To assess the safety and efficacy of posterior chamber phakic intraocular lens (PCPIOL) in patients with high myopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aurolab
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- a) Uncorrected visual acuity
研究概览
简要总结
The most commonly used method to correct the refraction error is LASIK But LASIK cant be done for patients having irregular and thin corneas. For those with thin or abnormal corneas Keratoconus and dry eye, phakic IOL is an excellent alternative to laser eye surgery. A Phakic IOL is an innovative emerging technology with an optical design intended to correct widest range of myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (Cylinder power). ICL procedures are being used on highly nearsighted and farsighted patients who may not be candidates for the more common laser procedures such as LASI, LASEK and PRK.
Aurolab has developed zero aberration aspheric phakic foldable intraocular lens to correct low to high myopic refraction error in patients. This new technique is similar to cataract surgery, but the natural lens remains in place. So the eye’s natural focusing ability is preserved.
I
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Adults of > 21 years b) Stable refraction atleast for 1 year c) Myopia and Myopic astigmatism less than 1 D of corneal astigmatism d) Clear intraocular media e) Intraocular pressure of <20mmHg f) Anterior chamber depth of atleast 2.8 mm and angle<33 degree (from pentacam) g) Endothelial cell count >2500 cells/mm2 h) Normal posterior segment i) AS OCT (Open angles) j) Abnormal elevation and curvature maps not fit for corneal refractive surgery.
- •k) understand and willing to participate in the study for 2 years of follow up period l) No systemic illness.
排除标准
- •a) Participation in any other drug or device clinical trial within 90 days prior to enrolling in this study and/or during study participation b) corneal pathologic conditions like degenerations and dystrophies and keratoconus c) Evidence of any lens opacity or developing cataract, pseudoexfoliation or pigmentory dispersion d) History of glaucoma and uveitis e) Previous history of ocular diseases f) History of any intraocular or corneal surgery in either eye (including LASIK PRK LRI etc) g) Anterior chamber depth <2.8 mm and angle <33 degree h) Pregnancy and lactation.
结局指标
主要结局
a) Uncorrected visual acuity
时间窗: day 1 one month | three months | six months | 12 months | 18 months | 24 months
c) Intraocular Pressure
时间窗: day 1 one month | three months | six months | 12 months | 18 months | 24 months
b) Best corrected visual acuity
时间窗: day 1 one month | three months | six months | 12 months | 18 months | 24 months
d) Endothelial cell count
时间窗: day 1 one month | three months | six months | 12 months | 18 months | 24 months
e) Post operative inflammation
时间窗: day 1 one month | three months | six months | 12 months | 18 months | 24 months
次要结局
- visual acuity(Post operative complications)