Comparison of visual outcomes, predicted vault and rotational stability of two Toric phakic IOLs
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the predicted vault and rotational stability between the EVO TICL versus the Eyecryl phakic toric IOL in correcting myopic astigmatism
研究概览
简要总结
Pre operative:
Patients satisfying the inclusion and exclusion criteria will undergo :Visual acuity assessment (Autorefractometer, subjective and cycloplegic refraction with tropicamide with phenylephrine).Intraocular pressure (IOP) recording by non-contact tonometry (Nidek Non-contact Tonometer NT-510).Detailed Slit lamp examination for anterior segment and posterior segment evaluation.Detailed indirect ophthalmoscopy for fundus examination
Tomography with Pentacam + MS39.Keratometry with Autorefractokeratometer (TOPCON RM 8900).Corneal thickness measurement by ultrasound Pachymetry.White to white measurement by Pentacam, AS OCT (MS 39) and digital callipers.Anterior Chamber Depth( ACD) measurement with Pentacam and AS OCT (MS 39).AC OCT and MS 39 for angle to angle measurement and lens rise.ICL power calculation using calculator provided by the manufacturer.
Post operative examinations:
Monitored for 2 hours after the surgery and IOP is checked every 30 minutes using an iCare tonometer to make sure the IOP is within normal limits. Following tests will be performed on day 1, 2 weeks, 3 months and 6 months.Uncorrected visual acuity (day 1, 2weeks, 3 months, 6 months).Corrected visual acuity (day 1, 2weeks, 3 months, 6 months). Subjective Refraction (day 1, 2weeks, 3 months). Intraocular pressure( day 1, 2 weeks, 3 months, 6 months). Slit lamp examination for clinical vault and angle (day 1,2 weeks, 3 months and 6 months).Position of the toric phakic IOL by dilated slit lamp examination (2 weeks, 3 months and 6 months. Dynamic Vault angle and height measurements using MS-39 (2 weeks, 3 months and 6 months).HDA (2weeks, 3 months and 6 months).iTrace for total higher order aberrations (2weeks, 3 months and 6 months). CSV 1000 for contrast sensitivity (2 weeks and 3 months)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with myopic astigmatism motivated to undergo correction who are less than 40 years of age Best corrected Visual acuityof 20/40 or better.
- •Healthy tear film and ocular surface Anterior chamber depth more than or equal to 2.8mm.
- •Endothelial cell count more than 2000 cells/mm
- •Absence of corneal ectatic diseases, corneal scars, absence of retinal pathologies.
排除标准
- •Corneal ectatic diseases, corneal scars, retinal pathologies Active ocular disease in the operating eye such as uveitis, glaucoma, diabetic retinopathy and corneal disorders including scars, opacities, and degenerations Progressive or unstable myopia and/or astigmatism.
- •Previous ocular surgery.
- •Dysfunctional lens syndrome, any evidence of cataract.
- •Anterior chamber depth less than 2.8mm.
- •Endothelial cell counts less than 2000 cells/mm2.
结局指标
主要结局
To compare the predicted vault and rotational stability between the EVO TICL versus the Eyecryl phakic toric IOL in correcting myopic astigmatism
时间窗: day 1, 2 weeks, 3 months and 6 months
次要结局
- To compare the Visual and refractive outcomes between the EVO TICL and the Eyecryl phakic toric IOL(day 1, 2 weeks, 3 months and 6 months)
研究者
Dr Sri Ganesh
Nethradhama Super Speciality Eye Hospital