Comparative Study of Premium Monovision and Bilateral Implantation of Trifocal Diffractive Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Binocular uncorrected intermediate reading acuity (bUIRA)
研究概览
简要总结
Primary objective of this study is to compare two presbyopia correction surgical techniques, specificaly premium monovision, in which the dominant eye is corrected with an extended depth of field intraocular lens and the non-dominant eye with a trifocal diffractive intraocular lens, and the bilateral implantation of trifocal diffractive intraocular lenses.
详细描述
Two study groups will be formed. The first group will include patients who undergone premium monovision and the second will include patients who undergone bilateral implantation of trifocal diffractive intraocular lenses. Patients who have undergone one of the aforementioned categories of presbyopia correction surgery will be selected in order to compare the effectiveness of these techniques by evaluating uncorrected near, intermediate and distant visual acuity, uncorrected Critical Print Size (CPS) in near and intermediate distance, dysphotopic phenomena (glare, halos) through a 4-level severity scale by patients, contrast sensitivity, the need of use glasses for all distances or separately for activities requiring near or distant vision as well as the degree of subjective satisfaction of patient via interview (NEI-VFQ 25). The purpose of measuring these parameters is to calculate, through a mathematical model, the relative effectiveness of each method.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cataract with stage 2 according to the Lens Opacities Classification System III (LOCS-3) grading scale
- •Age>45 years
排除标准
- •Disability to understand the Greek language and respond to the interview
- •Fundus or corneal diseases
- •Previous intraocular surgery
结局指标
主要结局
Binocular uncorrected intermediate reading acuity (bUIRA)
时间窗: 1 year
bUIRA is obtained using the near vision test of DDART at 60 cm distance.
Binocular uncorrected near reading acuity (bUNRA)
时间窗: 1 year
bUNRA is obtained using the near vision test of DDART at 40 cm distance.
Binocular uncorrected near critical print size (bUNCPS)
时间窗: 1 year
bUNCPS is obtained using the near vision test of DDART at 40 cm distance.
Binocular uncorrected intermediate critical print size (bUICPS)
时间窗: 1 year
bUICPS is obtained using the near vision test of DDART at 60 cm distance.
Binocular uncorrected distant visual acuity (bUDVA)
时间窗: 1 year
bUDVA is obtained using the distance vision test of DDART at four meters distance.
次要结局
- Spectacle independence(1 year)
- Dysphotopsia symptoms(1 year)
- Contrast sensitivity(1 year)
- Subjective satisfaction using Visual Function Index (VF-14) (total score, VF14-Near Vision (NV) score & VF14-Distance Vision (DV) score)(1 year)
研究者
Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Democritus University of Thrace