The Effect of Cataract Surgery on Sleep Quality

Sun Yat-sen University

Status: Unknown

Conditions: Cataract; Sleep

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02593669

CCPMOH2010-China8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10,000 participants in 2 patient groups

Neutral IOL

Experimental group

Description:

Phacoemulsification cataract surgery is performed with neutral IOL implantation.

Treatment:

Drug: Subconjunctival dexamethasone and general anesthesia

Procedure: Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation

Drug: Viscoelastic materials

Blue-blocking IOL

Experimental group

Description:

Phacoemulsification cataract surgery is performed with blue-blocking IOL implantation.

Treatment:

Drug: Subconjunctival dexamethasone and general anesthesia

Drug: Viscoelastic materials

Procedure: Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation