The Effect of Cataract Surgery on Sleep Quality

October 30, 2015 updated by: Haotian Lin, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Post-illumination pupil response (PIPR)
Time Frame: 3 months before the surgery and 3 months after the surgery
3 months before the surgery and 3 months after the surgery
Change from Objective sleep quality:actigraphy
Time Frame: 3 months before the surgery and 3 months after the surgery
3 months before the surgery and 3 months after the surgery
Change from Subjective sleep quality: PSQI
Time Frame: 3 months before the surgery and 3 months after the surgery
3 months before the surgery and 3 months after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Ministry of Health, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPMOH2010-China8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe