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The Effect of Cataract Surgery on Sleep Quality

Primary Purpose

Cataract, Sleep

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

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

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

Subconjunctival dexamethasone and general anesthesia

Viscoelastic materials

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Neutral IOL

Blue-blocking IOL

Arm Description

Phacoemulsification cataract surgery is performed with neutral IOL implantation.

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

Outcomes

Primary Outcome Measures

Change from Post-illumination pupil response (PIPR)

Change from Objective sleep quality:actigraphy

Change from Subjective sleep quality: PSQI

Secondary Outcome Measures

Full Information

NCT ID

NCT02593669

First Posted

October 28, 2015

Last Updated

October 30, 2015

Sponsor

Sun Yat-sen University

Collaborators

Ministry of Health, China

1. Study Identification

Unique Protocol Identification Number

NCT02593669

Brief Title

The Effect of Cataract Surgery on Sleep Quality

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

Ministry of Health, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract, Sleep

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neutral IOL

Arm Type

Experimental

Arm Description

Phacoemulsification cataract surgery is performed with neutral IOL implantation.

Arm Title

Blue-blocking IOL

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Subconjunctival dexamethasone and general anesthesia

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Viscoelastic materials

Intervention Description

viscoelastic materials are used to protect corneal endothelial cells.

Primary Outcome Measure Information:

Title

Change from Post-illumination pupil response (PIPR)

Time Frame

3 months before the surgery and 3 months after the surgery

Title

Change from Objective sleep quality:actigraphy

Time Frame

3 months before the surgery and 3 months after the surgery

Title

Change from Subjective sleep quality: PSQI

Time Frame

3 months before the surgery and 3 months after the surgery

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haotian Lin, M.D., Ph.D

Organizational Affiliation

Zhongshan Ophthalmic Center, Sun Yat-sen University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yizhi Liu, M.D., Ph.D

Organizational Affiliation

Zhongshan Ophthalmic Center, Sun Yat-sen University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Weirong Chen, M.D.

Organizational Affiliation

Zhongshan Ophthalmic Center, Sun Yat-sen University

Official's Role

Study Director

Facility Information:

Facility Name

Zhongshan Ophthalmic Center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

8613802793086

haot.lin@hotmail.com

First Name & Middle Initial & Last Name & Degree

Jing Li, M.D.

Phone

+86-20-87330341

Reviewborad_SYsU@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

26233628

Citation

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.

Results Reference

background

PubMed Identifier

24701992

Citation

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.

Results Reference

background

PubMed Identifier

23145881

Citation

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.

Results Reference

background

Links:

URL

http://www.gzzoc.com/

Description

Description Home page of Zhongshan Ophthalmic Center

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The Effect of Cataract Surgery on Sleep Quality

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