| CTRI Number |
CTRI/2025/06/088660 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Study to see the Performance of Custom-Made Porcine lens named as XENIA™ Corneal Implant to improve near vision in patients having presbyopia (age-related farsightedness). |
|
Scientific Title of Study
|
Prospective Post-Marketing Clinical Follow-Up (PMCF) Study to Evaluate the Performance of Custom-Made XENIA™ Corneal Implants for The Treatment of Presbyopia
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HERF-XENIA-P-01 Version 1.0 Dated January 31, 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravin Krishna V |
| Designation |
Ophthalmologist |
| Affiliation |
Hyderabad Eye Research Foundation, L V Prasad Eye Institute |
| Address |
Department of Ophthalmology, L V Prasad Eye Institute, 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 of Contact Person
Scientific Query
|
| Name |
Dr Pravin Krishna V |
| Designation |
Ophthalmologist |
| Affiliation |
Hyderabad Eye Research Foundation, L V Prasad Eye Institute |
| Address |
Department of Ophthalmology, L V Prasad Eye Institute, L V Prasad Marg Road No. 2, Banjara Hills
Hyderabad, - 500034 Telangana, India
TELANGANA
500034
India |
| Phone |
9849094245 |
| Fax |
|
| Email |
pravin@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravin Krishna V |
| Designation |
Ophthalmologist |
| Affiliation |
Hyderabad Eye Research Foundation, L V Prasad Eye Institute |
| Address |
Department of Ophthalmology, V Prasad Eye Institute, L V Prasad Marg Road No. 2, Banjara Hills
Hyderabad, - 500034 Telangana, India
TELANGANA
500034
India |
| Phone |
9849094245 |
| Fax |
|
| Email |
pravin@lvpei.org |
|
|
Source of Monetary or Material Support
|
| Gebauer Medizintechnik GmbH, Monbachstraße 7/1, Neuhausen, Germany - 75242 |
|
|
Primary Sponsor
|
| Name |
Mr Steffen Gebauer |
| Address |
GEBAUER MEDIZINTECHNIK GmbH Monbachstrasse 7/1, Neuhausen, Germany - 75242 |
| Type of Sponsor |
Other [Medical Technology Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pravin Krishna V |
L V Prasad Eye Institute |
Department of Ophthalmology, Kallam Anji Reddy Campus, L V Prasad Marg, Road No. 2, Banjara Hills,
Hyderabad, - 500034
Telangana, India.
Hyderabad
TELANGANA |
9849094245
pravin@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| L V Prasad EyeInstitute EthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H524||Presbyopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Xenia Corneal Implant |
Xenia for Presbyopia is a custom-made corneal Implant made of collagen of porcine origin having a diameter of 1.8mm Maximum thickness of about 35micrometer. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or Female Subjects having Age between 40 years and above.
2.Willing to provide voluntary written consent.
3.No diagnosis of glaucoma, ocular hypertension, and severe dry eye disease
4.Having Presbyopia and having no or very marginal remaining accommodation capability or Pseudophake patients with standard (mono-focal) IOL
5.Emmetropic patients (or minimally myopic patients)
6.Needing about +1.5 diopters add for near vision
7.Must be able to tolerate Monovision of at least 1.5 diopters
8.Must be accessible and willing to attend all follow-up visits |
|
| ExclusionCriteria |
| Details |
1.Patients with IOP less than 10 mmHg or more than 21 mmHg.
2.Implanted with presbyopia-correcting IOLs (EDOF or Multifocal)
3.Prior LASIK or other corneal surgery
4.History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems.
5.Metabolic problems, e.g., diabetes or inflammatory concerns
6.Corneal scarring
7.Active infection of the cornea
8.Subject with history of neurotrophic cornea.
9.Subject with history of persistent corneal erosion difficulties with epithelial growth (re-epithelization)
10.Pregnancy and lactation.
11.History of previous ophthalmologic surgery on the operative eye.
12.Patients with amblyopia (VA less than 20/200 for the contralateral eye).
13.Patients with an uncooperative disposition.
14.Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days.
15.Other factors considered unsuitable by Investigator.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Safety Outcome- The frequency and severity of all treatment-related adverse events, during and post implantation of Xenia™ 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.
Primary Effectiveness Outcome- Change in Distance-corrected near visual acuity (DCNVA) compared to baseline (Achievement of a greater or equal to 3-line (15 letters) gain from baseline in DCNVA at 40 cm with no loss in CDVA greater or equal to 1-line (5 letters) at 4 m Month 1 post implantation) |
Day 1-3, 7, 14
Month 1, 3, 6, 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.No significant change in keratometry parameters (measured on pentacam) [Time Frame: 3 Months]
2.Subjective corneal clarity
3.No change in BDVA (Best Distance Visual Acuity)
4.Patient satisfaction |
Day 1-3, 7, 14
Month 1, 3, 6, 12 |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
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 4 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Gebauer Medizintechnik GmbH has
developed Xenia™ custom made corneal implant that will be used to treat presbyopia.
Xenia™ is an acellular porcine corneal stromal collagen scaffold which has been
cleared of all donor’s cells and its cellular remnants, as for example lipids,
peptides, sugars or kernel content as DNA.
Previous studies have shown
immunological safety of the Xenia™ material (natural corneal
collagen of porcine origin).
Patients taking part in the study can
significantly benefit from the procedure in that their near vision is restored
with a minimally invasive surgical procedure (much less invasive as compared to
implantation of presbyopia-correcting IOL).
The double rationale of using Xenia™ is
1.
thicken the pathological cornea using material
which is almost identical in structure and composition to the corneal
stroma improving the BCVA.
2.
support the cornea
as a whole preventing the progression of presbyopia.
The procedure is an additive procedure
as well as reversible, i.e., the implant can be removed and the initial vision
from before the implantation is restored. Due to the transparency of the
cornea, the implant can be always visualized, which is beneficial for
monitoring purposes. This is a Post Marketing Clinical Follow Up (PMCF) to
study the safety and indicative effectiveness of Xenia™, which is a custom-made
corneal Implant |