OCT-guided LALAK for KCN

• Status: Terminated
• Trial end date: 2017-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if a new procedure, called laser-assisted lamellar anterior keratoplasty (LALAK), can achieve the same level of vision with a lower risk of potential complications after surgery compared to another corneal transplant procedure. The current procedure is called Intralase-enabled keratoplasty (IEK) and replaces the entire cornea.

The LALAK procedure involves transplanting only the top layers of the cornea instead of the entire cornea. Only one eye will have this experimental procedure performed. If both eyes need to have surgery your doctor will help you decide on the best non-study option for your other eye.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborators: National Eye Institute (NEI); National Institutes of Health (NIH)
• Treatments: Anesthetics

Criteria

Inclusion Criteria:

• Eyes with keratoconus that cannot be adequately or safely corrected with spectacles, contact lens or excimer laser surface ablation. The cornea must have healthy endothelium (endothelial cell density > 1,500/mm2).

Exclusion Criteria:

1. Preoperative corneal thickness less than 400 microns.

2. Corneal edema

3. Central guttata

4. Inability to give informed consent.

5. Inability to maintain stable fixation for OCT imaging.

6. Inability to commit to required visits to complete the study.

7. Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.

8. Patients with severe collagen vascular diseases or ocular surface disorders