Visual Outcomes After Implantation of a Segmental Refractive Multifocal Intraocular Lens Following Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity at far distance
研究概览
简要总结
To evaluate visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after cataract surgery.
详细描述
Purpose: This prospective, nonrandomized noncomparative case series investigates the visual performance after bilateral implantation of a segmental refractive multifocal intraocular lenses (IOL) after cataract surgery and was performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.
Methods: Fifty eyes (25 patients) were included. Inclusion criteria were bilateral cataract, age > 45 years, corneal astigmatism ≤ 0.75 D postoperatively, pupil size 3 to 6 mm (mesopic), and center shift < 1 mm (Pentacam). Exclusion criteria were previous ocular surgeries, amblyopia or potential postoperative distance-corrected visual acuity (DCVA) < 0.3 logMAR,
Intervention or Observation: Uncorrected (UCVA) and DCVA in 4 m, 80 cm, 40 cm; contrast sensitivity (CS) under photopic and mesopic conditions; reading skills (Radner Reading Charts); defocus curve, questionnaire on optical quality (OQ) and spectacle independence were assessed after 3 months.
Main Outcome Measures: At 3 months postoperatively, UCVA and DCVA in 4 m, 80 cm, 40 cm (logMAR); defocus curves; CS; reading skills; and OQ questionnaire results.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •bilateral cataract
- •age > 45 years
- •corneal astigmatism ≤ 0.75 D postoperatively
- •pupil size 3 to 6 mm (mesopic)
- •center shift < 1 mm
排除标准
- •previous ocular surgeries
- •amblyopia
- •potential postoperative distance-corrected visual acuity (DCVA) < 0.3 logMAR
结局指标
主要结局
Best corrected visual acuity at far distance
时间窗: Measured 3 month after lens surgery
Monocular and binocular corrected visual acuity at far distance measured in logMAR 3 month after lens surgery
次要结局
- Best corrected visual acuity at intermediate distance(Measured 3 month after lens surgery)
- Best corrected visual acuity at near distance(Measured 3 month after lens surgery)
- Uncorrected visual acuity at intermediate distance(Measured 3 month after lens surgery)
- Uncorrected visual acuity at far distance(Measured 3 month after lens surgery)
- Uncorrected visual acuity at near distance(Measured 3 month after lens surgery)
- Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions(Measured 3 month after lens surgery)
- Defocus curve testing(Measured 3 month after lens surgery)
- Optical quality questionnaire(Measured 3 month after lens surgery)
- Radner reading skills(Measured 3 month after lens surgery)
研究者
Myriam Böhm, MD
Professor Dr. med. Thomas Kohnen
University Clinic Frankfurt