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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
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.
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.
L V Prasad Eye Institute, Centre for Ocular Regeneration
Hyderabad, India
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.
Time frame: 12 months
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)
Time frame: 12 months
Visual acuity measured by LogMAR
Time frame: 12 months
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