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
|
|
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. |