NCT00960700终止不适用
Clinical Investigational Plan of the Rayner M-flex Multifocal Intraocular Lens (IOL) With Different Near Additions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Visual acuity at distance and near
研究概览
简要总结
A multi-centre non-randomized clinical investigation to assess multifocal visual outcomes using different near additions, for the treatment of aphakia after cataract removal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age-related cataract patients undergoing cataract surgery where the cataractous lens has been removed by phacoemulsification, with circular tear capsulotomy, leaving the posterior capsule intact
- •Patients requiring primary IOL implantation
- •Patients with a potential corrected visual acuity of 20/40 or better on clinical assessment
- •Patients with normal anterior segments - apart from cataracts
- •Subjects with clear intraocular media other than cataract
排除标准
- •Pre-existing pathology or physiology, which may be aggravated by the implant, or may render the implant ineffective and that could potentially cause future acuity losses to a level of 0.5 or 20/40 or worse in either eye. This includes the following:
- •Microphthalmia
- •Corneal decompensation or Endothelial Insufficiency
- •Pseudo exfoliation
- •High myopia
- •Pars planitis
- •Patient with greater than 1 dioptre of pre-operative corneal astigmatism
- •Subjects who are expected to require retinal laser treatment
- •Previous intraocular and/or corneal surgery
- •History of uveitis, glaucoma, proliferative diabetic retinopathy or IDDM, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better
- •Operative complications of posterior capsular rupture, zonular dehiscence, incomplete continuous curvilinear capsulorhexis, severe iris /corneal trauma and inability to achieve secure placement in the designated location
- •Subjects using a systemic medication that is known to cause ocular side effects
- •Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days
- •Subjects who have only one eye with potentially good vision
- •Patients who are not willing to cooperate in the 6-months follow-up period
- •Children under the age of 18 years
结局指标
主要结局
Visual acuity at distance and near
时间窗: 1 year
次要结局
- Range of clear vision(1 year)
- Reading speed(1 year)
- Cntrast sensitivity(1 year)
研究者
研究点 (2)
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