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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 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.
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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 |
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| Measure | Description | Time Frame |
|---|---|---|
| BSCVA (Snellen chart) | A primary outcome measures will be BSCVA (Snellen chart) | 24 months |
| intraoperative perforation rate | A primary outcome measure will be intraoperative perforation rate. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative refractive error | A secondary outcome measures will be postoperative refractive error | 24 months |
| topographic astigmatism | A secondary outcome measures will be topographic astigmatism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Winston Chamberlain, MD, PhD | Casey Eye Institute, Oregon Health & Science University | Principal Investigator |
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| Label | URL |
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| Related Info | View source |
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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 |
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| Retrobulbar Block or General Anesthesia | Drug |
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| optical coherence tomography (OCT) | Device | 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. |
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| Topical Anesthesia | Drug |
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| 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. |
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| 24 months |
| interface clarity | A secondary outcome measures will be interface clarity (masked OCT and confocal microscopy grading) | 24 months |
| endothelial cell count | A secondary outcome measures will be endothelial cell count (specular microscopy) | 24 months |
| complications | A secondary outcome measures will be complications (rejection, interface opacification, others). | 24 months |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |