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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.

 

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