NCT04653922

Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus

Evaluation of Safety and Efficacy of Intrastromal Implantation of LinkCor Bioengineered Corneal Implant for Management and Treatment of Keratoconus: a Prospective, Non-randomized, Non-controlled Case Series.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: LinkoCare Life Sciences AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, Phase I open-label safety study to evaluate the safety, feasibility and initial efficacy of a bioengineered corneal stromal substitute after implantation into the stroma of adults with advanced keratoconus. The bioengineered substitute and implantation technique may provide a less invasive treatment option for advanced keratoconus than current surgical approaches, that additionally does not rely on the limited availability of human donor corneal tissue.

Detailed description

This is a Phase I, open-label, non-randomized, non-controlled ongoing clinical case series in two participating centers in Indian and Iranian hospitals, to evaluate the safety and feasibility of minimally-invasive surgery of advanced keratoconus using a bioengineered corneal stromal substitute on a compassionate basis to alleviate blindness and low vision, due to the severely limited availability of human corneal donor tissue at these centers relative to the medical need. Patients fulfilling inclusion criteria are recruited consecutively and implanted intra-stromally with the bioengineered substitute, as a less invasive surgery than full-thickness or anterior lamellar corneal transplantation. In the first phase of the study, a total of 20 patients were recruited and safety and efficacy outcomes were evaluated in those having a minimum of 12 months of postoperative follow-up. In the second phase of the study (currently ongoing), up to 40 patients are being recruited, with one-year postoperative outcomes of all included patients to be evaluated as the final study endpoint. Primary safety and efficacy outcomes will be evaluated.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DEVICE	LinkCor Bioengineered Corneal Implant	Intrastromal implantation of a bioengineered corneal equivalent device

Timeline

• Start date: 2016-11-01
• Primary completion: 2022-12-31
• Completion: 2023-07-31
• First posted: 2020-12-04
• Last updated: 2025-09-09

Locations

2 sites across 2 countries: India, Iran