Cataract SurgeryICSSESNCT03020056
Impact of Cataract Surgery to Socioeconomic Status in Rural Area
A study testing Phacolin eye drops and cataract surgery in people with Cataract Surgery, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This is a randomized controlled trial to investigate the effect of cataract surgery on the socioeconomic status of cataract patients in rural area of Southern China. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Phacolin eye drops and cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2017to 29 Jun 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related cataract patients aged over 50 with best corrected visual acuity (BCVA) less than 0.3 in the better eye.
Who cannot join
- History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.
- Cases in need of expedited surgery, including shallow anterior chamber (central anterior chamber depth less than 2 mm and/or peripheral anterior chamber depth less than 1/4 corneal thickness), blindness of grade IV and V (BCVA less than 0.02 in the better eye), and intumescent or hypermature stage of cortical cataract.
- Systemic disease dampening activity, including cardiovascular and cerebrovascular diseases, hemiplegia, neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease.
- Patients not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Cataract Surgery to Socioeconomic Status in Rural Area of Southern China: A Randomised Controlled Trial
This is a randomized controlled trial to investigate the effect of cataract surgery on the socioeconomic status of cataract patients in rural area of Southern China.
Read the detailed description
Cataract is the leading cause of visual impairment worldwide and surgery is the only effective treatment. Previous studies show that visual impairment impacts the patient's socioeconomic status(SES). However, how cataract surgery affects the SES of cataract patients in rural area of China has not been determined before.
In the investigators study, cataract patients in rural area of Southern China will be enrolled and randomly divided into two groups. Cataract surgery will be performed in 4 weeks in intervention group, while performed at 1 year later in control group. The annual personal income by work, annual household income, hours in paid and unpaid work in the previous month, real estate ownership, household expenditures and quality of life will be investigated before and 1 year after surgery. Then, the difference in SES and quality of life change between two groups at 1 year later will be assessed.
- Conditions
- Cataract Surgery
- Being tested
- Phacolin eye drops, cataract surgery
- Keywords
- cataract surgery, socioeconomic status, quality of life, rural area, China, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacolin eye dropsDrug
Also called antioxidant eye drops
After enrollment, the participants will be provided antioxidant eye drops, Phacolin (Zhongshan ophthalmic center, China) for free.The eye drops will be administered 4 times per day for 1 year.Then either phacoemulsification or manual small incision cataract surgery will be performed.
cataract surgeryProcedure or surgery
Also called phacoemulsification or MSICS
After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| waiting surgery | Placebo comparator | Cataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China). Receives: Drug: Phacolin eye drops |
| expedited surgery | Experimental | Cataract surgery will be performed within 4 weeks. Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
annual personal income by work in Chinese Yuan
The annual personal income comprises of the direct and the indirect income by work. The indirect income is derived from unpaid work and calculated as follows: unpaid work time × local income per hour.
Measured: 1 year
Secondary outcomes (2)
Health-related quality of life score
Health-related QoL score will be measured by EuroQol 5 dimensions with 5 levels (EQ-5D-5L) and self-rated health (SRH). For each dimension, participants are asked to mark between 1: "no problems" to 5: "unable to/extreme problems". Self-rated health using a vertical Visual Analogue Scale (VAS), with scores ranging from 0 (representing worst imaginable health state) to 100 (best imaginable health state).
- mobility
- self-care
- usual activities
- pain/discomfort
- anxiety/depression f: self-rated health
Measured: 1 year
Vision related quality of life score
Vision related QoL score will be measured by Catquest-9S, which is a short form of Catquest questionnaire. The Catquest-9SF questionnaire comprises 7 questions for performing daily-life activities and 2 global questions about difficulties in general and satisfaction with vision (1= very great difficulty; 2= great difficulty; 3= some difficulty; 4= no difficulty).
- reading text in the newspaper
- recognizing faces of people you meet
- seeing prices of goods when shopping
- seeing to walk on uneven ground
- seeing to do needlework and handicraft
- reading text on television
- seeing to carry out a preferred hobby
- difficulty in daily life
- satisfaction on present vision
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start16 Jan 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, 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
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Yizhi Liu, Doctor, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYingfeng Zheng, Doctor, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020056
- Sponsor's protocol ID
- 2016KYYJ007
- Acronym
- ICSSES
- Status last verified
- Mar 2021
- First submitted
- 26 Nov 2016
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Tan X, Han X, Zheng Y, Jin L, Qiu X, Zhu Y, Chen C, Zhang J, Dickey H, Wang D, Huang S, Liu B, Liang X, Zeng Y, Lin H, He M, Luo L, Huang W, Congdon N, Liu Y. Impact of Cataract Surgery on Income in Rural Southern China: The SUCCESS Randomized Controlled Trial. Asia Pac J Ophthalmol (Phila). 2023 Jul-Aug 01;12(4):355-363. doi: 10.1097/APO.0000000000000624. Epub 2023 Jul 21.
