An interventional study of LinkCor Bioengineered Corneal Implant in Keratoconus, sponsored by LinkoCare Life Sciences AB. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by LinkoCare Life Sciences AB · Not applicable, Interventional, and Treatment
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.
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.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →LinkoCare Life Sciences AB is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
A cell-free, sterilized bioengineered corneal substitute made from medical grade collagen
Device: LinkCor Bioengineered Corneal Implant
Intrastromal implantation of a bioengineered corneal equivalent device
Safety outcome measure
The primary safety endpoint is defined such that a rejection leading to implant removal should occur in no more than 10% of implanted eyes. The implant rejection is defined as a clinical situation when the implanted eye has decreased central corneal clarity and decreased implant clarity, corneal vascularization inside of laser created pocket and inflammation.
Time frame: 6 months
Corneal curvature measured by keratometry (efficacy measure)
The maximum and minimum corneal curvature (steepness) of each eye will be measured by a keratometer and reported in diopter (D) unit and represented as "K-value". The efficacy outcome is that more than 60% of the eyes should have a decrease in K-value at 6 months postoperatively.
Time frame: 6 months
Central corneal thickness measured by topography techniques (efficacy measure)
Central corneal thickness (CCT) will be measured in microns and reported using a two-dimensional thickness map made by optical coherence tomography (OCT) and/or Pentacam topography. The efficacy outcome is that more than 60% of the eyes should have an increase in CCT at 6 months postoperatively.
Time frame: 6 months
Visual acuity (efficacy measure)
Vision improvement equivalent of minimum one line in Snellen chart in uncorrected distance visual acuity (UDVA) or corrected distance visual acuity (CDVA).
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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LinkoCare Life Sciences AB