Intraidivisual Comparison of Functional Vision Provided by AMO Tecnis Z9000 and ALcon SA60AT Acrysof Posterior Chamber Intraocular Lenses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition
研究概览
简要总结
This study is to compare intraindividually the functional vision provided by two different posterior chamber intraocular lenses: AMO Tecnis Z9000 and Alcon SA60AT Acrysoft. To see if the aspherical intraocular lenses provide better functional vision than traditional spherical intraocular lenses.
详细描述
In this prospective study, 20 patients with bilateral catarct presenting for cataract surgery are randomly assigned to recieve an aspherical intraocular lens(AMO Tecnis Z9000) in one eye and a spherical intraocular lens(Alcon SA60AT Acrysof)in the other. All surgeries are performed by one experienced surgeon(Fung-Rong Hu,MD)with clear cornea small incision phacoemulsification and in-the-bag posterior chamber intraocular implantation.
The patients are followed for 3 months, and postoperative contrast sensitivity, contrast acuity, corneal & total ocular high-ordered aberrations are measured and compared intraidividually between two different IOL groups.
Outcome Measurement:
- Contrast sensitivity testing: measured with spectacle correction for the target distance of three meters using wall-mounted FACT sine-wave grating chart with nine levels of contrast.The graphic contrast sensitivity is recorded as a log functional units on the y-axis and displayed for five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd))on x- axis.
- Contrast acuity testing: measured with spectacle correction for the target distance of three meters using logMAR letter chart(Precision Vision®)represented on a wall-mounted illuminator cabinet.Two types of contrast charts are used, high contrast(Cat.No.2103 SLOAN translucent chart)and low contrast(Cat.No.2132 10% SLOAN translucent chart),and are tested under both photopic and mesopic conditions.
- Pupil diameters: measured by Colvard infrared pupillometer (Oasis. Medical, Glendora, CA, USA )under both photopic and mesopic luminance levels.
- Corneal aberration analysis: performed with TMS-4 (Tomey, Japan).The corneal HOAs are described with Zernike polynomials of 3rd-to 5th- order root-mean-square(RMS)of central 6mm diameter using VOLPro 6.89 software(Fa. Sarver and Associates, Carbondale. Ill, USA).
- Total ocular aberration analysis: performed with a Hartmann-Shack aberrometer(Zywave, Bausch & Lomb Inc., Rochester, New. York)under maximal mydriasis with Mydrin-P(phenylephrine hydrochloride 0.5% and tropicamide 0.5%, Santen).The wavefront errors were described using Zernike polynomials RMS for total HOA at pupil diameter of 5 mm and 6 mm, primary spherical (Z 4,0) and 3rd-to 5th-order aberration at pupil diameter of 6 mm.
Data Analysis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilateral cataracts, eligible for phacoemulsification with primary implantation of a posterior chamber IOL
- •Willing and able to comply with scheduled visits and other study procedures
排除标准
- •Preoperative ocular pathology potentially affect visual acuity. EX: diabetic retinopathy, macular degeneration, corneal opacity, glaucoma, visual field defect...etc.
- •Previous ocular surgery. Ex: refractive surgery, vitreoretinal surgery...etc.
- •Patients who cannot cooperative with the study procedures
结局指标
主要结局
Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition
时间窗: average data of post-op 3rd, 6th, 12th week measurements
Contrast acuity testing was measured with spectacle correction for the target distance of three meters using a logMAR letter chart (Precision Vision®) represented on a wall-mounted illuminator cabinet. Two types of contrast charts were used, high contrast (Cat.No.2103 SLOAN translucent chart) and low contrast (Cat.No.2132 10% SLOAN translucent chart), and these were tested under both photopic (250 Lux) and mesopic (0.5 Lux) conditions. The contrast acuity tested ranges from 20/160 to 20/20(from worse to best), which equals LogMAR(Logarithm of the Minimum Angle of Resolution)0.9 to -0.3. All of the visual acuity and functional vision testing examinations mentioned above were performed by a single ophthalmologist. The outcomes were recorded as average of three post-operative measurments.
Best Corrected Contrast Sensitivity in Photopic Condition
时间窗: average data of post-operative 3rd week, 6th week, 12th week measurements
Contrast sensitivity testing was measured with spectacle correction for the target distance of three meters using a wall-mounted FACT sine-wave grating chart with nine levels of contrast (Stereo Optical Inc.)and five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd)) at 250 lux. The last correct grating seen for each spatial frequency is recorded and translated by the "EYEVIEW™ Functional Analysis Software" into a log contrast sensitivity unit. The outcomes were recorded as average of the three post-operative measurements. ( physiological range of contrast sensitivity: 1.5 cpd : 25\~82.5 ; 3 cpd: 30\~150 ; 6 cpd: 65 \~ 200 ; 12 cpd: 20 \~130 ; 18 cpd: 6.5 \~ 65 )
次要结局
- Corneal High-order Aberrations(pre-op & averate data of post-op 3rd, 6th, 12th week measurements)
- Total Ocular High-order Aberrations(average data of post-op 3rd, 6th, 12th week measurements)