Early Feasibility Study to Evaluate the Safety and Effectiveness of the Intraoperative Pseudophakic Capsular Lens Magnifier for Age-Related Macular Degeneration (IOPCL AMD-MAG) for Secondary Implantation in the Capsular Bag to Improve Near Vision in Subjects With Age-Related Macular Degeneration After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Tilt of the PCIOL and IOPCL MAG Complex
研究概览
简要总结
This early feasibility study aims to improve near vision in subjects 55 years or older who have a clinical diagnosis of Age-Related Macular Degeneration. Subjects must have previously been implanted with either the Alcon Model SN60WF or Model SA60AT intraocular lens at least 6-months prior to receiving the IOPCL (intraocular pseudophakic capsular lens). Subject will be followed for a period of 12-months.
详细描述
This will be a 12-month study, in which a maximum of 10 pseudophakic subjects from up to three clinical sites with a diagnosis of age-related macular degeneration will be enrolled. The IOPCL MAG (intraocular pseudophakic capsular lens magnifier) consists of a 4.5mm diameter optic. The IOPCL MAG is centered above the existing intraocular lens. The IOPCL MAG is designed to improve near vision of the AMD subject by providing magnification of 10 diopters in the central 1.8mm zone of the lens optic.
The primary objective of this study is to determine the stability of the IOPCL-AMD-MAG to successfully adhere to a pseudophakic intraocular lens (PCIOL) without slippage or rotation.
The secondary objective of this study is to determine if the IOPCL-AMD-MAG can improve uncorrected near vision in subjects previously implanted with the Alcon Models SN60WF or SA60AT.
Outcome simulation testing will be performed prior to the subject receiving the IOPCL. To qualify for the study the subject must demonstrate an improvement in uncorrected near visual acuity of 10 letters over baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 55 years or older.
- •Subjects who have already had cataract surgery with an Alcon SN60WF or SA60AT monofocal intraocular lens with a lens power between 17.0 diopters and 24.0 diopters clearly evidenced by photographic documentation by one of the following:
- •patient medical record
- •clinic chart with labeling attached
- •surgical record with labeling attached, or
- •patient identification card with make, model and serial number.
- •Subjects who have already had cataract surgery at least 6 months from the planned date of the IOPCL surgery.
- •Subjects who have had a Nd: YAG capsulotomy at least 1 month prior to the planned date of the IOPCL surgery.
- •Subjects with non-neovascular dry AMD meeting the following criteria:
- •No change in Amsler Grid test within the past 12 months
- •No subretinal fluid or macular hemorrhage confirmed by optical coherence tomography (OCT) imaging.
- •No fundoscopic changes within the past 12 months (i.e., changes in retinal pigment epithelium).
- •Subjects with best corrected distance visual acuity from 20/80 to 20/
- •Subjects with a preoperative manifest refraction spherical equivalent (MRSE) of +1.0D to -1.0D.
- •Subjects with ≤1.0D of corneal cylinder determined by keratometry readings.
- •Subjects who are unsatisfied with their current near vision correction provided by either spectacles or external magnifier.
- •Subjects who demonstrate at least 10 letters of near visual acuity improvement with the simulation/tolerance test (using manifest refraction with +7.0D add) compared to conventional near vision testing (using manifest refraction with +3.0D add).
- •Subjects with a minimum endothelial cell count of 1800 cells/mm
- •Subjects willing to abstain from pursuing any other surgical vision-correcting procedures for the duration of the study.
- •Subjects who are willing and able to complete all required postoperative visits.
- •Subjects who are able to comprehend and sign a statement of informed consent.
排除标准
- •Subjects who have already had cataract surgery with a toric or multifocal or accommodating Intraocular Lens.
- •Subjects who have already had cataract surgery with an Alcon SN60WF or SA60AT monofocal intraocular lens with a power below 17.0 diopters and greater than 24.0 diopters.
- •Subjects with neovascular (wet) AMD.
- •Subjects who have not had an Nd: YAG capsulotomy.
- •Subjects who were treated with an IOL off-label.
- •Subjects who have more than 1.0D of corneal cylinder determined by Keratometry readings.
- •Subjects whose continuous curvilinear capsulorhexis was less than 5mm or more than 6.0 mm in size at the time of IOL surgery.
- •Subjects who had cataract surgery less than 6 months from the planned date of the IOPCL surgery.
- •Subjects with anterior capsule fibrosis and phimosis that in the opinion of the investigator may confound the outcome or increase the risk to the subject.
- •Subjects who do not gain at least 10 letters of near visual acuity with the simulation/tolerance testing (using manifest refraction with +7.0D add) compared to conventional near vision testing (using manifest refraction with +3.0D add).
- •Subjects with a concomitant retinal or choroidal disorder other than AMD.
- •Subjects with any corneal abnormality, other than regular corneal astigmatism that in the opinion of the investigator would confound the outcome(s) of the study.
- •Subjects with clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy).
- •Subjects with microphthalmos.
- •Subjects with a previous retinal detachment.
- •Subjects with a recurrent severe anterior or posterior segment inflammation of unknown etiology.
- •Subjects with iris neovascularization.
- •Subjects with glaucoma.
- •Subjects with advanced visual field defects (e.g., central large scotoma where magnification would not help).
- •Subjects with a fundus not visible.
- •Subjects with aniridia.
- •Subjects with advanced optic nerve atrophy.
- •Subjects with damaged or incomplete zonules.
- •Subjects with a known history of pseudoexfoliation.
- •Subjects with acute, chronic or uncontrolled systemic or ocular disease that in the opinion of the investigator would increase the operative risk or confound the outcome(s) of the study.
- •Subjects with medications that, in the opinion of the investigator, may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax)) or other medications with similar side effects (floppy iris syndrome).
- •Subjects with cognitive impairment that may interfere with the ability to understand the potentially complex considerations underlying an informed decision on trial participation and/or interfere with the ability to neuro-adapt to this device in the postoperative period.
结局指标
主要结局
Tilt of the PCIOL and IOPCL MAG Complex
时间窗: 12 Months
Measuring postoperative tilt of the PCIOL and IOPCL MAG complex. Tilt was defined as less than or equal to 10 degrees.
IOPCL MAG Decentration
时间窗: 12 Months
Measures the decentration of the IOPCL MAG against the PCIOL. Decentration was defined as the horizontal and vertical distances greater than or equal to 0.25mm or less than or equal to 0.75mm.
Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 75% Achieving ≥ 10 Letters)
时间窗: 12 Months
Proportion of eyes (≥ 75%) able to achieve improvement of 10 letters or more of uncorrected near visual acuity (at 14 cm) at 12 months from baseline
次要结局
- Uncorrected Near Visual Acuity at 14cm Change From Baseline (Letters) (≥ 50% Achieving ≥ 20 Letters)(12 months)
- Postoperative Uncorrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 75% Achieving ≥ 10 Letters)(12 months)
- Postoperative Uncorrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 50% Achieving ≥ 20 Letters)(12 months)
- Postoperative Best Corrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 75% Achieving ≥ 10 Letters)(12 months)
- Postoperative Best Corrected Near Visual Acuity at 14cm Compared to Preoperative Best Corrected Near Visual Acuity at 30cm With +3.0D Add (≥ 50% Achieving ≥ 20 Letters)(12 months)