Evaluation of Safety and visual Performance of Cast molded, Preloaded Hydrophobic Intraocular lenses (IOL) in age-related Cataract patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Aurolab
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- -Best Uncorrected Distance Visual Acuity
研究概览
简要总结
-The main aim of this study is to determine the safety and efficacy of Aurolabs Cast molded Preloaded Hydrophobic Intraocular lenses (IOL) in age related cataract patients
-Primary Objective will be Best uncorrected distance visual acuity and Secondary Objective will be Incidence of PCO formation and Glistening of IOL
-105 patients meeting the inclusion criteria will be enrolled in this study and written consent will be taken from all the patients
-Preoperative examination will include refraction, keratometry slitlamp biomicroscopy noncontact tonometry and detailed fundus examination
- Surgical procedure will be the same for all phacoemulsification with Cast molded IOL implantation
-Surgeon will record any intra operative complications
-Patients will be followed up on 1 day 1week 1 month 6 months and 1 year
-Postoperative examination will include Visual acuity Refraction non- contact tonometry Anterior segment and fundus evaluation by slit lamp examination
-Glistening and PCO assessment will be performed by slit lamp bio microscopy using high powered magnification and the same will be evaluated by MIYATA SCALE and EPCO respectively
-Subjects will be evaluated for occurrence of post-operative complications like Iritis Corneal edema Uveitis Rise in IOP Postop Endophthalmitis Postop CME PCO formation during each follow up
-The performance endpoints will be UCDVA BCDVA IOL stability and patients satisfaction
The safety endpoints will be occurrence and frequency of adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Senile cataract eligible for phaco emulsification cataract surgery 2 Clear intraocular media other than cataract 3 Age above 40 years 4 BCVA equal to less than 6/12 in the study eye 5 Pre operative corneal astigmatism less than one diopter 6 Able to read understand and provide informed consent.
排除标准
- •1 Uncontrolled Diabetic retinopathy or systemic hypertension or cardiac disorder 2 Pseudo exfoliation 3 Traumatic cataract 4 Small pupil 5 Any pre existing corneal pathologies or dry eyes 6 Post lasik or refractive surgeries 7 Uncontrolled glaucoma or on treatment for glaucoma in either eye 8 Preoperative retinal detachment or clinically significant retinal pathology in the operative eye 9 Congenital cataracts 10 Prior ocular surgery in the study eye.
结局指标
主要结局
-Best Uncorrected Distance Visual Acuity
时间窗: - 1 day | - 1 week | - 1 month | - 6 months | - 1 year
次要结局
- -Incidence of PCO formation(-Glistening of IOL)