Refractive Outcomes Evaluation of the Verion Image Guided System + ORA System With VerifEye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Residual Refractive Cylinder
研究概览
简要总结
Nowadays cataract patient's expectations are closer to those of refractive surgery patients. Patients want to be spectacle independent. However, fifteen to twenty percent of cataract surgery patients have from 1.00 to 3.00 diopters (D) of corneal astigmatism which makes achieving spectacle independence unlikely in this patients unless the astigmatism is treated at the time of cataract surgery. Option to treat this astigmatism include corneal or limbal incisions (LRIs), the use of toric intraocular lenses (IOLs) or LASIK. Regardless of the treatment of choice to correct the astigmatism at time of cataract extraction, a treatment plan has to be calculated preoperatively. This planning include: keratometry measurements and the use of a calculator to estimate the treatment and orientation of IOL and/or placement of the LRIs.
New technology has been developed and is widely used. Among this technology, we have the VERION Image Guided System. This system encompasses a reference unit that takes a picture of the eye with the patient in the sitting position creating image of the patient's eye, capturing scleral vessels, limbus and iris features. It measures keratometry as well as the corneal diameter (limbus) and pupil size. The information captured is transferred automatically to its planner where IOL power calculation and astigmatism correction calculation are completed. Additionally, intraoperative wavefront aberrometry has been used in the last couple of years with increase success.
详细描述
Nowadays cataract patient's expectations are closer to those of refractive surgery patients. Patients want to be spectacle independent. However, fifteen to twenty percent of cataract surgery patients have from 1.00 to 3.00 diopters (D) of corneal astigmatism which makes achieving spectacle independence unlikely in this patients unless the astigmatism is treated at the time of cataract surgery.
Currently available treatments include corneal or limbal incisions, the use of toric intraocular lenses (IOLs) or LASIK. Limbal relaxing incisions (LRIs) are the most commonly used manual method Traditionally, LRIs have been made manually (with a surgical knife). With the introduction of femtosecond laser to assist during cataract surgery, a new alternative is available for creating corneal incisions. The stability of the LRIs and visual outcomes using toric IOLs have been shown.
Regardless of the treatment of choice to correct the astigmatism at time of cataract extraction, a treatment plan has to be calculated preoperatively. This planning include: keratometry measurements and the use of a calculator to estimate the treatment and orientation of IOL and placement of the LRIs.
Keratometry can be measured using a variety of devices including manual keratometers (i.e. Javal-Shiotz), automated keratometers, corneal topography, and optical biometry ( IOL master and Lenstar).
Once keratometry to be used has been selected, if the treatment of choice are LRIs, a calculator is used to determine the location and size of the LRI. Many nomograms have been developed; the choice of nomogram is the surgeon's prefer one, usually based on prior experience, and their preferred knife. LRIs calculators are available on line. Nomograms specify the location, length, size, and number of incisions based on the patient's age, the type of astigmatism, and the amount of astigmatism correction needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is undergoing bilateral cataract extraction or refractive lens exchange with intraocular lens implantation and astigmatism correction.
- •Willing and able to provide written informed consent for participation in the study
- •Willing and able to comply with scheduled visits and other study procedures.
排除标准
- •Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- •Uncontrolled diabetes.
- •Use of any systemic or topical drug known to interfere with visual performance.
- •Contact lens use during the active treatment portion of the trial.
- •Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- •Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules
- •Previous refractive surgery.
- •Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
- •Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- •Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
研究组 & 干预措施
Conventional
Surgeon's standard of care prior to getting VERION. Spherical power will be selected using the surgeon's preferred formula (Haigis, Holladay 2, Holladay, or other) and biometry method (IOL Master, Lenstar). Astigmatism correction will be planned using the surgeon's preferred keratometry method and calculator/nomogram to determine toric power and corneal incisions (i.e. Alcon toric calculator, Holladay toric calculator, Abbott Medical Optics (AMO) LRI calculator, etc). At time of surgery, axis of placement will be marked using blue ink marks. Corneal incisions will be made manually.
干预措施: Conventional (Device)
Refractive Cataract Suite (Verion + ORA)
Digital Surgical Planning and Positioning Tools + ORA System with VerifEye or VerifEye +. Spherical power of the IOL will be selected using the Verion Planner with the surgeon's preferred formula with an optimized A-constant (Haigis, Holladay 2, Holladay, or other). Both toric lenses and corneal incisions will be calculated with the Verion Planner using the Verion Reference Unit keratometry and white to white measurements, and Lenstar biometry. The VERION Digital Markers L and M will be used for axis of placement and confirmed using ORA System with VerifEye or VerifEye +.
干预措施: Refractive Cataract Suite (Verion + ORA) (Device)
结局指标
主要结局
Residual Refractive Cylinder
时间窗: Three months
This is the manifest refractive cylinder measured 3 months after surgery. Note that because cataract surgery has been performed, there is no associated baseline value.
次要结局
- Residual Corneal Astigmatism(Three months)
- Residual Mean Spherical Equivalent Refraction(Three months)