Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus (LinkCor)
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|ClinicalTrials.gov Identifier: NCT04653922|
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : June 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus||Device: LinkCor Bioengineered Corneal Implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: Bioengineered corneal substitute
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 [ Time Frame: 6 months ]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.
- Corneal curvature measured by keratometry (efficacy measure) [ Time Frame: 6 months ]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.
- Central corneal thickness measured by topography techniques (efficacy measure) [ Time Frame: 6 months ]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.
- Visual acuity (efficacy measure) [ Time Frame: 6 months ]Vision improvement equivalent of minimum one line in Snellen chart in uncorrected distance visual acuity (UDVA) or corrected distance visual acuity (CDVA).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653922
|Contact: Mehrdad Rafat, PhDfirstname.lastname@example.org|
|Contact: Neil Lagali, PhD||+46 700 850 email@example.com|
|All India Institute of Medical Sciences, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS,||Recruiting|
|New Delhi, India, 110029|
|Contact: Namrata Sharma, MD, DNB +91-011-26593144 firstname.lastname@example.org|
|Iran, Islamic Republic of|
|Farabi Eye Hospital, Tehran University of Medical Sciences||Recruiting|
|Tehran, Iran, Islamic Republic of, 13366|
|Contact: Mahmoud Jabbarvand Behrouz, MD +989121014161 email@example.com|
|Principal Investigator:||Namrata Sharma, MD||ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi|
|Principal Investigator:||Mahmoud Jabbarvand Behrouz, MD||University of Tehran, Farabi Eye Hospital|