Corneal Tissue Inlay for Keratoconus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with moderate to severe keratoconus, a condition where the cornea thins and bulges outward, causing vision problems. The study evaluates whether placing preserved corneal tissue (corneal tissue inlay) into the affected cornea can improve its thickness, stability, and shape. This approach could enhance vision and reduce symptoms for those with the condition. Individuals diagnosed with moderate or severe keratoconus who experience vision issues may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new treatment options for keratoconus.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this corneal tissue inlay is safe for keratoconus?
Research has shown that corneal tissue inlays are generally well-tolerated. These inlays are considered permanent implants, remaining in the eye for more than 30 days. This treatment strengthens the cornea in individuals with keratoconus, a condition that alters the cornea's shape and clarity. Although specific side effects are not detailed in the available information, the "Not Applicable" phase indicates it is not a new or high-risk procedure. This status usually implies some prior evidence of safety, possibly from similar methods used for other conditions. Prospective clinical trial participants should discuss potential risks and benefits with their doctor.12345
Why are researchers excited about this trial?
Unlike the standard treatments for keratoconus, which often include rigid contact lenses or corneal transplants, the corneal tissue inlay offers a new approach by implanting a thin disc of preserved corneal tissue directly into the cornea. This method aims to provide structural support and stabilize the eye's shape without the need for more invasive surgery. Researchers are excited about this treatment because it could potentially offer a less invasive and more immediate solution, improving vision and slowing down the progression of keratoconus with fewer complications.
What evidence suggests that the corneal tissue inlay is effective for keratoconus?
Research has shown that corneal tissue inlays could help treat keratoconus, a condition where the cornea becomes thin and bulges outward. Studies have found that this procedure can improve vision and stabilize the cornea. In one study, patients' vision improved significantly, with their ability to see clearly with glasses going from very poor to much better. Additionally, the cornea's shape became flatter, indicating the treatment's effectiveness. These findings suggest that corneal tissue inlays might be a helpful treatment option for people with keratoconus.15678
Who Is on the Research Team?
Peter Hersh, MD
Principal Investigator
Cornea and Laser Eye Institute
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe keratoconus, a condition that affects the cornea of the eye. Participants must be willing to follow instructions and attend follow-up visits. Women cannot be pregnant to join. People with allergies to trial materials, mild or suspected keratoconus, history of slow corneal healing, other significant eye conditions, or recent participation in other trials are excluded.Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a corneal tissue inlay to treat keratoconus
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Corneal tissue inlay
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cornea and Laser Eye Institute
Lead Sponsor