The Effect of Cataract Surgery on Sleep Quality

NCT ID: NCT02593669

Last Updated: 2015-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Cataract Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Neutral IOL

Phacoemulsification cataract surgery is performed with neutral IOL implantation.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation

Subconjunctival dexamethasone and general anesthesia

Intervention Type DRUG

All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.

Viscoelastic materials

Intervention Type DRUG

viscoelastic materials are used to protect corneal endothelial cells.

Blue-blocking IOL

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

The phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation.

Subconjunctival dexamethasone and general anesthesia

Intervention Type DRUG

All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.

Viscoelastic materials

Intervention Type DRUG

viscoelastic materials are used to protect corneal endothelial cells.

Interventions

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

The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation

Intervention Type PROCEDURE

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

The phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation.

Intervention Type PROCEDURE

Subconjunctival dexamethasone and general anesthesia

All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.

Intervention Type DRUG

Viscoelastic materials

viscoelastic materials are used to protect corneal endothelial cells.

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, China

OTHER_GOV

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haotian Lin, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Yizhi Liu, M.D., Ph.D

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Weirong Chen, M.D.

Role: STUDY_DIRECTOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Facility Contacts

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Haotian Lin, M.D., Ph.D.

Role: primary

8613802793086

Jing Li, M.D.

Role: backup

+86-20-87330341

References

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Brondsted AE, Sander B, Haargaard B, Lund-Andersen H, Jennum P, Gammeltoft S, Kessel L. The Effect of Cataract Surgery on Circadian Photoentrainment: A Randomized Trial of Blue-Blocking versus Neutral Intraocular Lenses. Ophthalmology. 2015 Oct;122(10):2115-24. doi: 10.1016/j.ophtha.2015.06.033. Epub 2015 Jul 30.

Reference Type BACKGROUND
PMID: 26233628 (View on PubMed)

Ayaki M, Negishi K, Tsubota K. Rejuvenation effects of cataract surgery with ultraviolet blocking intra-ocular lens on circadian rhythm and gait speed. Rejuvenation Res. 2014 Aug;17(4):359-65. doi: 10.1089/rej.2014.1550.

Reference Type BACKGROUND
PMID: 24701992 (View on PubMed)

Ayaki M, Muramatsu M, Negishi K, Tsubota K. Improvements in sleep quality and gait speed after cataract surgery. Rejuvenation Res. 2013 Feb;16(1):35-42. doi: 10.1089/rej.2012.1369.

Reference Type BACKGROUND
PMID: 23145881 (View on PubMed)

Related Links

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http://www.gzzoc.com/

Description Home page of Zhongshan Ophthalmic Center

Other Identifiers

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CCPMOH2010-China8

Identifier Type: -

Identifier Source: org_study_id

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