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临床试验/NCT06505434
NCT06505434尚未招募不适用

A Dynamic Study of Pupil Diameter After Artificial Lens Implantation in Patients With High Myopia

Shanghai Eye Disease Prevention and Treatment Center0 个研究点目标入组 60 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
pupil size

研究概览

简要总结

Age-related cataract remains the leading cause of blindness in developing countries. And, with the aging of the population in these countries, the number of cataract patients will continue to grow. With accurate biological measurements and the implantation of appropriate IOLs, most cataract patients can achieve good distance vision after surgery. However, it should not be overlooked that the current global prevalence of myopia is over 28.3% and is expected to reach 49.8% by 2050, while the rate of high myopia will increase from the current 4.0% to 9.8%. The prevalence of cataracts is significantly higher in the highly myopic population than in the orthoptic population.

The pupil is an important factor to be evaluated during the selection of an artificial lens (Intraocular lens, IOL), especially a functional IOL. It has been shown that the diameter and sensitivity of the pupil in patients with high myopia are also significantly different from those in the orthopneic population, and that there is a correlation with the adjustment status and refractive error. The purpose of this study is to investigate the following: 1. Whether the change of refractive status before and after IOL implantation in highly myopic cataract patients will lead to the change of pupil physiological characteristics, and whether the modification of preoperative measurement parameters can expand the population of myopic patients who can be reasonably applied to the functional IOL and obtain a high degree of satisfaction from patients. 2. Pupil diameter under a single fixed light source is a rough assessment for the screening of the population for functional IOLs, and this study was conducted in a single fixed light source. In this study, we measured the maximum value of pupil diameter, minimum value of pupil diameter, and rate of change of pupil diameter under bright vision and dark vision, and analyzed the correlation between the above three parameters and visual quality to further optimize the objective index of pupil diameter for the screening of functional IOL applicants.

Objectives of the study

  1. To observe the dynamic changes of pupil diameter and its visual quality before and after lens extraction combined with IOL implantation in myopic patients, and to analyze the correlation between the changes of pupil diameter and visual quality;
  2. To explore the patterns of refractive error and pupil biometric changes in myopic patients before and after IOL implantation, and to make corrections for the evaluation of preoperative biometric indexes for reference.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) a diagnosis of myopia: equivalent spherical lens extent (SE) SE ≤ -0.0 D when the eye is relaxed in accommodation; (2) a diagnosis of cataract; (3) surgical treatment with sequential lens ultrasonoemulsification combined with monofocal IOL implantation in both eyes at our hospital; and (4) consent to participate and cooperate in this study.

排除标准

  • (1) Symptoms of acute eye diseases, such as eye redness, eye pain, and increased eye discharge; (2) Other binocular eye diseases that seriously affect visual function, such as amblyopia, glaucoma, diabetic retinopathy, severe age-related macular degeneration and retinal detachment; (3) Intra-operative or post-operative complications from cataract surgery; combined with other ophthalmologic surgeries; and any other ophthalmologic surgeries in both eyes during the follow-up period; (4) History of injuries; (5) Inability to understand the informed consent; and (6) Inability to communicate. ) history of trauma; (5) inability to understand the informed consent form and inability to communicate.

结局指标

主要结局

pupil size

时间窗: 1 week ,1 month, 3 months

pupil size before and after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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