PubMed 37523426
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cataract Surgery to Socioeconomic Status in Rural Area of Southern China: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03020056
- Acronym / sponsor ID
- ICSSES / 2016KYYJ007
- Conditions
- Cataract Surgery
- Keywords
- cataract surgery, socioeconomic status, quality of life, rural area, China, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 13 Jan 2017 (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.
This is a randomized controlled trial to investigate the effect of cataract surgery on the socioeconomic status of cataract patients in rural area of Southern China.
Detailed description
Cataract is the leading cause of visual impairment worldwide and surgery is the only effective treatment. Previous studies show that visual impairment impacts the patient's socioeconomic status(SES). However, how cataract surgery affects the SES of cataract patients in rural area of China has not been determined before.
In the investigators study, cataract patients in rural area of Southern China will be enrolled and randomly divided into two groups. Cataract surgery will be performed in 4 weeks in intervention group, while performed at 1 year later in control group. The annual personal income by work, annual household income, hours in paid and unpaid work in the previous month, real estate ownership, household expenditures and quality of life will be investigated before and 1 year after surgery. Then, the difference in SES and quality of life change between two groups at 1 year later will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| waiting surgery | Placebo comparator | Drug: Phacolin eye dropsCataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China). |
| expedited surgery | Experimental | Procedure: cataract surgeryCataract surgery will be performed within 4 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age-related cataract patients aged over 50 with best corrected visual acuity (BCVA) less than 0.3 in the better eye.
Key exclusion criteria (4 listed)
- History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.
- Cases in need of expedited surgery, including shallow anterior chamber (central anterior chamber depth less than 2 mm and/or peripheral anterior chamber depth less than 1/4 corneal thickness), blindness of grade IV and V (BCVA less than 0.02 in the better eye), and intumescent or hypermature stage of cortical cataract.
- Systemic disease dampening activity, including cardiovascular and cerebrovascular diseases, hemiplegia, neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease.
- Patients not willing to participate in the study.
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 |
|---|---|---|
| Phacolin eye dropsAlso: antioxidant eye dropsAfter enrollment, the participants will be provided antioxidant eye drops, Phacolin (Zhongshan ophthalmic center, China) for free.The eye drops will be administered 4 times per day for 1 year.Then either phacoemulsification or manual small incision cataract surgery will be performed. | Drug | waiting surgery |
| cataract surgeryAlso: phacoemulsification or MSICSAfter enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks. | Procedure or surgery | expedited surgery |
Primary outcome
annual personal income by work in Chinese Yuan
Time frame: 1 year
The annual personal income comprises of the direct and the indirect income by work. The indirect income is derived from unpaid work and calculated as follows: unpaid work time × local income per hour.
2 secondary outcomes
Health-related quality of life score
Time frame: 1 year
Vision related quality of life score
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 37523426Tan X, Han X, Zheng Y, Jin L, Qiu X, Zhu Y, Chen C, Zhang J, Dickey H, Wang D, Huang S, Liu B, Liang X, Zeng Y, Lin H, He M, Luo L, Huang W, Congdon N, Liu Y. Impact of Cataract Surgery on Income in Rural Southern China: The SUCCESS Randomized Controlled Trial. Asia Pac J Ophthalmol (Phila). 2023 Jul-Aug 01;12(4):355-363. doi: 10.1097/APO.0000000000000624. Epub 2023 Jul 21.
- Individual participant dataSharing planned: Undecided
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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.
Yizhi Liu, Doctor principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yingfeng Zheng, Doctor 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 Phacolin eye drops and cataract surgery in people with Cataract Surgery, run by Zhongshan Ophthalmic Center, 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 4 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: finished, as of the sponsor's last update on 30 Mar 2021. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
annual personal income by work in Chinese Yuan (time frame: 1 year). 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 NCT03020056, which also lists 1 linked publication.
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 30 Mar 2021.