The Effect of Cataract Surgery on Sleep Quality

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02593669
• Other study ID #: CCPMOH2010-China8
• Status: Not yet recruiting
• Phase: N/A
• First received: October 28, 2015
• Last updated: October 30, 2015
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Sleep

Intervention

Procedure:
• Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation
The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation
• 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.

Drug:
• Subconjunctival dexamethasone and general anesthesia
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
• Viscoelastic materials
viscoelastic materials are used to protect corneal endothelial cells.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Ministry of Health, China

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View Citation

Brøndsted 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Post-illumination pupil response (PIPR)		3 months before the surgery and 3 months after the surgery	No
Primary	Change from Objective sleep quality:actigraphy		3 months before the surgery and 3 months after the surgery	No
Primary	Change from Subjective sleep quality: PSQI		3 months before the surgery and 3 months after the surgery	No

External Links

•   Description Home page of Zhongshan Ophthalmic Center