NCT01191229已完成4 期
Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens AO
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Incision size
研究概览
简要总结
The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual correction of aphakia (replacing a removed lens in the eye) in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Key Inclusion Criteria for Part 1:
- •Age 18 or greater
- •Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
- •Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
- •Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
- •Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- •Preoperative corneal astigmatism of 1.5 D or less
- •Clear intraocular media other than cataract
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
- •Inclusion Criteria for Part 2
- •At least 18 years of age
- •Underwent bilateral implantation with Crystalens AO at least 6 months previously
- •Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
- •Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
- •Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- •Preoperative corneal astigmatism of 1.5 D or less
- •Clear intraocular media other than cataract
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
排除标准
- •Key Exclusion Criteria for Part 1:
- •Use of systemic or ocular medications that may affect vision
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- •Subjects with diabetes mellitus
- •Uncontrolled systemic or ocular disease
- •History of ocular trauma or prior ocular surgery
- •Amblyopia or strabismus
- •Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- •Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
- •Patients with forme fruste keratoconus or keratoconus
- •Subjects who may be expected to require retinal laser treatment or other surgical intervention
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- •Contact lens usage within 6 months for PMMA contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
- •Requiring an intraocular lens <15.0 or >26.0 diopters
- •Exclusion Criteria for Part 2
- •Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
- •Patients with forme fruste keratoconus or keratoconus
- •Subjects who may be expected to require retinal laser treatment or other surgical intervention
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- •Requiring an intraocular lens <15.0 or >26.0 diopters Exclusion Criteria for Part 2
- •Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
- •Patients with forme fruste keratoconus or keratoconus
- •Subjects who may be expected to require retinal laser treatment or other surgical intervention
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- •Requiring an intraocular lens <15.0 or >26.0 diopters
结局指标
主要结局
Incision size
时间窗: 1 year
Part 1 Only: The primary outcome measure is incision size at three points: Immediately after application of the keratome blade Post phacoemulsification Post Tecnis IOL implantation Target refraction vs. achieved Part 1 and 2: UCVA data at distance, intermediate, and near Near vision will be measured in mesopic and photopic conditions standardized with light meter BCVA at distance and near Enhancement rates Spectacle independence questionnaire and patient satisfaction Incidence of adverse events
次要结局
未报告次要终点
研究者
研究点 (2)
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