NL-OMON21890尚未招募不适用
Validation of the Dutch Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
Relationship between spectacle dependency, as assessed with PRSIQ-NL, and visual functioning, as assessed with Catquest-9SF-NL, after cataract surgery.0 个研究点目标入组 400 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Cataract patients: age of at least 18 years, diagnosis of cataract in both eyes, having consented to and is planned to undergo cataract surgery in both eyes, expected best-corrected distance Snellen decimal visual acuity of 0.7 or better in each eye, planned for implantation in both eyes of a a) non-toric monofocal IOL with target emmetropia, b) non-toxic monofocal IOL with target mild myopia, c) toric monofocal IOL with target emmetropia, d) non-toric enhanced far-focus IOL, e) extended depth of focus IOL with target emmetropia or monovision, f) trifocal IOL with target emmetropia, willing and able to participate in both preoperatieve and postoperative examination, and agreeing to sign the consent form.
- •Healthy subjects: age of at least 18 years, no ocular or visual complaints (other than using spectacles or contact lenses), no significant history of ocular disease (including cataract, corneal disease, glaucoma, and posterior segment eye disease), no history of ocular surgery (including cataract surgery and corneal refractive surgery), willing and able to participate in examinations, and agreeing to sign the consent form.
排除标准
- •Cataract patients: insufficient understanding of the Dutch language to comply with study procedures, best-corrected distance Snellen decimal visual acuity of <0.7 in either eye after cataract surgery, any comorbidity (other than cataract) that may significantly affect visual function, influence subjective ocular visual symptoms, or prolong visual recovery after surgery, such as significant macular degeneration, glaucoma, diabetic eye disease, ocular surface disease, corneal dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident, a history of ocular surgery (e.g., corneal refractive surgery), an increased risk of complicated cataract surgery, such as lens subluxation or (phaco)iridodonesis, brunescens cataract, rubra cataract, ingrains cataract, or posterior pole cataract, history of ocular trauma, and a complication, either perioperatively or postoperatively, that significantly affects vision and has not resolved before 3 months after surgery.
- •Healthy subjects: insufficient understanding of the Dutch language to comply with study procedures.
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