CataractNCT02633865
Patient Participation in Free Cataract Surgery
An observational study of Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
Age-related cataracts remain the leading cause of treatable blindness in China. The prevalence of cataract blindness continues to climb due to the expanding elderly subpopulation. Read more about this study
- Who is it for?
- Ages 50 to 102 years
- Conditions the study is for
- Cataract
- How many people
- 883 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Aug 2014
- How long will I take part?
- 9 Months
- Phase
- Observational
- 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 to 102 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A free cataract surgery program was jointly initiated by the People's Government of Guangzhou Municipality, the Bureau of Civil Affairs of Guangzhou Municipality, and the ZOC in May 2012. Guangzhou citizens aged ≥50 years with low income who relied on social subsidies were candidates for this activity.
Who may be able to join
- All participants with presenting visual acuity (PVA), unaided visual acuity or aided visual acuity with walk-in optical correction5 of ≤20/50 in either eye.
Who cannot join
- Patients with severe eye diseases and bad general condition were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Patient Participation in Free Cataract Surgery: The Low-income Elderly in Urban China
Age-related cataracts remain the leading cause of treatable blindness in China. The prevalence of cataract blindness continues to climb due to the expanding elderly subpopulation. Surgery is the only available treatment; however, the cataract surgical rate (CSR) in China remains relatively low relative to affluent countries or certain developing areas. Studies have reported that the primary barrier to cataract surgery is financial difficulty, and this challenge could be efficiently addressed by reducing the surgical fee or providing free cataract surgery. However, the prices, availability and affordability of medicines or medical services to the poor in China require further improvement. Although a host of free cataract screening and surgery programs have been widely implemented in rural areas of China, free cataract surgery programs have rarely been implemented in financially-challenged urban China. Even in Guangzhou, one of the largest metropolises in China, many low-income cataract patients, a neglected cohort, continue to need cataract surgery. A program titled "care for your eyes, lighten your life", jointly sponsored by the People's Government of Guangzhou Municipality, the Bureau of Civil Affairs of Guangzhou Municipality, and the Zhongshan Ophthalmic Center (ZOC), has been initiated in Guangzhou to implement a program of free clinics in parks and free cataract surgery targeting the impoverished population living in urban China in 2012. After 3 years' exploration, the management mode of this program has been perfected, and approximately 4000 cataract surgeries had been performed on the low-income elderly.
Although there are a large number of poor communities throughout the country, free cataract surgery programs in poor urban China are restricted to several metropolises due to limited medical resources and social overlook. Fully understanding patient satisfaction regarding the free cataract surgery program and understanding the patient characteristics of this special, neglected community may contribute to the improvement and the further expansion of the management mode of free cataract surgery programs.
Read the detailed description
Age-related cataracts remain the leading cause of treatable blindness in China. The prevalence of cataract blindness continues to climb due to the expanding elderly subpopulation. Surgery is the only available treatment; however, the cataract surgical rate (CSR) in China remains relatively low (772 cases per million per year) relative to affluent countries (6000 cases per million per year) or certain developing areas (2672 cases per million per year). Studies have reported that the primary barrier to cataract surgery is financial difficulty, and this challenge could be efficiently addressed by reducing the surgical fee1 or providing free cataract surgery. However, the prices, availability and affordability of medicines or medical services to the poor in China require further improvement, according to the standards developed by the World Health Organization (WHO) in collaboration with Health Action International (HAI) in May 2003. Although a host of free cataract screening and surgery programs have been widely implemented in rural areas of China in conjunction with a new national healthcare reform officially launched in 2009 to tackle high medical expenses, including promoting free medical treatments, free cataract surgery programs have rarely been implemented in financially-challenged urban China. Even in Guangzhou, one of the largest metropolises in China, many low-income cataract patients, a neglected cohort, continue to need cataract surgery. A program titled "care for your eyes, lighten your life", jointly sponsored by the People's Government of Guangzhou Municipality, the Bureau of Civil Affairs of Guangzhou Municipality, and the Zhongshan Ophthalmic Center (ZOC), has been initiated in Guangzhou to implement a program of free clinics in parks and free cataract surgery targeting the impoverished population living in urban China in 2012.13 After 3 years' exploration, the management mode of this program has been perfected, and approximately 4000 cataract surgeries had been performed on the low-income elderly.
