A prospective, controlled randomized, comparative, single center, clinical study to evaluate performance and safety of implanted Capsular Tension Ring (CTR) and CTR delivery system.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 3
- 主要终点
- 1)Refraction - Refractive prediction error - Measured as subjective refraction. Both spherical and astigmatism shall be measured by using phoropter.
研究概览
简要总结
**Titleof Study:**A prospective,controlled randomized, comparative, singlecenter, clinical study to evaluate performance and safetyof implanted Capsular Tension Ring (CTR) and CTR delivery system.
Objectives:
Primary Objectives:
To evaluate the performance of Capsular Tension Ring(CTR) against controlled group (without CTR) to check clinical outcome ofrefractive prediction error.
SecondaryObjectives:
For Capsular Tension Ring:
· To evaluatethe performance of Capsular Tension Ring against controlled group (without CTR)to check clinical outcome of visual acuity.
· To evaluatesafety of Capsular Tension Ring implanted group and controlled group (withoutCTR).
ForDelivery System:
To check the safety and performance of two delivery systems for CTRimplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients older than 12 years
- •Normal fundus examination
- •Patients for whom phacoemulsification is required of cataract surgery
- •Patients with axial length >28 mm, or more than 3 months had passed since Pars plana vitrectomy (PPV)
- •Patients with weak zonules along with any of this following conditions Inadequate zonular support Patients with the pseudo-exfoliation syndrome Trauma causing zonular dialysis Phacodonesis
- •Patients who are eligible for phacoemulsification alone or with CTR implants
- •Patient willing to participate and sign informed consent forms.
- •Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
排除标准
- •1.Presence of a torn or compromised capsular bag or significant, progressive pseudoexfoliation 2.Patients with retinitis pigmentosa, trauma, other intraocular surgeries than PPV, or connective tissue disorders 3.Patients with chronic uveitis 4.Patients with progressive eye disease (e.g. diabetic retinopathy, uncontrolled glaucoma) 5.Patients with preoperative complications prior to cataract surgery (e.g. vitreous body prolapse, haemorrhage) 6.Patients with perforated or damaged capsules 7.Patients with zonular damage larger than 4 clock hours 8.Zonular rupture >90º 9.Pregnancy (as stated by patient) and lactation 10.Patients with concurrent participation in another drug or medical device clinical study.
结局指标
主要结局
1)Refraction - Refractive prediction error - Measured as subjective refraction. Both spherical and astigmatism shall be measured by using phoropter.
时间窗: Time Frame: Pre-operative, 90 Days Post- operative surgery
次要结局
- 1)Visual Acuity-UDVA - The visual acuity upto 90 ± 7 days post- operative surgery, measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Visual acuity measured by ETDRS chart.(2)Visual Acuity- BCDVA - The visual acuity upto 90 ± 7 days post- operative surgery, measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Visual acuity measured by ETDRS chart.)