LALAK for Opacities
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2013 |
| End Date: | August 2016 |
| Contact: | Janice Ladwig |
| Email: | ladwig@ohsu.edu |
| Phone: | 503-494-8024 |
Randomized Clinical Trial of OCT-Guided Laser-Assisted Lamellar Anterior Keratoplasty in Adults for Stromal Opacities
The purpose of this protocol is to compare and develop new surgical technique of
partial-thickness corneal transplantation for treating corneal opacity. A newly developed
technique, "dovetail" laser-assisted lamellar anterior keratoplasty (LALAK), will be tested
and compared with standard full-thickness corneal transplantation, Intralase-enabled
keratoplasty (IEK). The new LALAK technique replaces only the front portion of the cornea
and does not have the risks associated with conventional IEK. Additionally, optical
coherence tomography (OCT) will be used to guide the depth of the graft and donor
dissections.
The data will be analyzed to understand whether the new technique (LALAK) can repeatedly
achieve good visual outcomes with lower risk from the operation compared to the visual
outcomes and risk associated with the current standard of care, IEK.
partial-thickness corneal transplantation for treating corneal opacity. A newly developed
technique, "dovetail" laser-assisted lamellar anterior keratoplasty (LALAK), will be tested
and compared with standard full-thickness corneal transplantation, Intralase-enabled
keratoplasty (IEK). The new LALAK technique replaces only the front portion of the cornea
and does not have the risks associated with conventional IEK. Additionally, optical
coherence tomography (OCT) will be used to guide the depth of the graft and donor
dissections.
The data will be analyzed to understand whether the new technique (LALAK) can repeatedly
achieve good visual outcomes with lower risk from the operation compared to the visual
outcomes and risk associated with the current standard of care, IEK.
Inclusion Criteria:
- Eyes with corneal opacities 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. Inability to give informed consent.
3. Corneal edema
4. Central guttata
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
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