We are excited to start enrolling patients in a new US clinical trial evaluating CHEC, a revolutionary treatment for Fuchs’ dystrophy and other causes of corneal edema. CHEC is revolutionary because it expands the supply of donor tissue, potentially allowing 100 or more patients to be treated with healthy cells from a single donor cornea, whereas keratoplasty requires a donor cornea for each recipient. CHEC is also revolutionary in terms of streamlining surgery and early postop care. This innovative treatment was developed in Japan where the initial patients have over 9 years of follow up with no graft rejection episodes or late graft failure.  Candidates for this study must have best corrected vision of 20/50 or worse, be pseudophakic, and have at least one eye that has not received a cornea transplant. Participants can have one eye treated in the study and will be followed for 1 year. This study could dramatically change corneal surgery and treatment of endothelial dysfunction.

If you have a patient you feel may benefit from this study, please email study@cornea.org or call 317-814-2997.

To better understand how Fuchs’ dystrophy progresses over time in individual patients, we are participating in a study that provides 3 annual comprehensive eye exams for patients with any stage of Fuchs’ Dystrophy (early to late) who have not yet had a cornea transplant in both eyes.  There are no interventions or medications involved.  The findings from this study will provide the foundation for future studies of a potentially ground-breaking biologic treatment to address the underlying genetic defect and avoid the need for a transplant.

If you have a patient you feel may benefit from this study, please email study@cornea.org or call 317-814-2997.

Currently, about 30% of cornea donors are known to have had diabetes, and we don’t know whether this affects transplant success, so we are conducting a multicenter study to find out. In this study, the eye bank does a more detailed assessment of the donor’s medical record than usual, plus they collect blood for HbA1c testing and collect a skin biopsy to assess blood sugar control for up to 5 years before death.  From the patient’s perspective, this is a data collection study – they receive our optimized DMEK procedure and postop care. Participants need to see us for the 1-month and 1-year exams and can follow up with you for other visits.

If you have a patient you feel may benefit from this study, please email study@cornea.org or call 317-814-2997.

We need better approaches to rapidly identify ocular pathogens and initiate appropriate treatment, so we are excited to participate in the international CAPRICORN study to evaluate a deep RNA sequencing approach. We currently use DNA PCR for rapid pathogen analysis, but PCR only looks for specific organisms, whereas CAPRICORN has much broader diagnostic power to determine if bacteria, fungus, or protozoa are present plus identify specific species. From the patient’s perspective, the study just involves taking a scraping as we typically do with corneal ulcers and collecting one month follow up information. This diagnostic technique is not yet FDA approved, so patients also receive standard of care diagnosis and treatment.

If you have a patient you feel may benefit from this study, please email study@cornea.org or call 317-814-2997.

We are evaluating a new human mesenchymal stem cell eye drop treatment for stage 1-3 neurotrophic keratitis. Participants are randomized to 1 of 2 concentrations or placebo for 8 weeks and can be rescued with active drug thereafter. Potential benefits for participants are receiving treatment at no cost and compensation for completing the study visits.

If you have a patient you feel may benefit from this study, please email study@cornea.org or call 317-814-2997.

We are actively enrolling patients in a study comparing standard vs. accelerated epithelium off corneal crosslinking for keratoconus and corneal ectasia.  We are also enrolling patients in a study evaluating crosslinking for corneal neovascularization with or without concomitant corneal infection. Crosslinking has shown promise for vascularized eyes needing or having had a corneal transplant.  All patients receive active crosslinking treatment.

If you have a patient you feel may benefit from this study, please email study@cornea.org or call 317-814-2997.

The FDA recently approved the Apthera™ IOL with a central pinhole for implantation in the near eye of patients who would like monovision after cataract surgery. As in standard monovision, the dominant eye receives a distance monofocal or light-adjustable lens.  The Apthera™ provides excellent near vision plus good distance vision in the near eye allowing depth perception, which is typically impossible with true monovision. A 3.25-mm diameter black ring with a clear periphery surrounds the central 1.3-mm clear zone. The Apthera™ lens can also be implanted off-label to effectively reduce visual distortion in eyes with irregular astigmatism, such as after radial keratotomy. We are enrolling patients in a post-approval study to evaluate YAG capsulotomy in normal eyes that were implanted with an Apthera™ lens for monovision. Patients are compensated for participation.

If you have a patient you feel may benefit from this study, please email study@cornea.org or call 317-814-2997.

We are evaluating twice daily use of investigational eye drops for dry eye disease. Participants must have both corneal and conjunctival staining and are randomized to an active drug or placebo. Participants are compensated for completing 6 visits over 14 weeks.

If you have a patient you feel may benefit from this study, please email study@cornea.org or call 317-814-2997.