Corneal transplantation studies include participation in national surgical outcomes database development and a new artificial cornea medical device.
AlphaCor Artificial Cornea Device for cornea transplant patients who reject human tissue
Do You Qualify?
The cornea is the clear, dome-shaped tissue that covers the front surface of your eye. Light rays enter the eye through the cornea, which is the main focusing element of the eye. The cornea bends the light rays through your pupil. A healthy cornea is clear and brings light into a sharp focus inside the eye. Corneal tissue may become damaged either through accidents, infections, or genetic defects. Damaged corneal tissue may become cloudy or irregularly shaped, resulting in visual impairment because of a reduction in light passage through the tissue. Corneal transplant surgery may be performed to replace damaged corneal tissue with tissue from a human donor. Though success rate is high, donor tissue may fail after surgery in some patients. In such patients, a man-made cornea implant may be used.
The AlphaCor artificial cornea device (AlphaCor device) is a medical device made of from a solid, flexible material and is designed to replace a donor corneal tissue graft that failed from a previous surgery.
This AlphaCor device was approved by the Food and Drug Administration (FDA) in August of 2002; therefore, this is a non-investigational research study designed to further examine ongoing device results of the AlphaCor device versus repeat corneal transplantation using human donor tissue in patients who have failed prior cornea transplants. By participating in the study, participants agree to allow information collected during the preoperative, surgical, and 3-, 6-, 9-, and 12-month postoperative visits to be submitted to the study sponsor in an anonymous manner.
Summary of the Procedure
The AlphaCor device is implanted during a two-stage surgical procedure with approximately 12 weeks separating the two procedures.
- Stage I surgery: Under local or general anesthesia, the surgeon creates a small pocket of tissue within the outermost portion of your eye tissue. The surgeon then implants the AlphaCor device and sutures the pocket in place over the device.
- Stage II surgery: Approximately 12 weeks after the Stage I surgery, under local or general anesthesia, the surgeon removes some of the tissue from the front portion of the tissue pocket to expose the central part of the device and allow light to enter the eye.
Brief Eligibility Checklist
- Have an original pathology of bullous keratopathy, Fuchs’ or other dystrophy, keratoconus or non-herpetic scar
- Failed a previous donor tissue graft
- Judged by the surgeon to be at high risk of failure using donor tissue based on overall clinical status, including vascularization, history of glaucoma etc, for a further graft to be offered
- Cataract, if present, must be removed in a separate, prior procedure
Participants are followed after surgery per the surgeon’s standard management plan, which includes the following approximate visit intervals:
- After Stage I surgery: Day 1, 2, 3, and 7, then 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks.
- After Stage II surgery: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, 12 months, 15 months, 18 months, and 24 months.
No study-specific visits are required.
Contact - firstname.lastname@example.org or call 612-813-3607
Study History- Cornea Transplantation
Jaeb Center for Health Research - Cornea Donor Study
A pilot clinical trial to evaluate the safety of optisol, a new medium for corneal preservation
Long-term follow-up and complications of LASIK after Penetrating Keratoplasty
Controlled trial of corneal preservation media containing human growth factor