A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic Intraocular Lens
概览
- 阶段
- 不适用
- 干预措施
- EDOF ICL
- 疾病 / 适应症
- Presbyopia
- 发起方
- Staar Surgical Company
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
This study will evaluate the clinical performance of a phakic intraocular lens (IOL) for the improvement of Uncorrected Near Visual Acuity (UCNVA) in subjects who require between +1.00 and +2.50 Reading Add.
详细描述
This is a prospective, open-labeled, multi-site evaluation of clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric (EDOF) Optic \[EDOF ICL\] for the improvement of UCNVA in subjects who require between +1.00 and +2.50 Reading Add. Approximately 48 subjects who meet all eligibility criteria will undergo EDOF ICL implantation in both eyes. All eyes will be followed for 6 months after surgery. The first eye implanted with the study lens and the appropriate time for fellow eye implantation will be determined by the medical judgement of the Investigator. All eyes will be analyzed for safety and performance. The primary performance endpoint is defined as achievement of monocular UCNVA of Snellen equivalent 20/40 or better at 40 cm at 6 months after implantation in equal to or greater than 75% of implanted eyes.
研究者
入排标准
入选标准
- •Must be able to read, understand and provide written informed consent,
- •Willing and able to comply with all treatment and follow-up study related procedures,
- •40 - 60 years of age at time of surgery if require spherical lens powers from -0.50 D to -18.00 D,
- •35 - 45 years of age at time of surgery if require a spherical lens power from 0.0 D to +3.00 D,
- •Preoperative refraction fully correctable with available lens powers, with ≤ 0.75 D preoperative refractive and residual cylinder,
- •\< 0.75 D spherical equivalent difference between cycloplegic and manifest refractions,
- •Stable correction (± 0.50 D) as determined by manifest refraction spherical equivalent (MRSE),
- •Best Corrected Distance Visual Acuity 20/20 or better in both eyes,
- •Requires +1.00 D to +2.50 D reading add,
- •Anterior chamber depth (ACD) ≥ 2.8 mm if require spherical lens powers from -0.50 D to -18.00 D,
排除标准
- •Participation in a clinical trial within 30 days prior to entry into this study and/or during the period of study participation,
- •Previous intraocular or corneal surgery in either eye, including refractive surgery,
- •Progressive sight threatening disease or other previous or current ocular conditions, other than myopia in either eye,
- •Low/abnormal corneal endothelial cell density,
- •Presence of active or history of chronic inflammation in either eye,
- •Clinically significant irregular astigmatism in either eye,
- •Serious, acute, chronic or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion,
- •Use of topical steroids at time of implantation,
- •Systemic or topical medication, other than prescribed study medications that may confound the outcome or increase the risk to the subject,
- •Allergy to anesthetics or other postoperative medications required in this study,
研究组 & 干预措施
Study population
EDOF ICL implanted into both eyes of eligible subjects.
干预措施: EDOF ICL
结局指标
主要结局
Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation
时间窗: 6 months
Number of Eyes with Monocular Uncorrected Near Visual Acuity of 20/40 or better at 40 cm six months after implantation
次要结局
- Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation(Baseline and 3 months)
- Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation(Baseline and 1 month)
- Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation(Baseline and 1 month)
- Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation(Baseline and 1 month)
- Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 3 Months Post Implantation(Baseline and 3 months)
- Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation(Baseline and 6 months)
- Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation(Baseline and 1 month)
- Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 1 Month After Implantation(1 month)
- Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation(3 months)
- Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation(Baseline and 3 months)
- Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation(Baseline and 6 months)
- Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation(Baseline and 3 months)
- Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation(Baseline and 6 months)
- Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 1 Month Post Implantation(Baseline and 1 month)
- Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 6 Months Post Implantation(Baseline and 6 months)
- Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation(Baseline and 3 months)
- Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation(Baseline and 6 months)