Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-07-31
2017-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LALAK
laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
LALAK
1. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. High-quality graft will be replaced in preservation medium and shipped to the surgeon prior to surgery.
2. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The femtosecond laser treatments will be performed under topical anesthesia in the laser suite. The femtosecond laser is an FDA-approved device for use in this indication (corneal transplantation including lamellar keratoplasty). A protective eye shield is placed over the eye. The graft will be sutured into the host bed.
Retrobulbar Block or General Anesthesia
optical coherence tomography (OCT)
OCT will be used to guide the depth of the graft and donor dissections. The OCT systems to be used in this study will be the RTVue (Optovue, Inc., Fremont, CA) or the Visante (Carl Zeiss Meditec, Inc., Dublin, CA). Both are FDA-approved for the mapping of corneal thickness.
Topical Anesthesia
femtosecond laser
The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
IEK
Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.
IEK
1. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery.
2. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed.
Retrobulbar Block or General Anesthesia
femtosecond laser
The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
Interventions
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LALAK
1. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. High-quality graft will be replaced in preservation medium and shipped to the surgeon prior to surgery.
2. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The femtosecond laser treatments will be performed under topical anesthesia in the laser suite. The femtosecond laser is an FDA-approved device for use in this indication (corneal transplantation including lamellar keratoplasty). A protective eye shield is placed over the eye. The graft will be sutured into the host bed.
IEK
1. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery.
2. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed.
Retrobulbar Block or General Anesthesia
optical coherence tomography (OCT)
OCT will be used to guide the depth of the graft and donor dissections. The OCT systems to be used in this study will be the RTVue (Optovue, Inc., Fremont, CA) or the Visante (Carl Zeiss Meditec, Inc., Dublin, CA). Both are FDA-approved for the mapping of corneal thickness.
Topical Anesthesia
femtosecond laser
The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
100 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Eye Institute (NEI)
NIH
Oregon Health and Science University
OTHER
Responsible Party
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David Huang
Winston Chamberlain, MD, PhD, Assistant Professor of Ophthalmology
Principal Investigators
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Winston Chamberlain, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Casey Eye Institute, Oregon Health & Science University
Related Links
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Related Info
Other Identifiers
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OHSU IRB#00009282
Identifier Type: -
Identifier Source: org_study_id
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