Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea in Patients Requiring Anterior Lamellar Keratoplasty

Study Overview
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Brief Summary
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In this study safety and effectiveness of bioengineered cornea comprising of interpenetrating networks of recombinant human type III collagen and synthetic phospholipid - phosphorylcholine - will be tested in patients with corneal scars (leukomas) after infection, trauma or keratoconus. Control group will consist of patients with the same condition who will undergo corneal transplantation - current standard of care.

Detailed Description
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Recently developed and passed extensive pre-clinical testing collagen-phosphorylcholine(RHCIII-MPC) corneal substitute will be implanted in patient's corneas with corneal scar (leukoma) developed after infection, trauma or keratoconus using anterior lamellar keratoplasty technique, i.e. once patient's diseased anterior part of cornea is removed, either manually or with assistance of femtosecond laser, it will be substituted with proposed transparent implant. Control patients with same condition will be grafted with human donor cornea using the same surgical technique. The investigators will test the safety and the effectiveness of developed biosynthetic corneas. Overall 20 patients are planned to recruit. They will be randomized in two groups - 10 patients will undergo RHCIII-MPC cornea implantation, another 10 will be impanted with human donor cornea. The patients will be follow-uped for 12 months.

Official Title
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A Prospective, Randomized, Open Label Clinical Trial to Evaluate the Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea Compared to Human Cornea in Patients Requiring Anterior Lamellar Keratoplasty

Conditions
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Leukoma

Intervention / Treatment
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* Device: RHCIII-MPC cornea
* Device: Donor cornea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must sign and be given a copy of the written Informed Consent form. Subjects with best corrected distance visual acuity +1.0 LogMAR or worse as a result of corneal scar due to infection, injury or keratoconus in the operative eye. Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery. Exclusion Criteria: Subjects with severe or life-threatening systemic disease. Subjects with uncontrolled hypertension. Subjects with uncontrolled diabetes or insulin-dependent diabetes. Subjects with glaucoma in either eye. Subjects with marked microphthalmos or aniridia in either eye. Subjects with any other serious ocular pathology, serious ocular complications at the time of surgery underlying serious medical conditions, based on the investigator's medical judgment. Subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RHCIII-MPC Biosynthetic Cornea
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RHCIII-MPC cornea<br>Patients of this arm will undergo RHCIII-MPC bioengineered cornea transplantation using anterior lamellar keratoplasty technique | Device: RHCIII-MPC cornea<br>* Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to 350 um of corneal thickness and then a lamellar dissection will be created. Trephine diameter will be 7.5 mm. Alternatively a femtosecond laser may be used to create the dissection. A RHCIII-MPC cornea 350 um thick and equal or 0.25 mm larger diameter is placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens will be removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.<br>|
| Active Comparator: Donor cornea<br>Patients of this arm will undergo human donor cornea transplantation using anterior lamellar keratoplasty technique | Device: Donor cornea<br>* Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to 350 um of corneal thickness and then a lamellar dissection will be created. Trephine diameter will be 7.5 mm. Alternatively a femtosecond laser may be used to create the dissection. A human donor cornea graft 350 um thick and 0.25 mm larger diameter is placed and sutured. The sutures will be removed in 3-6 months or as determined by physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Degree of eye inflammation) | Degree of eye inflammation based on conjunctival injection, perifocal corneal haze, aqueous humor transparency, increased intraocular pressure and self reported postoperative pain. Each item is scored 0-4: 0 = no symptom, 4 = severe symptom. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biocompatability, degree of haze and/or vascularisation measured on a scale 0-4 | The implant/donor cornea graft biocompatability will be checked by degree of haze and/or vascularisation measured on a scale 0-4 (0 - transparent implant/graft, no vessels, 4 - haze does not allow visualizing pupil, vessels enter entire surface of implant/graft) | 12 months | 
| Visual acuity measured by LogMAR |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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keratoplasty, bioengineered cornea, donor cornea