OCT-guided LALAK for KCN
Stopped early · Not applicable
Conditions studied: Corneal Opacity, Keratoconus
In brief
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.
Key facts
- Study ID
- NCT01901614
- Run by
- Oregon Health and Science University
- People needed
- 5
- Starts
- 2013-08-01
- Expected to finish
- 2017-08-31
- Last updated by the study team
- 2019-01-23
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- Preoperative corneal thickness less than 400 microns.
- Corneal edema
- Central guttata
- Inability to give informed consent.
- Inability to maintain stable fixation for OCT imaging.
- Inability to commit to required visits to complete the study.
- Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
- Patients with severe collagen vascular diseases or ocular surface disorders
Where it is running
- Casey Eye Institute, Oregon Health & Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.