Premium Monovision Versus Bilateral Myopic Monovision, Hybrid Monovision and Bilateral Trifocal Implantation. A Comparative Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Binocular uncorrected distant visual acuity [bUD-VA]
研究概览
简要总结
Primary objective of this study was to compare the efficacy of premium monovision with Restor and Panoptix, against other prevalent monovision techniques and against bilateral Panoptix implantation in a sample of patients following lens-extraction surgery.
详细描述
Four study groups were formed according to the procedure and the intraocular lens technology that was used: a) Monovision Group (MoG), b) Multifocal Lens Group (MfG), c) Hybrid Monovision Group (HmG), and, d) Premium Monovision Group (PmG). Patients who have undergone one of the above categories of presbyopia correction surgery were selected to compare the effectiveness of these techniques by evaluating the uncorrected near, intermediate and distant visual acuity as well as the degree of subjective patient satisfaction, contrast sensitivity, dysphotopsia symptoms and spectacle independence .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale
排除标准
- •Manifest astigmatism > 1.00 diopters
- •Reports of headaches and/or eyestrain associated with visual activities
- •Positive, pathologic ocular cover test (near & distant) and / or the Mallett's disparity test (near & distant) and the double Maddox rod test
- •Endothelial cell count less than 1900/mm2
- •intraocular pressure-lowering medications
- •Former incisional surgery
- •Former diagnosis of corneal disease
- •Former diagnosis of fundus disease
- •Autoimmune diseases
- •Mental diseases
结局指标
主要结局
Binocular uncorrected distant visual acuity [bUD-VA]
时间窗: through study completion, an average of 2.5years
bUD-VA is obtained using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance. This parameter is obtained six months following the operation of the second eye.
Binocular uncorrected intermediate reading acuity (at 60cm) [bUI-RA)]
时间窗: through study completion, an average of 2.5years
bUI-RA is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.
binocular uncorrected near reading acuity (at 40cm) [bUN-RA]
时间窗: through study completion, an average of 2.5years
bUN-RA is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.
binocular uncorrected intermediate critical print size (at 60cm) [bUI-CPS]
时间窗: through study completion, an average of 2.5years
bUI-CPS is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.
binocular uncorrected near critical print size (at 40cm )[bUN-CPS]
时间窗: through study completion, an average of 2.5years
bUN-CPS is obtained using the DDART reading test, which is based on the Greek version of MNREAD. This parameter is obtained six months following the operation of the second eye.
次要结局
- Dysphotopsia symptoms(through study completion, an average of 2.5years)
- Subjective satisfaction using Visual Function Index (VF-14 instrument) (total score, VF14-NV score & VF14-DV score)(through study completion, an average of 2.5years)
- Contrast sensitivity(through study completion, an average of 2.5years)
- Spectacle independence(through study completion, an average of 2.5years)
研究者
Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Democritus University of Thrace