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

Launched by FUNDACIO DE RECERCA DEL INSTITUTO DE MICROCIRUGIA OCULAR · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the GROSSO® implant, designed to treat advanced keratoconus, a condition that affects the shape of the cornea in the eye. The trial aims to find out if this implant is safe and effective for people who are not suitable for other treatments like corneal surgery. They are currently looking for participants who are at least 18 years old, have specific vision requirements, and have had stable keratoconus for the past year.

If you or someone you know is considering joining this study, you should be aware that participants will need to sign a consent form and will be closely monitored throughout the trial. The study is open to both men and women, but certain health conditions or previous eye surgeries may prevent eligibility. This is an exciting opportunity to potentially benefit from a new treatment option for keratoconus while helping researchers learn more about this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female ≥ 18 years old
• • Not suitable for ICRS and are recommended for keratoplasty
• • Best distance spectacle corrected visual acuity (BDCSVA) 1.30 - 0.40 logMAR (0.05-0,40 decimal notation)
• • Have stable or stabilized disease for 12 months (in case of cross-linking, it must have been done 12 months prior to intervention)
• • Have a KC stage 3-4 (Amsler-Krumeich) with a Central K readings \> 53.00 D and RMS of coma aberration \> 3.5.
• • Signed and dated informed consent form
• 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
• • Minimum Corneal thickness \< 400 μm
• • 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