A Prospective Study to Assess the Clinical and Refractive Outcomes of the Use of a Femtosecond Laser on an Implanted Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Primary Endpoint - Change in mean manifest refraction spherical equivalent ("MRSE") (post- versus pre-treatment)
研究概览
简要总结
This is a prospective non-randomized patient controlled single center study which is designed to evaluate the clinical outcomes of the treatment of an implanted intraocular lens using a low-energy femtosecond laser for refractive correction.
详细描述
The purpose of this research study is to evaluate the safety and efficacy of the treatment of an implanted intraocular lens with a device. The device employs a generic femtosecond laser used in numerous other ophthalmic procedures. The device uses low levels of energy from the femtosecond laser to correct spherical, cylindrical and sphero-cylindrical refractive error existing in an implanted intraocular lens. The refractive correction is effected through the treatment, which is employed at least 30 days after cataract surgery.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand study requirements, follow study instructions and to return for required study follow-up visits as confirmed by provision of written informed consent.
- •Subject has undergone cataract surgery and has had an AMO ZCB00/PCB00/AAB00 in at least one eye (only one eye will be treated).
- •Subject has post-operative refractive error of one diopter or more of spherical, cylinder or sphero-cylinder difference from desired refraction.
- •20/40 or better BCDVA at 4m.
排除标准
- •Subject not able to complete the informed consent form.
- •Astigmatism greater than 3 diopter.
- •Spherical diopter error of greater than 4 diopters.
- •Combined spherical and cylinder diopter error of greater than 5 diopters.
- •Clinically significant corneal abnormalities including corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy), inflammation, keratitis, keratoconjunctivitis, keratouveitis, keratopathy, keratectasia or edema per the Investigator's expert medical opinion.
- •Previous corneal transplant.
- •Previous refractive surgery or proposed refractive surgery procedures throughout the entire duration of the subject's participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions).
- •History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that the Investigator judges could confound outcomes, including but not limited to background diabetic retinopathy, diabetic macular edema or proliferative diabetic retinopathy, macular degeneration.
- •History of or current anterior or posterior segment inflammation of any etiology, or any disease producing an inflammatory reaction in the eye (e.g. iritis or uveitis).
- •Optic nerve atrophy.
- •Iris neovascularization.
- •Subjects with diagnosed degenerative eye disorders (e.g. macular degeneration or other retinal disorders).
- •Any subject currently participating in another investigational drug or device study.
研究组 & 干预措施
Application of Perfector laser treatment
Active treatment arm
干预措施: Device (Other)
结局指标
主要结局
Primary Endpoint - Change in mean manifest refraction spherical equivalent ("MRSE") (post- versus pre-treatment)
时间窗: Between pre-treatment and 1 week post-treatment.
Change in mean manifest refraction spherical equivalent ("MRSE") post-treatment at 7-day visit versus pre-treatment.
Safety Endpoint - Primary Device Related Adverse Events (post- versus pre-treatment)
时间窗: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
Demonstrate that mesopic contrast sensitivity (with and without glare) post-treatment (at 7, 30 and 90-day follow up visits) is non-inferior to pre-treatment as measured by CTS contrast sensitivity (NI margin of 0.15 log units).
Safety Endpoint - Primary Device Related Adverse Events (post- versus pre-treatment)
时间窗: Between pre-treatment and 1 month and 3 months post-treatment.
Color vision discrimination compared between pre-op and post-op at 90-day visit (measured by the FM 100 Hue test) comparison of visual disturbances between pre-treatment and post-treatment (at 30 and 90 day-day follow up) assessed via Quality of Vision (QoV) questionnaire.
次要结局
- Secondary Endpoint - Demonstrate Best Corrected Distance Visual Acuity (BCDVA) (post- versus pre-treatment)(Between pre-treatment and 3 months post-treatment.)
- Secondary Endpoint - Comparison of manifest refraction spherical equivalent (MRSE) (post- versus pre-treatment)(Between pre-treatment and 1 week, 1 month and 3 months post-treatment.)
- Secondary Endpoint - Manifest refraction spherical equivalent (MRSE) stability (between any two follow up visits)(Between pre-treatment and 1 week, 1 month and 3 months post-treatment.)