The Effect of Cataract Surgery on Sleep Quality
- Conditions
- SleepCataract
- Interventions
- Procedure: Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantationProcedure: Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantationDrug: Viscoelastic materials
- Registration Number
- NCT02593669
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10000
- Bilateral age-related cataract scheduled for cataract surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neutral IOL Subconjunctival dexamethasone and general anesthesia Phacoemulsification cataract surgery is performed with neutral IOL implantation. Blue-blocking IOL Subconjunctival dexamethasone and general anesthesia Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation. Neutral IOL Viscoelastic materials Phacoemulsification cataract surgery is performed with neutral IOL implantation. Blue-blocking IOL Viscoelastic materials Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation. Neutral IOL Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation Phacoemulsification cataract surgery is performed with neutral IOL implantation. Blue-blocking IOL Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation.
- Primary Outcome Measures
Name Time Method Change from Objective sleep quality:actigraphy 3 months before the surgery and 3 months after the surgery Change from Post-illumination pupil response (PIPR) 3 months before the surgery and 3 months after the surgery Change from Subjective sleep quality: PSQI 3 months before the surgery and 3 months after the surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China