The Effect of Cataract Surgery on Sleep Quality

Study Overview
=================
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.

Official Title
-----------------
The Effect of Cataract Surgery for Age-related Cataract Patients on Circadian Rhythm and Sleep Quality

Conditions
-----------------
Cataract, Sleep

Intervention / Treatment
-----------------
* Procedure: Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation
* Procedure: Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation
* Drug: Subconjunctival dexamethasone and general anesthesia
* Drug: Viscoelastic materials


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neutral IOL<br>Phacoemulsification cataract surgery is performed with neutral IOL implantation. | Procedure: Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation<br>* The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation<br>Drug: Subconjunctival dexamethasone and general anesthesia<br>* All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.<br>Drug: Viscoelastic materials<br>* viscoelastic materials are used to protect corneal endothelial cells.<br>|
| Experimental: Blue-blocking IOL<br>Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation. | Procedure: Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation<br>* The phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation.<br>Drug: Subconjunctival dexamethasone and general anesthesia<br>* All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.<br>Drug: Viscoelastic materials<br>* viscoelastic materials are used to protect corneal endothelial cells.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |