Clinical And visual outcomes following bilateral implantation of trifocal intraocular lenses with asymmetric light distribution.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Monocular Uncorrected Distance Visual Acuity(UDVA) and Best Corrected Distance Visual Acuity (CDVA) using ETDRS chart at 4 meters
研究概览
简要总结
This is an interventional study assessing the visual and clinical outcomes of bilateral implantation of trifocal intraocular lenses with asymmetric light distribution. A total of 60 eyes from 30 patients fulfilling the inclusion and exclusion criteria will be included in the study with their demographic data. Patients who underwent bilateral cataract surgery with in the bag implantation of Trifocal Intraocular lens(IOL). Biometry will be performed using the Barrett’s formula (Barrett’s formula to be used with total keratometry (TK) implemented in the IOL Master 700). We will be assessing patients distant visual acuity, intermediate visual acuity and near vision. Patients quality of vision will be tested by defcous curve, SRD, iTrace, HDA, patient satsifaction score.
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
- 21.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Bilateral implantation (second eye surgery within two weeks from the first eye surgery.
- •Age more than 21 Years Cataractous eyes with no comorbidity Regular corneal topography and corneal astigmatism Patient desiring spectacle independence and having realistic expectations.
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures Signed informed consent.
排除标准
- •Active ocular disease in the operative eye Subjects with any systemic disease that could increase operative risk or confound the outcome Pregnant or lactating or planning a pregnancy at the time of enrolment Any patient who is taking part in another study involving ocular surgery Significant irregular corneal astigmatism- Keratoconus/ post refractive surgery/ post LASIK ectasia Pupil abnormalities.
结局指标
主要结局
Monocular Uncorrected Distance Visual Acuity(UDVA) and Best Corrected Distance Visual Acuity (CDVA) using ETDRS chart at 4 meters
时间窗: Post op day 1, 2 weeks, 3 Months Follow-up
Monocular and Binocular Uncorrected(UIVA)and distance corrected Intermediate Visual Acuity (DCIVA) using ETDRS charts at 40, 66 and 80 cm
时间窗: Post op day 1, 2 weeks, 3 Months Follow-up
Manifest refraction (Sphere, Cylinder, Spherical Equivalent)
时间窗: Post op day 1, 2 weeks, 3 Months Follow-up
Binocular Uncorrected near (UNVA) and distance corrected near visual Acuity (DCIVA) using ETDRS charts.
时间窗: Post op day 1, 2 weeks, 3 Months Follow-up
次要结局
- Binocular corrected defocus curve using defocusing lenses of -3.0D to +3D(Reading Speeds using Salzburg Reading Desk at preferred reading and intermediate distance)
研究者
Dr Supriya Sri Ganesh
Nethradhama Superspeciality Eye Hospital