Comparative Analysis of the Visual Performance in Patients With Stable Keratoconus After Implantation of the Toric Implantable Collamer Lens (TICL).
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Visual acuity (UCVA,BCVA) by Snellen chart
研究概览
简要总结
To report on 4-year postoperative safety, efficacy, stability and predictability outcomes(to evaluate the visual, refractive, contrast sensitivity, defocus curve and aberrometric data preoperation, and compare with a similar postoperative outcomes) with the Toric Implantable Contact Lens (TICL) for Stable keratoconus. Investigators will study the four-year follow-up from this standardized, multi-center clinical investigation, support from clinical and optical viewpoints TICL implantation, in stable keratoconus.
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
- 25 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age (25-38).
- •Stable refraction was distinctive by 6 subjective refractions within ± 0.50 diopters(D) of spherical equivalent during 6 months after CXL.
- •best spectacle-corrected visual acuity (BCVA) of +0.4 LogMAR (20/40) or better, -clear central cornea.
- •normal anterior chamber depth at least 3 mm to endothelium .
- •intraocular pressure (IOP)<20 mm Hg and preoperative endothelial cell count related to age and the anterior chamber depth with regard to Food and Drug Administration recommendations.
- •Width of Angle greater than 30°, a pupil diameter of less than 6.25 mm.
排除标准
- •Patients with central corneal thickness of less than 450 μm.
- •endothelial cell count of less than 2,000 cells/mm2 .
- •anterior chamber depth of <3 mm from endothelium to anterior capsule .
- •Corneal opacification or scars, cataract, retinal detachment, glaucoma, retinopathy, macular degeneration, neuro ophthalmic diseases or ocular inflammation, history of keratitis (any form), peripheral marginal degeneration, previous corneal and/or intraocular surgeries, and autoimmune and/or connective tissue disease. The central corneal thickness limit of 450 μm would account for around 400 μm of remaining stromal thickness after removal of the epithelium, which is considered as the safety thickness for the residual stroma to avoid endothelial cell damage during the CXL procedure.
研究组 & 干预措施
Toric Implantable contact Lens
The Visian implantable collamer lens (Staar Surgical AG, Nidau, Switzerland), is a monoblock single-piece plate haptic lens made of collamer (an extremely hydrophilic and highly biocompatible flexible collagen copolymer with a refractive index of 1.452 that is permeable to oxygen and nutrients
干预措施: Toric Implantable collamer Lens (Device)
结局指标
主要结局
Visual acuity (UCVA,BCVA) by Snellen chart
时间窗: Up to 4 years after surgery
次要结局
- Refractive error by Auto Kerato-Refractometer(Until 4 years after surgery)
- Defocus curve by Phoropter(Up to 4 years after surgery)
- Patient satisfaction to measure the patients' subjective assessment of visual improvement by a validated questionnaire(up to 4 years after surgery)
- Contrast sensitivity by MediWorks C901 Acuity Chart (Shanghai MediWorks Precision Instruments Co, Ltd, Shanghai, China.(up to 4 years after surgery)
- Aberrometry by Ray Tracing(Up to 4 years after surgery)
研究者
Farideh Doroodgar
Clinical Professor
Shahid Beheshti University