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First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

NCT06451718 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-01-20

No results posted yet for this study

Summary

This Study is a First In Human clinical investigation addressed to evaluate the safety and efficacy of a novel intra-corneal nitinol device (Investigational Medical Device: GROSSO® implant) for the treatment of advanced keratoconus disease of the eye.

Conditions

  • Keratoconus

Interventions

DEVICE

Nitinol net for intracorneal implant for keratoconus treatment

The investigational corneal implant device is designed for patients with keratoconus. It is intended to be surgically implanted into the cornea as a permanent implant and is made of nitinol. The device is intended to improve corneal stability and visual outcomes.

Sponsors & Collaborators

  • Recornea Srl

    lead INDUSTRY

Principal Investigators

  • Edoardo Grosso, MD · Chief Medical Officer (CMO)

  • José L. Güell, MD · Head of the Cornea, Cataract and Refractive Surgery Department at IMO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06451718 on ClinicalTrials.gov