- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02424006
Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea in Patients Requiring Anterior Lamellar Keratoplasty
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hyderabad, India, 500034
- L V Prasad Eye Institute, Centre for Ocular Regeneration
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RHCIII-MPC cornea
Patients of this arm will undergo RHCIII-MPC bioengineered cornea transplantation using anterior lamellar keratoplasty technique
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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.
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Active Comparator: Donor cornea
Patients of this arm will undergo human donor cornea transplantation using anterior lamellar keratoplasty technique
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (Degree of eye inflammation)
Time Frame: 12 months
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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.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biocompatability, degree of haze and/or vascularisation measured on a scale 0-4
Time Frame: 12 months
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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)
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12 months
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Visual acuity measured by LogMAR
Time Frame: 12 months
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Virender S Sangwan, MBBS, MS, LV Prasad Eye Institute
Publications and helpful links
General Publications
- Liu W, Deng C, McLaughlin CR, Fagerholm P, Lagali NS, Heyne B, Scaiano JC, Watsky MA, Kato Y, Munger R, Shinozaki N, Li F, Griffith M. Collagen-phosphorylcholine interpenetrating network hydrogels as corneal substitutes. Biomaterials. 2009 Mar;30(8):1551-9. doi: 10.1016/j.biomaterials.2008.11.022. Epub 2008 Dec 20.
- Fagerholm P, Lagali NS, Ong JA, Merrett K, Jackson WB, Polarek JW, Suuronen EJ, Liu Y, Brunette I, Griffith M. Stable corneal regeneration four years after implantation of a cell-free recombinant human collagen scaffold. Biomaterials. 2014 Mar;35(8):2420-7. doi: 10.1016/j.biomaterials.2013.11.079. Epub 2013 Dec 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201503-001
- LVPEI-RHCIII-MPC CORNEA (Other Identifier: Clinical Trial Registry - India)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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