Phase 1 Evaluate the Visual Quality Change of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses; Phase 2 Evaluate the Tear Film Quality Dynamics of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens
研究概览
简要总结
In this study, the investigators examined the subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near visual acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI), OQAS value (OV),and the tear-film quality dynamics including the tear break-up time and the tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical quality analysis system (OQAS).
详细描述
50 eyes of 50 cataract patients scheduled for phacoemulsification surgery were recruited, the multifocal group (25 eyes) ，were implantation with Tecnis® ZMB00；and the monofocal group (25 eyes) were implantation with Tecnis® ZCB00.
Methods: All eyes were examined by logMAR visual acuity chart and Optical quality analysis system (OQAS) at 1 week, 1 month, 3 month, 6 month,12 month after surgery for the subjective and objective visual quality Change during the first year.
Measures:Subjective and objective visual quality were evaluated.Tear-film quality dynamicswere evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eyes with an axial length of 22.00 to 25.00 mm with age-related cataract.
排除标准
- •Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation.
- •Patients who could not be available for follow-up.
研究组 & 干预措施
monofocal IOLs group
monofocal IOLs group were implantation with Tecnis® ZCB00
干预措施: Diffractive multifocal IOLs group (Other)
Diffractive multifocal IOLs group
Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00
干预措施: Diffractive multifocal IOLs group (Other)
结局指标
主要结局
To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens
时间窗: 1week, 1month, 3month,6month,12month
Visual quality change during the first year after cataract surgery. The visual quality including the subjective and objective visual quality. The subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) and distance corrected near visual acuity (DCNVA). The objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI) and OQAS value (OV).
次要结局
- To evaluate the Tear-film Quality Dynamics of Eyes Implanted With Diffractive Multifocal Intraocular Lens(1week, 1month, 3month,6month,12month)
研究者
yin ying zhao
doctor of ophthalmology, Principal Investigator, Clinical Professor
Wenzhou Medical University