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. PMID 25060847

Идентификаторы

NCT: NCT03918408 · 1005312

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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