Evaluation of Visual Outcomes and Quality of Vision following Implantation of a New Enhanced Monofocal Intraocular Lens
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate distance, intermediate and near visual acuity after implantation of Vivinex Impress XY-IM100 (Hoya Surgicals) for age related cataracts.
研究概览
简要总结
TITLE:
Early Visual Outcomes and Quality of Vision following implantation of a New Enhanced Monofocal Intraocular Lens
PURPOSE:
To evaluate early visual outcomes, safety and efficacy of a new enhanced
monofocal intraocular lens over 3 months.
SETTING:
Nethradhama Super Speciality Eye hospital
METHODOLOGY:
This is a prospective, single centered, interventional study, in which Vivinex
Impress XY1-EM (Hoya Surgical Optics, Singapore) was implanted in 60 eyes.
Post operatively on day 15- and 3-months following tests were done. Uncorrected
(UDVA) and corrected distance visual acuity (CDVA), manifest sphere, cylinder
and Spherical Equivalent (SE), Contrast sensitivity testing (FACT), internal and
total aberrations assessment using ray tracing aberrometry, objective scatter index,
dilated examination for IOL position, binocular corrected defocus curve using
defocusing lenses from +3 to –3D and reading speed using Salzburg reading desk
(SRD) at preferred reading and intermediate distance were performed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 35.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Eyes with senile cataract of grades 1-4 Nuclear Sclerosis, Cortical cataracts, Posterior subcapsular cataract Corneal astigmatism equal to or less than 1D IOL power between +10D to +30D In the bag IOL implantation.
排除标准
- •Eyes with corneal astigmatism more than 1.0 D Hypermature/morgagnian/intumescent and brunescent cataracts more than NS 4 Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts less than 1500 Pupillary abnormalities History of glaucoma or intraocular inflammation Macular disease or retinopathy, neuro-ophthalmic diseases, active infections, previous ocular surgery of any kind, any other ocular pathology.
- •Intraoperative or postoperative complications.
结局指标
主要结局
To evaluate distance, intermediate and near visual acuity after implantation of Vivinex Impress XY-IM100 (Hoya Surgicals) for age related cataracts.
时间窗: Baseline, Post operative day 1, 15 and 3 months
次要结局
- To evaluate quality of vision by measuring contrast sensitivity, objective scatter index, spherical aberrations, and defocus curve.(post operative day 1, 15 and 3 months)
研究者
Dr Supriya Sriganesh
Nethradhama Super Speciality Eye Hospital