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

NCT04653922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-09

No results posted yet for this study

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.

Conditions

  • Keratoconus

Interventions

DEVICE

LinkCor Bioengineered Corneal Implant

Intrastromal implantation of a bioengineered corneal equivalent device

Sponsors & Collaborators

  • LinkoCare Life Sciences AB

    lead INDUSTRY

Principal Investigators

  • Namrata Sharma, MD · ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi

  • Mahmoud Jabbarvand Behrouz, MD · University of Tehran, Farabi Eye Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2022-12-31
Completion
2023-07-31

Countries

  • India
  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04653922 on ClinicalTrials.gov