Prospective, Multicenter,Randomized Clinical Investigation of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation to Treat High Myopia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Early Post-operative Intraocular Pressure
研究概览
简要总结
This study evaluates the safety and efficacy of a viscoelastic-free method for Implantable Collamer Lens(ICL) implantation to treat high myopia. The subjects undergo randomization of ICL implantation using the viscoelastic-free method on one eye and undergoing standard method on the other one. The post-operative data are collected for analysis.
详细描述
Implantable Collamer Lens(ICL) implantation has been proved to be an effective refractive option for surgical correction of high myopia. Currently, standard method utilizing the viscoelastic agent to fill and maintain the anterior chamber during the implantation, this requires an additional step to remove the viscoelastic agent at the end of the surgery and may cause the intraocular pressure spike in the early post-operative phase due to the incomplete removal of the viscoelastics. The new method is viscoelastic-free, which can be achieved by using balanced salt solution irrigation during the implantation.
This study is a prospective, randomized, paired-eye study to compare the safety and efficacy of the viscoelastic-free method with the standard method. Subjects enrolled in the study will be randomized to receive viscoelastic-free method on one eye and undergo standard method on the other one.The clinical outcomes of two groups will be assessed at several follow-ups: 2 hours, 1 day, 1 week, 1 month, 3 months and 6 months post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented stable refraction for at least 1 year(within 0.5D)
- •Best spectacle-corrected visual acuity (BCVA) of 20/40 or better
- •Clear central cornea
- •-0.5D to -18.0D of myopic refractive error
- •Normal anterior chamber depth at least 2.8 mm to endothelium
- •Endothelial cell density (ECD) more than 2000 cell/mm2
- •Pupil diameter smaller than 7.0 mm under mesopic condition
- •Discontinued 3 weeks for hard contact lens and 1 week for soft contact lens wear
排除标准
- •Preexisting ocular diseases or conditions other than myopia, evidence of progressive or acute ocular disease
- •Evidence of connective tissue disease or other systemic diseases that may confound the results of the study;
- •Narrow angle of anterior chamber
- •Pregnant, lactating, or planning to become pregnant during the course of the trial
研究组 & 干预措施
viscoelastic-assisted system
Eyes in this group will utilize the standard viscoelastic-assisted Implantation system during the surgery
干预措施: standard viscoelastic-assisted Implantation system (Device)
viscoelastic-free system
Eyes in this group will use viscoelastic-free implantation system during the surgery
干预措施: viscoelastic-free implantation system (Device)
结局指标
主要结局
Early Post-operative Intraocular Pressure
时间窗: 2 hours after surgery
Intraocular Pressure measured by non-contact tonometers
次要结局
- Duration of operation(at the time of the surgery)
- Corrected Visual Acuity (UCVA) at Distance(baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery)
- Vault measured by anterior segment OCT(2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery)
- Refractive error (by Phoropter)(baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery)
- Uncorrected Visual Acuity (UCVA) at Distance(baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery)
- Intraocular Pressure(baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery)
- Anterior chamber reaction (by a laser flare meter)(baseline, 2 hours, 1 day, 1 week after surgery)
- Complications of ICL implantation(up to 6 months after surgery)
- Endothelial Cell Density(baseline, 1 month, 3 months and 6 months after surgery)
研究者
A-Yong Yu
Director of the Cataract Clinical Center
Wenzhou Medical University