The Effect of Cataract Surgery for Age-related Cataract Patients on Circadian Rhythm and Sleep Quality
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Change from Objective sleep quality:actigraphy
研究概览
简要总结
A cataract is a clouding of the crystalline lens inside the eye, which leads to a decrease in vision. It is the most prevalent, treatable cause of visual impairment and blindness in the world. Cataract surgery with an intraocular lens (IOL) implant is one of the most common and thought to be the most effective surgical procedure in any field of medicine. In this trial, the investigators aimed to evaluate the effect of cataract surgery on circadian rhythm and sleep as well as the effect of the blue light transmission characteristics of the implanted IOL on sleep.
详细描述
A Prospective, randomized controlled study of 10000 participants(20000 eyes) with dense nucleus were enrolled. Patients were assigned to two groups: Group I: neutral IOL implanted in eye while in Group II, blue-blocking IOL was innovatively implanted in the eye.
A cataract is a clouding of the crystalline lens inside the eye, which leads to a decrease in vision. It is the most prevalent, treatable cause of visual impairment and blindness in the world. Cataract surgery with an intraocular lens (IOL) implant is one of the most common and thought to be the most effective surgical procedure in any field of medicine.
In this trial, the investigators aimed to evaluate the effect of cataract surgery on circadian rhythm and sleep as well as the effect of the blue light transmission characteristics of the implanted IOL on sleep. Patients enrolled into the study will be assessed in 3 months before the surgery and 3 months after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral age-related cataract scheduled for cataract surgery
排除标准
- •Vision-impairing ophthalmic disease: Glaucoma, AMD, DR.et.al
- •Severe systemic disease: Diabetes, Sleep disorder.et.al
- •Vision-impairing complications: Ruptured posterior capsule, Persistent cornea edema.et.al
研究组 & 干预措施
Neutral IOL
Phacoemulsification cataract surgery is performed with neutral IOL implantation.
干预措施: Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation (Procedure)
Neutral IOL
Phacoemulsification cataract surgery is performed with neutral IOL implantation.
干预措施: Subconjunctival dexamethasone and general anesthesia (Drug)
Neutral IOL
Phacoemulsification cataract surgery is performed with neutral IOL implantation.
干预措施: Viscoelastic materials (Drug)
Blue-blocking IOL
Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation.
干预措施: Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation (Procedure)
Blue-blocking IOL
Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation.
干预措施: Subconjunctival dexamethasone and general anesthesia (Drug)
Blue-blocking IOL
Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation.
干预措施: Viscoelastic materials (Drug)
结局指标
主要结局
Change from Objective sleep quality:actigraphy
时间窗: 3 months before the surgery and 3 months after the surgery
Change from Post-illumination pupil response (PIPR)
时间窗: 3 months before the surgery and 3 months after the surgery
Change from Subjective sleep quality: PSQI
时间窗: 3 months before the surgery and 3 months after the surgery
次要结局
未报告次要终点
研究者
Haotian Lin
Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center
Sun Yat-sen University