TerminatedNot Applicable

A Clinical Study to Evaluate the KeraKlear Keratoprosthesis in Patients With Corneal Opacity

Stopped: KeraMed is being discontinued because it is no longer feasible due to the slow pace of recruitment and insufficient financial resources.

United States11 participantsStarted 2018-03-22

Plain-language summary

To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis when implanted in an eye with corneal opacity that is at high risk of complications with PK.

Who can participate

Age range22 Years – 80 Years

SexALL

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Inclusion criteria

✓. severe limbal stem cell deficiency (LSCD) associated with aniridia or
✓. one full-thickness graft failure and at high risk of a failed second graft; specifically, those who have either young recipient age (age less than 40 years), a history of anterior segment surgery (in addition to prior PKP), and/or pre-operative glaucoma or
✓. multiple (two or more) failed cornea transplantation surgeries and spontaneous visual improvement without surgical intervention is not expected or probable.

What they're measuring

Improvement in BCDVA compared to baseline

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12

Trial details

NCT IDNCT03126903

SponsorKeraMed, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-30

View on ClinicalTrials.gov More Corneal Blindness trials