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).

Prospective Post-Marketing Clinical Follow-Up (PMCF) Study to Evaluate the Performance of Custom-Made XENIA Corneal Implants for The Treatment of Presbyopia - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088660

Enrollment

Registered

2025-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H524- Presbyopia

Interventions

Intervention1: 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. Contr

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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)Timepoint: Day 1-3, 7, 14 Month 1, 3, 6, 12	—

Measure

Time frame

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)Timepoint: Day 1-3, 7, 14 Month 1, 3, 6, 12

—

Secondary

Measure	Time frame
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 satisfactionTimepoint: Day 1-3, 7, 14 Month 1, 3, 6, 12	—

Countries

India

Contacts

Public ContactDr Pravin Krishna V

Hyderabad Eye Research Foundation, L V Prasad Eye Institute

pravin@lvpei.org9849094245

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026