CataractNCT02593669
The Effect of Cataract Surgery on Sleep Quality
A study testing Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation, Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation and Subconjunctival dexamethasone and general anesthesia in people with Cataract and Sleep, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation, Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation and Subconjunctival dexamethasone and general anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Bilateral age-related cataract scheduled for cataract surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D., 8613802793086, haot.lin@hotmail.com
Jing Li, M.D., +86-20-87330341, Reviewborad_SYsU@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- 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
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantationProcedure or surgery
The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation
Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantationProcedure or surgery
The phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation.
Subconjunctival dexamethasone and general anesthesiaDrug
All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
Viscoelastic materialsDrug
viscoelastic materials are used to protect corneal endothelial cells.
| Study group | Role | What they receive |
|---|---|---|
| Neutral IOL | Experimental | Phacoemulsification cataract surgery is performed with neutral IOL implantation. Receives: 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. Receives: Procedure: Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation; Drug: Subconjunctival dexamethasone and general anesthesia; Drug: Viscoelastic materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Post-illumination pupil response (PIPR)
Measured: 3 months before the surgery and 3 months after the surgery
Change from Objective sleep quality:actigraphy
Measured: 3 months before the surgery and 3 months after the surgery
Change from Subjective sleep quality: PSQI
Measured: 3 months before the surgery and 3 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D., Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D., Ph.D, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityWeirong Chen, M.D., Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593669
- Sponsor's protocol ID
- CCPMOH2010-China8
- Status last verified
- Oct 2015
- First submitted
- 28 Oct 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26233628Ayaki 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.
PubMed 24701992Ayaki 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.
PubMed 23145881
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cataract Surgery for Age-related Cataract Patients on Circadian Rhythm and Sleep Quality
- ClinicalTrials.gov ID
- NCT02593669
- Acronym / sponsor ID
- CCPMOH2010-China8
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral IOL | Experimental | Procedure: Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation, Drug: Subconjunctival dexamethasone and general anesthesia, Drug: Viscoelastic materialsPhacoemulsification cataract surgery is performed with neutral IOL implantation. |
| Blue-blocking IOL | Experimental | Procedure: Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation, Drug: Subconjunctival dexamethasone and general anesthesia, Drug: Viscoelastic materialsPhacoemulsification cataract surgery is performed with blue-blocking IOL implantation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Bilateral age-related cataract scheduled for cataract surgery
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantationThe phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation | Procedure or surgery | Neutral IOL |
| Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantationThe phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation. | Procedure or surgery | Blue-blocking IOL |
| Subconjunctival dexamethasone and general anesthesiaAll patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia. | Drug | Blue-blocking IOL, Neutral IOL |
| Viscoelastic materialsviscoelastic materials are used to protect corneal endothelial cells. | Drug | Blue-blocking IOL, Neutral IOL |
Primary outcome
Change from Post-illumination pupil response (PIPR)
Time frame: 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
Change from Subjective sleep quality: PSQI
Time frame: 3 months before the surgery and 3 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Background: PubMed 26233628Brondsted 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.
- Background: PubMed 24701992Ayaki 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.
- Background: PubMed 23145881Ayaki 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.
- Description Home page of Zhongshan Ophthalmic CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
Haotian Lin, M.D., Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D. study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation, Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation and Subconjunctival dexamethasone and general anesthesia in people with Cataract and Sleep, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Post-illumination pupil response (PIPR) (time frame: 3 months before the surgery and 3 months after the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02593669, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.