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Lab-Grown corneal implant offers hope for advanced keratoconus

NCT ID NCT04653922

Disease control Sponsor: LinkoCare Life Sciences AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early safety study tested a bioengineered corneal implant called LinkCor in 20 adults with advanced keratoconus, a condition that thins and bulges the cornea. The implant is placed inside the cornea to flatten it and improve vision, without needing human donor tissue. Researchers checked for rejection and measured changes in corneal shape and eyesight over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LinkCor bioengineered corneal implant
What this could lead to
If successful, this implant could offer a less invasive treatment for advanced keratoconus that does not rely on scarce human donor corneas.
What could go wrong
This is a very early, small safety study with only 20 participants. The implant may fail to improve vision or could be rejected, requiring removal.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Nov 2016

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Advanced keratoconus (according to Amsler-Krumeich classification) * No corneal scar * Male or female aged ≥ 18 years, no upper age limit * Subjects indicated for a first corneal stromal transplantation (treatment naïve) * Corneal thickness (including epithelium) at least 300µm centrally, as measured by OCT. * Patients who gave their written signed and dated informed consent for participation Exclusion Criteria: * Prior corneal surgery (e.g., refractive surgery, cataract, collagen cross-linking, endothelial keratoplasty, etc.) * Dry eye / tear film pathology * Active ocular infection * Glaucoma / ocular hypertension * Active corneal ulceration * Acute or chronic disease or illness that would increase the operation risk or confound the outcomes of the study (immune- compromised, connective tissue disease, clinically significant atopic disease, etc.) * Any other medical condition that in the judgment of the clinical investigator or corneal surgeon is not compatible with the study procedures * General history judged by the investigator to be incompatible with the study (e.g., life-threatening patient condition, other condition where postoperative follow-up may be difficult). * known diabetes or other neuro-degenerative disorder (as corneal nerves can be affected leading to impaired wound healing) * Inability of patient to understand the study procedures and thus inability to give informed consent. * Participation in another clinical study within the last 3 months * Already included once in this study (can only be included for one treated eye).

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Conditions

The condition(s) this trial relates to.

keratoconus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Keratoconus

Contacts and locations

Locations

  • All India Institute of Medical Sciences, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS,

    New Delhi, 110029, India

  • Farabi Eye Hospital, Tehran University of Medical Sciences

    Tehran, 13366, Iran

More trials for these conditions

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