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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY018184 | U.S. NIH Grant/Contract | View source |
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Modifying procedure
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Eye Institute (NEI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LALAK | Experimental | laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used. |
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| IEK | Active Comparator | Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LALAK | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Does LALAK Achieve the Same Level of Post-operative BSCVA as IEK. | The primary goal of the trial is to determine if LALAK can achieve the same level of postoperative Best Spectacle Corrected Visual Acuity (BSCVA) guided by OCT as IEK. The BSCVA will be measured using a clinic Snellen chart and recorded in the typical Snellen fraction (20/xx) in feet. This will be converted to logMAR form for statistical analysis. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Winston Chamberlain, MD, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casey Eye Institute, Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser-assisted Lamellar Anterior Keratoplasty | Laser-assisted lamellar anterior keratoplasty LALAK: a. 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. b. 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 FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. 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). |
| FG001 | Intralase-enabled Keratoplasty | Intralase-enabled keratoplasty. IEK: a. 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. b. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser-assisted Lamellar Anterior Keratoplasty | LALAK: a. 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. b. 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 FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Does LALAK Achieve the Same Level of Post-operative BSCVA as IEK. | The primary goal of the trial is to determine if LALAK can achieve the same level of postoperative Best Spectacle Corrected Visual Acuity (BSCVA) guided by OCT as IEK. The BSCVA will be measured using a clinic Snellen chart and recorded in the typical Snellen fraction (20/xx) in feet. This will be converted to logMAR form for statistical analysis. | For the LALAK group, there were 3 subjects enrolled, but one was a screen fail so no data was obtained for that subject. | Posted | Mean | 95% Confidence Interval | logMAR unit | 24 months |
|
Data was collected up to 24-months from the date of surgery.
See data tables for adverse event information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laser-assisted Lamellar Anterior Keratoplasty | LALAK: a. 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. b. 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 FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revert to keratoconus pattern | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Huang, MD, PhD | Oregon Health & Science University | 503-494-3000 | huangd@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2015 | Nov 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003318 | Corneal Opacity |
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D041623 | Tomography, Optical Coherence |
| D000758 | Anesthesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
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|
| IEK | Procedure |
|
|
| Retrobulbar Block or General Anesthesia | Drug |
|
| optical coherence tomography (OCT) | Device | OCT will be used to guide the depth of the graft and donor dissections. |
|
| Topical Anesthesia | Drug |
|
| femtosecond laser | Device | 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. |
|
| Screen Fail |
|
| BG001 | Intralase-enabled Keratoplasty | IEK: a. 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. b. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Intralase-enabled Keratoplasty | IEK: a. 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. b. 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. |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Intralase-enabled Keratoplasty | IEK: a. 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. b. 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| Corneal epithelial defect with interface haze | Eye disorders | Systematic Assessment |
|
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| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |