Comparison of Quality of Vision After Bifocal and Extended Depth of Focus Intraocular Lens Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Wavefront examination
研究概览
简要总结
To compare the visual performance of the extended depth of focus (EDOF) intraocular lens (IOL) to bifocal and spherical monofocal IOL
详细描述
This study was conducted from 2018 to 2020. This study included patients who were with presence of cataract in both eyes, age between 50 and 80 years, and corrected distance visual acuity (CDVA) of both eyes under 20/40. Phacoemulsification cataract surgery was arranged for both eyes for all patients. The study groups of IOL models include EDOF Symfony IOL (AMO, Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal Sensar AR40e IOL (AMO, Santa Ana, CA, USA). The patients were routinely examined preoperatively as well as 1 month after surgery for far and near visual acuity (in LogMAR unit). Contrast sensitivity, wavefront aberration and quality of vision questionnaire was measured at the 1-month postoperative visit. These aforementioned outcomes were recorded and compared between groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •presence of cataract in both eyes
- •age between 50 and 80 years
- •CDVA of both eyes under 20/40
- •Phacoemulsification cataract surgery was arranged for both eyes
排除标准
- •complicated cataract
- •corneal opacities or irregularities
- •corneal astigmatism > 1.5 diopter
- •dry eye (Schirmer's test I ≤ 5mm)
- •amblyopia
- •anisometropia
- •surgical complications such as posterior capsular bag rupture or vitreous loss
- •IOL tilt or decentration
- •coexisting ocular pathologies
- •non-dilating pupil
- •history of intraocular surgery, laser therapy, or retinopathy
- •optic nerve or macular diseases
- •refusal or unable to maintain follow-up.
结局指标
主要结局
Wavefront examination
时间窗: at the 1-month postoperative visit
Wavefront analysis was performed only at the 1-month postoperative visit with an AMO WaveScan Hartmann-Shack sensor (Santa Clara, CA, USA). The wavefront maps were analyzed using a 6-mm pupil diameter and a Zernike polynomial expansion up to the sixth-order of Zernike coefficients. Higher order aberrations including RMS errors of horizontal coma aberration (Z 3,1), spherical aberration (4,0), trefoil aberration and the higher order aberrations were assessed.
Contrast sensitivity
时间窗: at the 1-month postoperative visit
CS was also measured at the 1-month postoperative visit using the Vector Vision CSV-1000 (Greenville, OH, USA) chart. All subjects were tested at the recommended distance of 8 feet. The CSV-1000 consists of a series of circular achromatic sine-wave patches having a 1.5-in. diameter and comprising 4 rows, each corresponding to one of 4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd). We selected 3, 6 and 12 cpd for analysis.
Questionnaire
时间窗: at the 1-month postoperative visit
Subjective QoV was evaluated using a questionnaire adopted from a near-activity 19-item questionnaire and the NEI-RQL-42. Our questionnaire contains 11 questions and the subscales include far vision, diurnal fluctuation, glare and halos, spectacle dependence, near vision, and intermediate vision. In general, questionnaires were completed without assistance; however, on the patient's request, explanations of the questions were provided.
Ophthalmic examinations
时间窗: 1 month after surgery.
far uncorrected visual acuity(UCVA) and corrected distance visual acuity (CDVA), near UCVA in LogMAR unit
次要结局
未报告次要终点
研究者
Chao-Kai Chang
Dean, Nobel Eye Institute
Taipei Nobel Eye Clinic