Cataract, Sleep
Conditions
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.
Interventions
PROCEDUREPhacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation
The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation
PROCEDUREPhacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation
The phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation.
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
viscoelastic materials are used to protect corneal endothelial cells.
Sponsors
Ministry of Health, China
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Bilateral age-related cataract scheduled for cataract surgery
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Post-illumination pupil response (PIPR) | 3 months before the surgery and 3 months after the surgery |
| Change from Objective sleep quality:actigraphy | 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 |
Countries
China
Outcome results
None listed