Rotational Stability of V4C Toric Implantable Contact Lenses After On Axis Implantation Measured With OPD Scan 3
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Visual outcome
研究概览
简要总结
The recently introduced toric V4c toric ICL (STAAR Surgical Company, Monrovia, CA, USA) has been designed with a 360-µm central hole to allow aqueous humor to flow without the need for an iridotomy. As far as the investigators certain, there have been not well-established prospective studies on the role of the V4c toric ICL for myopic astigmatism correction. Therefore, the present study aimed to investigate the clinical outcomes and rotational stability and to analyze factors that influence the rotational stability in V4c toric ICL implanted eyes prospectively.
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
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-45 years
- •Presence of myopia with a manifest refraction spherical equivalent between -5.00 and -20.00 diopters (D)
- •Astigmatism between -0.75 and -5.00 D
排除标准
- •Previous ocular or intraocular surgery (other than ICL implant)
- •Anterior chamber depth from the endothelium < 2.8 mm
- •Corneal endothelial cell density < 2000 cells/mm2
- •Evidence of acute or chronic corneal infection, corneal inflammation
- •Glaucoma, amblyopia, retinal detachment, diabetic retinopathy, macular degeneration, or neuro-ophthalmic disease
研究组 & 干预措施
V4c toric ICL implantation Group
V4c toric ICL implantation Group
干预措施: V4c toric ICL implantation surgery (Procedure)
结局指标
主要结局
Visual outcome
时间窗: 6 months after the surgery
Evaluation of logarithm of the minimum angle of resolution (logMAR) uncorrected distance visual acuity (UDVA) and CDVA, manifest refraction, autorefractor-keratometer (ARK-530A; Nidek Co., Ltd.). The change of astigmatism was analyzed by the Alpins method.
Refractive outcome
时间窗: 6 months after the surgery
Evaluation of logarithm of the minimum angle of resolution (logMAR) uncorrected distance visual acuity (UDVA) and CDVA, manifest refraction, autorefractor-keratometer (ARK-530A; Nidek Co., Ltd.). The change of astigmatism was analyzed by the Alpins method.
次要结局
- Rotational stability(6 months after the surgery)
- Rotational stability(immediately after the surgery)
- Rotational stability(3 months after the surgery)