The Effect of Cataract Surgery on Sleep Quality
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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. |
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.
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.
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
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
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Vision-impairing complications: Ruptured posterior capsule, Persistent cornea edema.et.al
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
- Ministry of Health, China
Investigators
- Principal Investigator: Haotian Lin, M.D., Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study Chair: Yizhi Liu, M.D., Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study Director: Weirong Chen, M.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- CCPMOH2010-China8