Implantable device for treating advanced keratoconus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a novel intra-corneal nitinol device, known as the GROSSO® implant, designed for patients with advanced keratoconus. The device is a permanent implant that modifies corneal shape to improve vision by being surgically inserted into the cornea. The study focuses on adults with stage 3-4 keratoconus who are not suitable for other treatments and are recommended for keratoplasty. Participants will be monitored for the device's performance and any adverse effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed and dated informed consent form.
* Male and female ≥ 18 years old.
* Not recommended for ICRS.
* Recommended for keratoplasty.
* Minimum corneal thickness ≥ 350 μm.
* Best Distance Spectacle Corrected Visual Acuity (BDSCVA) with the ETDRS test ≥ 0.30 logMAR (\<= 0,50 decimal notation).
* BCVA with RGP contact lens with the ETDRS test 10 letters or more than BCVA with spectacles.
* Have stable or stabilized disease for 12 months (in case of crosslinking, it must have been done at least 12 months prior to intervention).
* Have a KC stage 3-4 according to Investigator's judgement, with a central K readings \> 47.2 D and RMS of coma aberration \> 2.5 μm.
* Have no known or suspected allergy to nickel.
* Female subject of childbearing potential is eligible to participate if declaring she is not pregnant, or not breastfeeding and agree to use highly effective contraception (defined as method which results in a failure rate of \<1% annually) and must abstain from egg donation or storage throughout the study period.

Exclusion Criteria:

* Inability of patient and/or relatives to understand the clinical investigation procedures and thus inability to give informed consent.
* Untreated progressive KC.
* Single functioning eye.
* Other ocular diseases (eyelids malposition, uveitis, ocular hypertension, glaucoma, cataract, retinal disorders) or corneal surgeries (refractive corneal surgery, keratoplasty), except corneal crosslinking.
* Systemic collagenopathies and/or vasculitis, and other diseases that in the opinion of the principal Investigator, may be contraindicated.
* Suspected or known intolerance or hypersensitivity to any of the treatments indicated in the CIP and/or to any component of the device (i.e. nickel).

Where it's running

• Instituto de Microcirugía Ocular de Barcelona (IMO)
  Barcelona, Bar, Spain Recruiting
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  Roma, Roma, Italy Not yet recruiting

Study contacts

• Principal investigator: José L. Güell, MD — Head of the Cornea, Cataract and Refractive Surgery Department at IMO
• Study coordinator: Emiliano Lepore, Ing., PhD
• Email: el@recornea.com
• Phone: +39 3209673891

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Corneal Crosslinking to Treat Progressive Keratoconus or Corneal Ectasia

  This study tests two different light durations used in corneal crosslinking to see which better helps people with keratoconus or corneal ectasia.

  Recruiting Phase 2/3 Price Vision Group · Indianapolis, Indiana · NCT07841470

• Brillouin hydration mapping to study cornea health

  Researchers test a Brillouin microscope to see if it can measure corneal water content in healthy people and those with eye conditions.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07780890

• Same-day bilateral corneal cross-linking for keratoconus

  This trial tests whether performing corneal cross-linking in both eyes on the same day is safe and feasible for people with keratoconus.

  Recruiting Phase 4 Glaukos Corporation · Westerville, Ohio · NCT07629557

• A Smart Aperture Lens to Help Keratoconus and Presbyopia

  This study tests the NOA lens, a custom scleral contact lens with a central aperture, to see if it improves vision for people with keratoconus and presbyopia.

  Recruiting at 2 sites Azalea Vision · Antwerp and 1 other locations · NCT07559188

• GLK-221 eye drops for keratoconus

  This trial will test whether twice-daily GLK-221 eye drops are safe and help adults aged 18–55 with keratoconus compared with a placebo.

  Recruiting Phase 2 Glaukos Corporation · Westerville, Ohio · NCT07400952

• Corneal wavefront-guided PRK plus epi-off CXL versus PTK plus epi-off CXL for keratoconus

  This trial tests whether adding corneal wavefront-guided PRK to epi-off corneal cross-linking gives better vision than PTK plus epi-off CXL in adults with keratoconus.

  Recruiting Instituto de Oftalmología Fundación Conde de Valenciana · Mexico City, Mexico City · NCT07372911

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.