Comparison on Visual and Refractive Outcomes of Four Different Types of IOL in Patients With Cataracts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Postoperative visual acuity
研究概览
简要总结
The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into 4 groups. Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.
详细描述
The objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (IOL) in patients underwent cataracts surgery. This was a retrospective study. Patients with age-related cataract underwent phacoemulsification combined with IOLs implantation. Patients were divided into group A (TECNIS PCB00 IOL), Group B (HumanOptics Diff-Aay IOL), Group C (TECNIS Symfony ZXR00 IOL) and group D (ZEISS AT LISA tri 839MP IOL). Uncorrected distant visual acuity(UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA),and the best corrected visual acuity (BCVA) 1 month and 3 months after the surgery were determined. The defocus curve, contrast sensitivity, and customized VF-14-oriented Visual Function Index questionnaire were performed 3 months postoperatively. Kruskal-Wallis test and generalized estimating equation(GEE) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age-related cataract with myopia≤-6.0D and over 0.0D
- •axial length≤26mm and corneal astigmatism≤1.5D
- •well-cooperation of finishing preoperative examinations
- •completion of all follow-up visits
排除标准
- •previous eye diseases that affect vision including keratopathy, glaucoma, uveitis, amblyopia, fundus diseases, etc.
- •patients with decreased cognitive ability, unable to cooperate with preoperative examination, or suffering from severe anxiety, depression and mental illness
- •serious complications during operation, including corneal injury, iris injury, expelling choroidal hemorrhage, posterior capsule rupture, etc
- •serious postoperative complications, including displacement of intraocular lens, macular edema, endophthalmitis, etc
- •follow-ups less than 3months
结局指标
主要结局
Postoperative visual acuity
时间窗: 3 months
The uncorrected distant visual acuity(UDVA), the best corrected distant visual acuity (BCVA) (5 m), the uncorrected intermediate visual acuity(UIVA) (80 cm) and the uncorrected near visual acuity(UIVA) (40 cm) were chosen as the index to evaluate the VA. The UDVA and BCVA were examined by logarithmic visual acuity chart. The UIVA and UIVA were examined by using a near eye chart.They were all measured 1 month and 3 months after the surgery.
Postoperative contrast sensitivity
时间窗: 3 months
The contrast sensitivity was used to conduct the assessment by CSV-1000E (VectorVision, USA) under photopic (85 cd/m2) condition at a 2.5m distance. The logarithmic values for 3, 6, 12, and 18 cycles/degree (c/d) were analyzed 3 months postoperatively.
Postoperative defocus curve
时间窗: 3 months
Defocus curve was used to evaluate the visual quality of functional intraocular lens after surgery. The insertion range was -4.0 D \~ + 2.0 D, increasing by 0.5 D. The best corrected distant visual acuity was recorded at each diopter 3 months postoperatively.
Postoperative eye-related quality of life
时间窗: 3 months after surgery
Based on the American Questionnaire on Visual Function Index-14 (VF-14), the Chinese-oriented version(VF-12-CN) was used to investigate the postoperative near-vision, visual satisfaction, ocular discomfort, visual disturbance, and subjective feelings of far-vision, middle-vision and near-vision. Each question was divided into 4 levels and the scores ranked from 0 to 3 points. Considering the visual interference such as glare and halo, the evaluation of glare and halo visual interference phenomenon was also added.
次要结局
未报告次要终点
研究者
Sun Yilin
Resident Physician
Shanghai 10th People's Hospital