Corneal blindness Eye Diseases
Conditions
Interventions
Based on the frequency of retroprosthetic inflammatory membranes formation after intraocular prosthesis implant (24.8% in an average follow-up period of 8.5 months), the sample size was estimated that
- the post-surgical visits will include: measurement of vital signs, ongoing topical and systemic therapies,
- efficacy assessment (vision measurement, questionnaire on daily activities), and safety a
Sponsors
Veneto Eye Bank Foundation
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old 2. Presence of light perception 3. Residual visual acuity limited to 1/10 (20/200) or worse 4. Clinical history of at least 2 keratoplasties of any type, performed for any indication and consecutively failed 5. Intraocular pressure = 22 mm Hg 6. Understanding of the clinical investigation scope and procedure and consent to participation.
Exclusion criteria
Exclusion criteria: 1. Clinical history of ocular and/or systemic diseases that could interfere with the effects of the study treatment or their evaluation (e.g., severe diseases of the ocular surface, severe diseases of the optical nerve, occlusion of the central retinal vein or artery, severe degenerative retinal alterations, retinal detachment, severe amblyopia, pthisis bulbi, etc.) 2. Any condition preventing the understanding or communication of informed consent, study requirements and test protocols, among which cognitive decline, including diagnosed forms of progressive neurological disease, psychiatric disease, deafness 3. Previous implant of other corneal prosthesis 4. Non acceptance of the study assessments and procedures 5. (For female subjects) pregnancy, breastfeeding or intention of planning a pregnancy in the study period 6. Ongoing participation, or participation in the 30 days before study enrolment, to any clinical study with investigational drug or medical device in the field of ophthalmology 7. Conditions that could limit the lifespan to less than 1 year from inclusion.
Countries
Italy
Contacts
Public ContactNadia Ambrosoli
Outcome results
None listed