The Effect of Cataract Surgery on Sleep Quality

NCT02593669 | Unknown DMC

• 1 other identifier: CCPMOH2010-China8
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Sleep

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Neutral IOL

EXPERIMENTAL

Phacoemulsification cataract surgery is performed with neutral IOL implantation.

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

Blue-blocking IOL

EXPERIMENTAL

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

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

Interventions

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

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

Neutral IOL

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

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

Blue-blocking IOL

Subconjunctival dexamethasone and general anesthesia DRUG

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

Blue-blocking IOL; Neutral IOL

Viscoelastic materials DRUG

viscoelastic materials are used to protect corneal endothelial cells.

Blue-blocking IOL; Neutral IOL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral age-related cataract scheduled for cataract surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Ministry of Health, China: collaborator

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (3)

• 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.

  PMID: 26233628 BACKGROUND

• 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.

  PMID: 24701992 BACKGROUND

• 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.

  PMID: 23145881 BACKGROUND

Related Links

• Description Home page of Zhongshan Ophthalmic Center

MeSH Terms

Conditions

Cataract

Interventions

Drug Implants; Anesthesia, General

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations; Anesthesia; Anesthesia and Analgesia

Study Officials

• Haotian Lin, M.D., Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Yizhi Liu, M.D., Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

• Weirong Chen, M.D.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 2, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 2, 2015

Record last verified: 2015-10

Locations

CN (1)