Corneal Blindess, Corneal Inflammation, Deep Anterior Lamellar Keratoplasty, High-risk Corneal Transplantation
Conditions
Keywords
cornea, biosynthetic implants, tissue regeneration
Brief summary
This is an open-label and prospective clinical trial, in which a maximum of 5 eyes of 5 patients will receive a CLP-PEG-MPC synthetic cornea during deep anterior lamellar keratoplasty (DALK) surgery and will be followed up over 24 months.
Detailed description
This is a prospective open-label clinical trial of patients who will receive a CLP-PEG-MPC synthetic cornea during deep anterior lamellar keratoplasty (DALK) corneal transplantation surgery and be followed over 24 months. The primary objective is to demonstrate the safety and tolerability of CLP-PEG-MPC biosynthetic corneal implants. The secondary objective is to examine the preliminary efficacy of these implants to stimulate corneal tissue regeneration, provide optical clarity and improvement of vision. Randomization is not appropriate in a first-in-human pilot study. Blinding is not possible as surgeons can easily tell a cell-free implant apart from a donor allograft.
Interventions
DEVICECLP-PEG-MPC
Implantation of a 500 um thick biosynthetic corneal implant utilizing DALK surgical technique
PROCEDUREHuman donor cornea penetrating keratoplasty
Implantation of a human donor cornea graft utilizing PKP surgical technique
Sponsors
Maisonneuve-Rosemont Hospital
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Once qualified, subjects will be enrolled to receive a CLP-PEG-MPC implant by DALK. DALK surgery requires the precise dissection of the central 8 mm of the corneal stroma from the underlying posterior corneal layers (Dua layer, Descemet membrane and endothelium, approximately 30 microns thick). The dissection performed during DALK may perforate the posterior corneal layers, requiring conversion to full-thickness penetrating keratoplasty (PKP). Subjects who require conversion to PKP will receive a full-thickness human donor cornea as a safety measure and will be followed per protocol as a comparison group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. adult age (18 years or older at the time of subject eligibility visit) 2. able to provide signed, informed consent 3. unilateral corneal opacity not involving the posterior corneal layers (Descemet membrane and endothelium) for which DALK is indicated 4. visual acuity less than 20/200 in the affected eye and better than 20/50 in the contralateral eye (i.e. monocular blindness) 5. presence of at least one of the following high-risk criteria for corneal transplantation using a human cornea donor graft: 5i) inflammation 5ii) active infection 5iii) stromal neovascularization 5iv) neurotrophism 5v) autoimmune disease 5vi) previous DALK graft failure 6. availability for 24 months of postoperative follow-up
Exclusion criteria
1. Age under 18 years 2. Inability to give informed consent 3. Previous corneal perforation precluding DALK surgery 4. Endothelial pathology requiring penetrating keratoplasty 5. Limbal stem cell deficiency affection more than 50% of the limbus 6. Previous penetrating or endothelial keratoplasty 7. Bilateral blindness 8. Nystagmus 9. Uncontrolled glaucoma or intraocular pressure 10. Documented macular disease (age-relate macular degeneration, macula-involving retinal detachment, macular hole) 11. Documented amblyopia of surgical eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual acuity - best-spectacle correction | 24 months | best-spectacle corrected visual acuity |
| conjunctival inflammation | 24 months | bulbar conjunctival inflammation (scale 0-none to 4-worse) |
| intraocular inflammation | 24 months | anterior uveitis (SUN classification of cell and flare for anterior uveitis) |
| complications | 24 months | occurence of implant-related complications |
| visual acuity - uncorrected | 24 months | uncorrected visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| corneal thickness | 24 months | central corneal pachymetry |
| corneal sensation | 24 months | Central corneal esthesiometry using Cochet-Bonnet esthesiometer |
| Refraction | 24 months | eye refractive error |
| ocular pain | 24 months | intensity of ocular pain and discomfort (questions 1,3, 10, 11 and 12 from Ocular Surface Disease Index questionnaire) |
Outcome results
None listed