A PROSPECTIVE,COMPARATIVE RANDOMISED CLINICAL STUDY TO EVALUATE THE SAFETY,EFFICACY AND REFRACTIVE OUTCOME OF TWO DIFFERENT TORIC IOLS IMPLANTED INTO PATIENTS WITH CATARACT AND CORNEAL ASTIGMATISM
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1.Rotational Stability,
研究概览
简要总结
It is a observational prospective comparative randomised clinical study to evaluate the safety efficacy and refractive outcome of two different TORIC IOLs implanted into patients with cataract and corneal astigmatism.
Total of 140 eyes are to be considered in the study with 70 eyes in each group where EYECRYL (BIOTECH ) and TECNIS TORIC implanted into patients .
Patients are recruited according to the inclusion and exclusion criteria mentioned in the study .Enrollment for 9 months and follow up for 6 months
Outcomes of Rotational stability, Refraction, Spherical Equivalence,Intra Ocular Pressure,Change in Endothelial cell count are summarized and compared using statistics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1Unilateral 2Adult patient 3Best corrected visual acuity projected to be 0.2 logMAR or lower 4Calculated IOL power is within the range of the investigational IOL 5Stability of the cornea has been demonstrated by keratometry 6Expected dilated pupil size at least large enough to visualize the axis markings 7Corneal cylindrical error within the range defined in the clinical investigation plan 8Patient must have preoperative regular corneal astigmatism from 0.5 to 4.50 D as per corneal topography or keratometry 9Patients who have and will attend all follow-up appointments 10Patients must sign and be given a copy of the written Informed Consent form.
排除标准
- •1Preoperative ocular pathology 2Presence of irregular corneal astigmatism 3Ocular co-morbidities affecting visual outcome 4Previous intra ocular or corneal surgery 5Traumatic cataract 6Corneal Opacities 7Ophthalmic diseases such as pseudoexfoliation, glaucoma, traumatic cataract corneal scars and other co-morbidity that could affect capsule bag stability 8Pre-existing corneal astigmatism lesser than 0.75 D 9Pre-existing retinal disease 10Pregnant & Lactating women 11Concurrent participation in another drug or device investigation.
结局指标
主要结局
1.Rotational Stability,
时间窗: Pre operatively, day 1,day 15,1,3 and 6 Months.
2.Corrected and Uncorrected Visual Acuity
时间窗: Pre operatively, day 1,day 15,1,3 and 6 Months.
3.Refraction and Refractive Astigmatism
时间窗: Pre operatively, day 1,day 15,1,3 and 6 Months.
4.Spherical Equivalence
时间窗: Pre operatively, day 1,day 15,1,3 and 6 Months.
5.Introcular pressure
时间窗: Pre operatively, day 1,day 15,1,3 and 6 Months.
6.Change in Endothelial Cell count
时间窗: Pre operatively, day 1,day 15,1,3 and 6 Months.
次要结局
- Secondary Surgery due to early onset of PCO(3 & 6 Months post surgery)