Although there are a large number of poor communities throughout the country, free cataract surgery programs in poor urban China are restricted to several metropolises due to limited medical resources and social overlook. Fully understanding patient satisfaction regarding the free cataract surgery program and understanding the patient characteristics of this special, neglected community may contribute to the improvement and the further expansion of the management mode of free cataract surgery programs. In this telephone survey, the investigators aimed to investigate the characteristics of the low-income patients undergoing free cataract surgery, including patient demographics, patient resource, health conditions, reasons for choosing the free surgery, and overall evaluation of the free cataract surgery program.
- Conditions
- Cataract
- Keywords
- patient characteristics
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Family income of the low-income elderly who underwent free cataract surgery assessed through telephone survey
Measured: 9 months after surgery
Secondary outcomes (1)
the education level of the low-income elderly who underwent free cataract surgery through telephone survey
Measured: 9 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startMay 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 883 participants (actual)
- Target duration
- 9 Months
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
- Weirong Chen, M.D., Study director, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D.;Ph.D., Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityHaotian Lin, M.D.;Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633865
- Sponsor's protocol ID
- CCPMOH2010-China11
- Status last verified
- Apr 2016
- First submitted
- 9 Dec 2015
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vision 2020: the cataract challenge. Community Eye Health. 2000;13(34):17-9. No abstract available.
PubMed 17491949Wang Y, Wang J, Maitland E, Zhao Y, Nicholas S, Lu M. Growing old before growing rich: inequality in health service utilization among the mid-aged and elderly in Gansu and Zhejiang Provinces, China. BMC Health Serv Res. 2012 Sep 4;12:302. doi: 10.1186/1472-6963-12-302.
PubMed 22947369Liang YB, Friedman DS, Wong TY, Zhan SY, Sun LP, Wang JJ, Duan XR, Yang XH, Wang FH, Zhou Q, Wang NL; Handan Eye Study Group. Prevalence and causes of low vision and blindness in a rural chinese adult population: the Handan Eye Study. Ophthalmology. 2008 Nov;115(11):1965-72. doi: 10.1016/j.ophtha.2008.05.030. Epub 2008 Aug 5.
PubMed 18684506Xu J, Zhu S, Li S, Pizzarello L. Models for improving cataract surgical rates in southern China. Br J Ophthalmol. 2002 Jul;86(7):723-4. doi: 10.1136/bjo.86.7.723.
PubMed 12084736Zhang XJ, Liang YB, Liu YP, Jhanji V, Musch DC, Peng Y, Zheng CR, Zhang HX, Chen P, Tang X, Lam DS. Implementation of a free cataract surgery program in rural China: a community-based randomized interventional study. Ophthalmology. 2013 Feb;120(2):260-5. doi: 10.1016/j.ophtha.2012.07.087. Epub 2012 Oct 27.
PubMed 23107580Lin H, Lin D, Long E, Jiang H, Qu B, Tang J, Lin Y, Chen J, Wu X, Lin Z, Li X, Liu Z, Zhang B, Chen H, Tan X, Luo L, Liu Y, Chen W. Patient participation in free cataract surgery: a cross-sectional study of the low-income elderly in urban China. BMJ Open. 2016 Apr 15;6(4):e011061. doi: 10.1136/bmjopen-2016-011061.
PubMed 27084286
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Participation in Free Cataract Surgery: The Low-income Elderly in Urban China
- ClinicalTrials.gov ID
- NCT02633865
- Acronym / sponsor ID
- CCPMOH2010-China11
- Conditions
- Cataract
- Keywords
- patient characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 883 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- May 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Dec 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.
