A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 28
- 主要终点
- Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines
研究概览
简要总结
The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.
详细描述
The clinical investigation of the PresView™ Scleral Implant (PSI) is a prospective multicenter clinical trial in which a total of 330 subjects were enrolled and implanted with the PSI and followed for a period of 24 months at up to 14 clinical sites.
An additional randomized sub-study was performed on 48 subjects with the PSI Second Generation PresView™(SGP) implant, model number SGP-046. A 2:1 randomization was used to determine the 32 subjects assigned to be implanted and the 16 subjects assigned to the observation/deferred implantation control arm. Subjects randomized to the deferred implantation control arm were eligible to receive the PSI after completion of the 6 months of observation in the study.
All subjects interested in participating in the study were screened for eligibility, and informed consent was obtained from those who meet the inclusion/exclusion criteria. Eligible subjects were examined preoperatively to obtain a medical history and baseline ocular data.
Effectiveness: The following tests/measurements used to evaluate the effectiveness of the PSI procedure will be included in the study protocol:
- Near visual acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)
- Reading acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be between 50-60 years old
- •Subject must have a best corrected distance visual acuity of 20/20 or better
- •Subject must have SLOAN distance corrected near visual acuity @ 40cm in the operative eye/eyes of 20/50 to 20/100 (inclusive).
- •Subject should have a manifest distance spherical equivalent refractive correction in the operative eye/eyes of from -0.50 to +0.75 diopters with no more than 1.00 diopter of astigmatism and should require at least a +1.50 diopter add. The distance manifest refraction spherical equivalent and the distance cycloplegic refraction spherical equivalent must be within 0.50 diopters of each other.
- •Subject must be phakic in the study eye
- •Subject must be mentally competent to understand and comply with the requirements of the study.
- •Subject must be able to provide written informed consent.
排除标准
- •Chronic uveitis or other recurrent anterior or posterior segment inflammation in either eye.
- •Scleral thickness less than 530 μm in the operative eye/eyes.
- •Any previous eye surgeries including cataract, LASIK, or Muscle surgery
- •Any history of prior extraocular muscle surgery, specifically the recti or oblique muscles.
- •Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.
- •Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases
- •Allergic to any medications used in the study.
- •The patient may not have participated in a device clinical study for the operative eye within the last 3 months and may not have been implanted with PSI devices in this or any other study.
研究组 & 干预措施
Implantation-Non Randomized
Subjects are not participants in the randomized sub-study. PresView Scleral Implants surgical placed in the eye(s) after enrollment and meeting inclusion/exclusion criteria.
干预措施: PresVIEW Scleral Implants (Device)
Implantation-Randomized
Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. PresView Scleral Implants surgical placed in the eye(s)Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.
干预措施: PresVIEW Scleral Implants (Device)
Deferred Implantation-Randomized
Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have PresView Scleral Implants surgically placed in the eye(s) and become part of the overall study experimental group.
结局指标
主要结局
Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines
时间窗: From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.
Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.
次要结局
- Presence of Significant Safety Events (SAEs).(From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.)