CTRI Number	CTRI/2021/04/033197 [Registered on: 28/04/2021] Trial Registered Prospectively
Last Modified On:	18/10/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Medical Device
Study Design	Single Arm Study
Public Title of Study	Study to see the Safety and Effectiveness of a custom made Porcine lens named as XeniaTM after implanting in patients having Keratoconus meaning Thin and Irregular cornea
Scientific Title of Study	Prospective Investigators Initiated Study to Evaluate the Safety and Indicative Effectiveness of XeniaTM custom made ocular implant in subjects having Keratoconus
Secondary IDs if Any	Secondary ID  Registry  HERF-XENIA-IIS-01 Version 3.0 Dated October19, 2020  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Pravin Krishna V  Address  L V Prasad Eye Institute,Room N: 123,clinical research department,1st floor GPR building, L V Prasad Marg Road No. 2, Banjara Hills Hyderabad 500034, Telangana India Hyderabad TELANGANA 500034 India  Phone  9849094245   Fax     Email  pravin@lvpei.org
Details Contact Person Scientific Query Modification(s)	Name  Dr Pravin Krishna V  Address  L V Prasad Eye Institute,Room No:123,clinical research department,1 st floor,GPR building, L V Prasad Marg Road No. 2, Banjara Hills Hyderabad 500034, Telangana India Hyderabad TELANGANA 500034 India  Phone  9849094245   Fax     Email  pravin@lvpei.org
Details Contact Person Public Query Modification(s)	Name  Dr Pravin Krishna V  Address  L V Prasad Eye Institute, Room No: 123, Clinical research department, 1 st floor,GPR building, L V Prasad Marg Road No. 2, Banjara Hills Hyderabad 500034, Telangana India Hyderabad TELANGANA 500034 India  Phone  9849094245   Fax     Email  pravin@lvpei.org
Source of Monetary or Material Support Modification(s)	Gebauer Medizintechnik GmbH.
Primary Sponsor Modification(s)	Name  Mr Steffen Gebauer  Address  GEBAUER MEDIZINTECHNIK GmbH Monbachstrasse 7/1 75242 Neuhausen, Germany  Type of Sponsor  Other [Medical Technology Manufacturer]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Pravin Krishna V  L V Prasad Eye Institute  LV Prasad Eye Institute,Room no: 123,1st floor GPR building,clinical research department, LV Prasad Marg, Banjara Hills, Road No.2, Hyderabad 500034, Telangana Hyderabad   9849094245 pravin@lvpei.org
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  L V Prasad Eye Institute Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Approved/Obtained
Health Condition / Problems Studied	Health Type  Condition  Patients  Keratoconus
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Comparator Agent  Not Applicable  Not Applicable  Intervention  XENIA  XENIA is a corneal implant made of natural corneal collagen of animal (porcine) origin, in stabilizing the keratoconic cornea. XENIA material, natural corneal collagen, has been successfully validated by Mother Nature- with a follow- up of more than 450 million years with excellent results. The XENIA material is completely devoid of foreign cells and, hence much more tolerable. Xenia is reversible and DALK (Deep Anterior Lamellar Keratoplasty) can still be performed in a worst- case situation. XENIA is in full compliance with the latest EU Medical Device Regulation (MDR) 2017/745.
Inclusion Criteria	Age From  18.00 Year(s) Age To  40.00 Year(s) Gender  Both  Details  1. Diagnosis of keratoconus 2. Visual Acuity with contact lenses must be better than or equal to 20/40 3. Patients must be intolerant of contact lenses, i.e., they must be unable to wear contact lenses for a whole day 4. Patients will have a minimal corneal thickness of 350 microns 5. In terms of general health, patients must not have any illnesses posing an immediate threat to life 6. Patients must over 18 years of age 7. Patients contact lenses must have been removed at least one week prior to surgery for spft contact lenses and two weeks prior to surgery for hard lenses 8. Must be able to complete all study visits 9. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study specific tests or procedures are performed
ExclusionCriteria	Details  1. Prior corneal surgery in the keratoconus group 2. Corneal scarring 3. History of other ocular pathologies that will interfere with the treatment 4. Active infection of the cornea 5. Subject with history of neurotrophic cornea 6. Subject with history of persistent corneal erosion difficulties with epithelial growth i.e., re epithelization 7. Pregnancy and lactation 8. History of previous ophthalmologic surgery on the operative eye 9. Patients refusing to remove contact lenses one week before surgery for soft lenses and two weeks before surgery for hard lenses 10. Patients with amblyopia, VA less than 20/200 for the contralateral eye 11. Patients with corneal thickness of less than 350 microns 12. Patients with IOP of less than 10 mmHg or than than 21 mmHg 13. Patients with an uncooperative disposition 14. Subject who is currently participating or have participated in an investigational study, other than the study, within the past 60 days
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome	Outcome  TimePoints  The frequency and severity of all treatment- related adverse events, during and after implantation of the XeniaTM and throughout the 6 month follow-up period. Adverse events will be assessed on a continuous basis from the procedure through the study completion at 6 months. Related adverse events include: corneal perforation, melting, uncontrolled inflammation, severe infection.  Day 1, 3, 7, 14 Week 4, 8, 10, 12 Month 4, 5, 6, 8, 10, 12
Secondary Outcome	Outcome  TimePoints  1. Change in Keratometry [Time Frame: 3 months] 2. Subjective corneal clarity 3. Measurement of Best Corrected Distance Visual Acuity (BCDVA)  Time Frame: 3 months (Change in Keratometry)
Target Sample Size	Total Sample Size="5" Sample Size from India="5"
Phase of Trial	N/A
Date of First Enrollment (India)	03/05/2021
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="1" Days="1"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Closed to Recruitment of Participants
Publication Details	Not applicable as of now
Brief Summary	This is a Prospective open-label, academic investigator initiated clinical study. The primary aim of this study is to assess the safety of implanting the Xenia TM in subjects suffering from Keratoconus. Safety will be assessed by evaluating the rate of adverse events and adverse device effects occurred throughout the study period. Efficacy will be assessed by measuring the change in best corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity, changes in corneal thickness, corneal clarity and ocular refraction. The double rationale of using Xenia TM is 1. thicken the pathological cornea using material which is almost identical in structure andcomposition to the corneal stroma improving the BCVA 2. support to the cornea as a whole preventing the progression of the keratoconus disease.