Comparison of the Clinical Outcomes of Extended Depth of Focus Intraocular Lenses and Monofocal Intraocular Lenses in Patients With High Myopia Undergoing Cataract Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Defocus curve
研究概览
简要总结
Comparison of Postoperative Outcomes in Patients with High Myopia Undergoing Cataract Surgery Implanted with Extended Depth of Focus Intraocular Lens (ICB00) and Monofocal Intraocular Lens (ZCB00)
详细描述
In this study, we aim to compare the visual outcomes and quality of life between highly myopic patients with cataracts who receive implantation of extended depth of focus (EDOF) intraocular lenses (ICB00) and monofocal intraocular lenses (ZCB00). This is a case-control study, planning to recruit 64 highly myopic patients with cataracts, aged between 40 and 70, with 32 in each group. The primary endpoints of the study are the best-corrected visual acuity (BCVA) and defocus curve at 6 months postoperatively. Secondary endpoints include uncorrected visual acuity (UCVA), contrast sensitivity, intraocular pressure, and assessments of patient satisfaction and quality of life. These will be evaluated using standardized questionnaires such as the VF-14, the PRSIQ spectacle dependency scale, and reading speed tests to quantify changes in vision-related quality of life. Patients will undergo comprehensive ophthalmic examinations preoperatively and at 6 months postoperatively, including slit-lamp anterior segment examination, fundus examination, corneal topography, and intraocular pressure testing. Additionally, questionnaires will be used to assess patients' subjective satisfaction with visual improvement and spectacle needs in daily life. All data will be statistically analyzed to compare the effects of the two types of intraocular lenses. Continuous variables will be analyzed using t-tests or Mann-Whitney U tests, and categorical variables will be analyzed using chi-square tests. The level of statistical significance is set at p<0.05. Through this study, we hope to determine whether the use of EDOF intraocular lenses provides better visual outcomes and quality of life compared to monofocal intraocular lenses in highly myopic patients with cataracts. The results of this study will provide a more scientific basis for the choice of intraocular lenses in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: The patients are between 40 and 70 years old.
- •2: Ocular axis > 26mm
- •3: Able to understand, cooperate and complete all follow-up.
排除标准
- •1: Moderate and severe dry eye
- •2: There is macular degeneration complicated by high myopia.
- •3: Combined with other ophthalmic diseases
- •4: Previous history of ophthalmic surgery.
- •5: There are intraoperative or postoperative complications.
结局指标
主要结局
Defocus curve
时间窗: Three months after operation
On the basis of BCDVA, add +2.5\~-5.0D spherical lenses (decreasing at intervals of 0.5D) before the patient's operation, record the logMAR vision of the patient at each added spherical lens degree, and draw the average Defocus Curve with the added spherical lens degree as the abscissa and the average vision of each corresponding degree as the ordinate.
Far, middle and near vision
时间窗: Three months after operation
The naked eye vision was measured at 5m, 70cm and 40cm respectively.
次要结局
未报告次要终点
研究者
Yune Zhao
Vice president of Eye Hospital of Wenzhou Medical University
Wenzhou Medical University