OCT-guided LALAK for KCN
| Status: | Terminated |
|---|---|
| Conditions: | Ocular, Ocular, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 1/25/2019 |
| Start Date: | August 2013 |
| End Date: | August 31, 2017 |
RANDOMIZED CLINICAL TRIAL OF OCT-GUIDED LASER-ASSISTED LAMELLAR ANTERIOR KERATOPLASTY IN ADULTS FOR KERATOCONUS
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.
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.
Corneal transplantation (keratoplasty) is the most common organ transplant, with 42,606
procedures in the U.S. in 2009. Many surgeons are moving away from full thickness corneal
transplantation, also called penetrating keratoplasty (PK), because of risks involving
rejection, irregular astigmatism and wound dehiscence. They are moving towards partial
thickness (lamellar) transplantations of either the anterior or posterior (endothelial)
layers, which can reduce these risks.
The femtosecond laser has been used to create excellent tongue-in-groove junctions between
the graft and host in full thickness PK.1 This technique, called IEK (Intralase-enabled
keratoplasty), has now become a standard surgical procedure. The tongue-in-groove junction
achieved at the circumferential edge of the graft and host leads to a continuous smooth
anterior surface and strong wound healing.
The new technique is called dovetail LALAK. In this technique, the femtosecond laser is used
to create a 31% anterior lamellar graft with dove tailed side cuts. It is also used to create
a shallow anterior lamellar dissection and beveled side cuts on the recipient cornea to match
with the dovetail graft.
In the new technique, the depth of the graft and donor dissections will be guided by OCT
measurements. The proposed trial will test if the new technique can reproducibly achieve good
visual outcomes without the risk of rejection. The outcome of the LALAK procedure will be
compared to that of IEK.
procedures in the U.S. in 2009. Many surgeons are moving away from full thickness corneal
transplantation, also called penetrating keratoplasty (PK), because of risks involving
rejection, irregular astigmatism and wound dehiscence. They are moving towards partial
thickness (lamellar) transplantations of either the anterior or posterior (endothelial)
layers, which can reduce these risks.
The femtosecond laser has been used to create excellent tongue-in-groove junctions between
the graft and host in full thickness PK.1 This technique, called IEK (Intralase-enabled
keratoplasty), has now become a standard surgical procedure. The tongue-in-groove junction
achieved at the circumferential edge of the graft and host leads to a continuous smooth
anterior surface and strong wound healing.
The new technique is called dovetail LALAK. In this technique, the femtosecond laser is used
to create a 31% anterior lamellar graft with dove tailed side cuts. It is also used to create
a shallow anterior lamellar dissection and beveled side cuts on the recipient cornea to match
with the dovetail graft.
In the new technique, the depth of the graft and donor dissections will be guided by OCT
measurements. The proposed trial will test if the new technique can reproducibly achieve good
visual outcomes without the risk of rejection. The outcome of the LALAK procedure will be
compared to that of IEK.
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
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