Randomized Clinical Trial of OCT-Guided Laser-Assisted Lamellar Anterior Keratoplasty in Adults for Stromal Opacities
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- BSCVA (Snellen chart)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Preoperative corneal thickness less than 400 microns.
- •Inability to give informed consent.
- •Corneal edema
- •Central guttata
- •Inability to maintain stable fixation for OCT imaging.
- •Inability to commit to required visits to complete the study.
- •Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
- •Patients with severe collagen vascular diseases or ocular surface disorders
研究组 & 干预措施
LALAK
laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
干预措施: LALAK (Procedure)
LALAK
laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
干预措施: Retrobulbar Block or General Anesthesia (Drug)
LALAK
laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
干预措施: optical coherence tomography (OCT) (Device)
LALAK
laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
干预措施: Topical Anesthesia (Drug)
LALAK
laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
干预措施: femtosecond laser (Device)
IEK
Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.
干预措施: IEK (Procedure)
IEK
Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.
干预措施: Retrobulbar Block or General Anesthesia (Drug)
IEK
Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.
干预措施: femtosecond laser (Device)
结局指标
主要结局
BSCVA (Snellen chart)
时间窗: 24 months
A primary outcome measures will be BSCVA (Snellen chart)
intraoperative perforation rate
时间窗: 24 months
A primary outcome measure will be intraoperative perforation rate.
次要结局
- postoperative refractive error(24 months)
- topographic astigmatism(24 months)
- interface clarity(24 months)
- endothelial cell count(24 months)
- complications(24 months)
研究者
David Huang
Winston Chamberlain, MD, PhD, Assistant Professor of Ophthalmology
Oregon Health and Science University