CTRI Number	CTRI/2014/10/005114 [Registered on: 16/10/2014] Trial Registered Retrospectively
Last Modified On:	25/06/2018
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Medical Device
Study Design	Single Arm Trial
Public Title of Study Modification(s)	A study to compare the efficacy of artificial cornea in restoring vision in comparison to human cornea transplant.
Scientific Title of Study Modification(s)	A Clinical Trial to evaluate the safety and effectiveness of the RHCIII-MPC biosynthetic cornea in patients requiring deep anterior lamerllar keratoplasty
Secondary IDs if Any	Secondary ID  Registry  LVPEI-RHCIII-MPCBIOSYNTHETIC CORNEA  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Virender S Sangwan  Address  L V Prasad Eye Institute Kallam Anji Reddy Campus L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034 L V Prasad Eye Institute Kallam Anji Reddy Campus L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034 Hyderabad ANDHRA PRADESH 500034 India  Phone  040-30612632   Fax  040-23548271   Email  vsangwan@lvpei.org
Details Contact Person Scientific Query	Name  Dr Virender S Sangwan  Address  L V Prasad Eye Institute Kallam Anji Reddy Campus L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034 L V Prasad Eye Institute Kallam Anji Reddy Campus L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034 Hyderabad ANDHRA PRADESH 500034 India  Phone  040-30612632   Fax  040-23548271   Email  vsangwan@lvpei.org
Details Contact Person Public Query	Name  Dr Virender S Sangwan  Address  L V Prasad Eye Institute Kallam Anji Reddy Campus L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034 L V Prasad Eye Institute Kallam Anji Reddy Campus L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034 Hyderabad ANDHRA PRADESH 500034 India  Phone  040-30612632   Fax  040-23548271   Email  vsangwan@lvpei.org
Source of Monetary or Material Support	Linkoping University Department of Clinical and Experimental Medicine Division of Cell Biology S-581 85 Linköping Sweden
Primary Sponsor	Name  Dr May Griffith  Address  Linkoping University Department of Clinical and Experimental Medicine Division of Cell Biology S-581 85 Linköping Sweden   Type of Sponsor  Other [Academic, no commercial support]
Details of Secondary Sponsor	Name  Address  Dr Virender S Sangwan  L V Prasad Eye Institute Kallam Anji Reddy Campus L.V.Prasad Marg, Banjara Hills, Hyderabad - 500 034
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Virender S Sangwan  L V Prasad Eye Institute  Dr.Virender S Sangwan, Director, Center for Ocular Regeneration (CORE) Director, Srujana-Center for Innovation Dr. Paul Dubord Chair in Cornea, Room D, Sixth Floor L V Prasad Eye Institute, Kallam Anji Reddy Campus L.V.Prasad Marg, Banjara Hills, Hyderabad-500 034 Hyderabad   040-30612632 040-23548271 vsangwan@lvpei.org
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Hyderabad Eye Research Foundation  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Corneal Scar
Intervention / Comparator Agent	Type  Name  Details  Intervention  Biosynthetic RHC III Biosynthetic Cornea  Anterior lamellar Keratoplasty  Comparator Agent  Human donar Cornea  Anterior lamellar Keratoplasty
Inclusion Criteria	Age From  18.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  1. Subjects must sign and be given a copy of the written Informed Consent form. 2. Subjects with CDVA 20/200 or worse as a result of corneal scar due to injury or infection in the operative eye or from progressive keratoconus or Dystrophies or any other causes requiring DALK. 3. Subjects must be≥18 and ≤ 60 years of age at the time of subject eligibility visit. 4. Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.
ExclusionCriteria	Details  1.Subjects with severe or life-threatening systemic disease. 2.Subjects with uncontrolled hypertension. 3. Subjects with autoimmune disease. 4. Subjects with uncontrolled diabetes or insulin-dependent diabetes. 5. Subjects with an ocular infection. 6. Subjects with any anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis, iritis, corneal dystrophy, pseudoexfoliation, etc. in the operative eye. 7. Subjects with glaucoma in either eye. 8.Subjects with previous retinal detachment or retinal pathology in the operative eye. 9.Subjects with congenital bilateral cataracts. 10.Subjects with marked microphthalmos or aniridia in either eye. 11.Subjects who have had previous ocular surgery in the operative eye, except pterygium or strabismus surgeries which may be allowed based on clinical evaluation. 12.Subjects who are or lactating or who plan to become pregnant over the course of the clinical investigation. 13.Subjects with any other serious ocular pathology,serious ocular complications at the time of corneal transplant underlying serious medical conditions,based on the Investigator medical judgement.
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Visual Acuity Clarity of Implant   Preoperative Evaluation (Day -60 to Day -1) Operative Evaluation (Day 0) Day 1(24 to 36 hours post-op) Week 1 (5 to 9 days post-op) Month 1(3 to 5 weeks post-op) Month 6(21 to 26 weeks post-op) Month 9 Month 12
Secondary Outcome	Outcome  TimePoints  1. Manifest refraction Preoperative 2. Uncorrected visual acuity (ETDRS) 3. Distance-corrected visual acuity without add (ETDRS) 4. Distance-corrected near visual acuity with add (ETDRS) 5. Slit lamp examination 6. Central keratometry 7. Computerized corneal topography 8. Specular microscopy of the corneal endothelium on both eyes 9. Central applanation intraocular pressure 10. Dilated fundus examination 11. Anterior segment OCT 12. Subject questionnaire   Preoperative Evaluation (Day -60 to Day -1) Operative Evaluation (Day 0) Day 1 (24 to 36 hours post-op) Week 1(5 to 9 days post-op) Month 1 (3 to 5 weeks post-op) Month 6 (21 to 26 weeks post-op) Month 9 Month 12
Target Sample Size	Total Sample Size="10" Sample Size from India="10"
Phase of Trial	Phase 1/ Phase 2
Date of First Enrollment (India)	05/09/2014
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="5" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Suspended
Publication Details Modification(s)	NONE YET
Brief Summary	There is a pronounced deficiency in the world of donor corneas for transplantation. In Western countries the lack of donor corneas is relative but in developing countries there is almost a total absence of availability of donor corneas. Diseases such as trachoma, vitamin A deficiency (xerophthalmia), measles, and bacterial infections are among the leading causes of blindness that can be addressed with corneal transplantation.The choice of material during the 12 years of development has gone from animal collagen to human recombinant collagen, cross-linked with a synthetic molecule composed of recombinant human collagen type III (RHCIII) produced by Fibrogen Inc., USA, by genetic engineering, in yeast. The resulting processed and purified collagen is cross-linked to a carbodiimide, a chemical belonging to the family of water soluble crosslinking agents for fabrication into a hydrated implant or hydro gel. The material has undergone a series of tests with regard to toxicity prior to clinical testing. Nerve regeneration function was demonstrated using in vivo confocal microscopy. The advantage of repopulation of by host keratocytes will improve corneal transparency as the bioengineered cornea will be act more like a “normal” cornea. The implants have been reinforced with a network of phosphorylcholine making them stronger but allowing them to retain all the cell friendly properties and promote regeneration in a range of animal models including mice, guinea pigs, rabbits and mini-pigs. The matrices have been transplanted with a deep lamellar technique during experimentation.The study planned under this protocol will use a reinforced, improved version of the material.