First in Human Study to Assess the Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Stage 3 and 4 Keratoconus (KC)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This Study is a first in human clinical study addressed to evaluate the safety and efficacy of a novel intra-corneal nitinol device (Investigational Device; GROSSO® implant) for the treatment of advanced keratoconus disease of the eye.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Spain
Instituto de Microcirugía Ocular de Barcelona (IMO)
RECRUITING
Barcelona
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2025-12
Participants
Target number of participants: 12
Treatments
Experimental: Study group
Participants with study disease
Related Therapeutic Areas
Sponsors
Leads: Fundacio De Recerca Del Instituto De Microcirugia Ocular