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CTRI Number  CTRI/2024/09/074516 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Research study to evaluate the benefit, safety and effectiveness of an eye implant to rectify blindness. 
Scientific Title of Study   A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
DMS-41100, Version B-2, Date 14-02-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Virender Singh Sangwan 
Designation  Director, Innovation  
Affiliation  Dr Shroffs Charity Eye Hospital 
Address  Vitreoretina Department First Floor Room No. 1 Dr Shroffs Charity Eye Hospital 5027 Kedar Nath Road Daryaganj New Delhi

New Delhi
DELHI
110002
India 
Phone  9849294656  
Fax    
Email  virender.sangwan@sceh.net  
 
Details of Contact Person
Scientific Query  
Name  Mala Srivastava 
Designation  Co-founder & Managing Partner 
Affiliation  Nextvel Consulting LLP 
Address  Nextvel Consulting LLP Novel Business Park, # 57, Salarpuria Triton, 13th Cross, Anepalya Bangalore KARNATAKA 560030 India

Bangalore
KARNATAKA
560030
India 
Phone  9845238384  
Fax    
Email  malas@nextvel.com  
 
Details of Contact Person
Public Query  
Name  Mala Srivastava 
Designation  Co-founder & Managing Partner 
Affiliation  Nextvel Consulting LLP 
Address  Nextvel Consulting LLP Novel Business Park, # 57, Salarpuria Triton, 13th Cross, Anepalya Bangalore KARNATAKA 560030 India

Bangalore
KARNATAKA
560030
India 
Phone  9845238384  
Fax    
Email  malas@nextvel.com  
 
Source of Monetary or Material Support  
Nextvel Consulting LLP Novel Business Park No 57, Salarpuria Triton, 13th Cross Anepalya Bengaluru Bengaluru (Bangalore) Urban Karnataka - 560030 
 
Primary Sponsor  
Name  CorNeat Vision Ltd 
Address  4 Hasheizaf St. Raanana, Israel 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Canada
France
Israel
Netherlands
Peru
India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namrata Sharma  All India Institute of Medical Sciences  4th Floor Room No 494, 495 Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi-110048
New Delhi
DELHI 		 9810856988

namrata.sharma@gmail.com 
Dr Virender Singh Sangwan  Dr Shroffs Charity Eye Hospital  Vitreoretina Department First Floor Room No. 1 Dr Shroffs Charity Eye Hospital 5027 Kedar Nath Road Daryaganj New Delhi
New Delhi
DELHI 		 9849294656

virender.sangwan@sceh.net 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Ethics Committee  Approved 
Dr Shroffs Charity Eye Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H540||Blindness, both eyes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CorNeat KPro  The CorNeat KPro is a patented synthetic corneal implant (keratoprosthesis) developed to provide a long-lasting medical solution for corneal blindness, pathology, and injury. The investigational device will be unilaterally implanted where the optical component of the CorNeat KPro will be implanted into a circular disc of the cornea (as performed in standard penetrating keratoplasty surgery) and the skirt component will be embedded under a 360º conjunctival flap. The implantation is done once. The CorNeat KPro is designed to provide an accessible, efficient, effective, and reliable remedy for people with cornea-related visual impairments. The CorNeat KPro utilizes a novel polymeric bio-integrating skirt to assimilate synthetic optics within resident ocular tissue. Other currently available solutions rely either on donor tissue (keratoplasty), or synthetic implants mounted on biological carrier tissues and then attached to the native corneal tissue – a tissue lacking blood vessels and healing capacity. In contrast, the CorNeat KPro integrates seamlessly with the eyewall, underneath the conjunctiva, and over the sclera where scarring potential is maximal. The CorNeat KPro Implantation Kit (“the device”) comprises the CorNeat KPro and a toolset.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Male or female aged ≥ 21 and ≤ 80 years on the day of screening
2. Candidates must have the ability and willingness to attend all scheduled visits and
comply with all study procedures
3. Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In case of
unilateral blindness – BCVA of Counting Fingers (CF) from 1 meter or worse in the
operated eye
4. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable
option or following a verifiable history of prior failed corneal transplantation
5. Indications that fall under poor candidate for keratoplasty include but are not limited
to scarred cornea following transplantation failure, which can be either vascularized,
limbal stem cell-deficient and/or following burn/trauma
6. Adequate tear film and lid function
7. Perception of light in all quadrants
8. Female patients of childbearing age must have a negative pregnancy test at screening
and agree to use an effective method of contraception throughout the study 
 
ExclusionCriteria 
Details  1. Reasonable chance of success with traditional keratoplasty
2. Current retinal detachment
3. Connective tissue diseases or severely scarred conjunctiva in the target eye
4. End-stage glaucoma or evidence of current uncontrolled glaucoma
5. History or evidence of severe inflammatory eye diseases (i.e., conjunctivitis, uveitis,
retinitis, scleritis)
6. Active inflammation of the conjunctiva in one or both eyes
7. History of ocular or periocular malignancy
8. History of extensive keloid formation
9. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or
components of the device
10. Ocular ischemic syndrome 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The anatomical retention rate will be calculated and presented as the number of
patients with retained device out of the total number of patients at the respective
follow up visit. To clarify, anatomical retention refers to whether the device remains in
place and intact within the eye. This will be evaluated by the presence or absence of
complications such as device extrusion, endophthalmitis, or glaucoma. 		 Throughout 24 months post-op 
 
Secondary Outcome  
Outcome  TimePoints 
Best Corrected Distant Visual Acuity will be determined using ETDRS visual acuity chart,
where applicable, at each of the follow up visits throughout the trial’s duration and will
be compared to that measured before KPro’s implantation.
Additionally, if applicable, mean BCVA at each time point and the percentage of eyes
with ≥6/120 vision will be calculated. 		 Throughout 24 months post-op 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/03/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The CorNeat KPro is a patented synthetic corneal implant (keratoprosthesis) developed to provide a long-lasting medical solution for corneal blindness, pathology, and injury. The CorNeat KPro is designed to provide an accessible, efficient, effective, and reliable remedy for people with cornea-related visual impairments. The CorNeat KPro utilizes a novel polymeric bio-integrating skirt to assimilate synthetic optics within resident ocular tissue. Other currently available solutions rely either on donor tissue (keratoplasty), or synthetic implants mounted on biological carrier tissues and then attached to the native corneal tissue – a tissue lacking blood vessels and healing capacity. In contrast, the CorNeat KPro integrates seamlessly with the eyewall, underneath the conjunctiva, and over the sclera where scarring potential is maximal. The CorNeat KPro Implantation Kit (“the device”) comprises the CorNeat KPro and a toolset.
This product is under clinical investigation worldwide and is risk classified as, Class C (Sterile). As per Indian Regulations, also it falls under the High-Risk classification of Class C since it is a permanent ocular implant
 
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