Age-related cataracts remain the leading cause of treatable blindness in China. The prevalence of cataract blindness continues to climb due to the expanding elderly subpopulation. Surgery is the only available treatment; however, the cataract surgical rate (CSR) in China remains relatively low relative to affluent countries or certain developing areas. Studies have reported that the primary barrier to cataract surgery is financial difficulty, and this challenge could be efficiently addressed by reducing the surgical fee or providing free cataract surgery. However, the prices, availability and affordability of medicines or medical services to the poor in China require further improvement. Although a host of free cataract screening and surgery programs have been widely implemented in rural areas of China, free cataract surgery programs have rarely been implemented in financially-challenged urban China. Even in Guangzhou, one of the largest metropolises in China, many low-income cataract patients, a neglected cohort, continue to need cataract surgery. A program titled "care for your eyes, lighten your life", jointly sponsored by the People's Government of Guangzhou Municipality, the Bureau of Civil Affairs of Guangzhou Municipality, and the Zhongshan Ophthalmic Center (ZOC), has been initiated in Guangzhou to implement a program of free clinics in parks and free cataract surgery targeting the impoverished population living in urban China in 2012. After 3 years' exploration, the management mode of this program has been perfected, and approximately 4000 cataract surgeries had been performed on the low-income elderly.
Although there are a large number of poor communities throughout the country, free cataract surgery programs in poor urban China are restricted to several metropolises due to limited medical resources and social overlook. Fully understanding patient satisfaction regarding the free cataract surgery program and understanding the patient characteristics of this special, neglected community may contribute to the improvement and the further expansion of the management mode of free cataract surgery programs.
Detailed description
Age-related cataracts remain the leading cause of treatable blindness in China. The prevalence of cataract blindness continues to climb due to the expanding elderly subpopulation. Surgery is the only available treatment; however, the cataract surgical rate (CSR) in China remains relatively low (772 cases per million per year) relative to affluent countries (6000 cases per million per year) or certain developing areas (2672 cases per million per year). Studies have reported that the primary barrier to cataract surgery is financial difficulty, and this challenge could be efficiently addressed by reducing the surgical fee1 or providing free cataract surgery. However, the prices, availability and affordability of medicines or medical services to the poor in China require further improvement, according to the standards developed by the World Health Organization (WHO) in collaboration with Health Action International (HAI) in May 2003. Although a host of free cataract screening and surgery programs have been widely implemented in rural areas of China in conjunction with a new national healthcare reform officially launched in 2009 to tackle high medical expenses, including promoting free medical treatments, free cataract surgery programs have rarely been implemented in financially-challenged urban China. Even in Guangzhou, one of the largest metropolises in China, many low-income cataract patients, a neglected cohort, continue to need cataract surgery. A program titled "care for your eyes, lighten your life", jointly sponsored by the People's Government of Guangzhou Municipality, the Bureau of Civil Affairs of Guangzhou Municipality, and the Zhongshan Ophthalmic Center (ZOC), has been initiated in Guangzhou to implement a program of free clinics in parks and free cataract surgery targeting the impoverished population living in urban China in 2012.13 After 3 years' exploration, the management mode of this program has been perfected, and approximately 4000 cataract surgeries had been performed on the low-income elderly.
Although there are a large number of poor communities throughout the country, free cataract surgery programs in poor urban China are restricted to several metropolises due to limited medical resources and social overlook. Fully understanding patient satisfaction regarding the free cataract surgery program and understanding the patient characteristics of this special, neglected community may contribute to the improvement and the further expansion of the management mode of free cataract surgery programs. In this telephone survey, the investigators aimed to investigate the characteristics of the low-income patients undergoing free cataract surgery, including patient demographics, patient resource, health conditions, reasons for choosing the free surgery, and overall evaluation of the free cataract surgery program.
Study design
- Time perspective
- Cross-sectional
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 50 to 102 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A free cataract surgery program was jointly initiated by the People's Government of Guangzhou Municipality, the Bureau of Civil Affairs of Guangzhou Municipality, and the ZOC in May 2012. Guangzhou citizens aged ≥50 years with low income who relied on social subsidies were candidates for this activity.
Key inclusion criteria (1 listed)
- All participants with presenting visual acuity (PVA), unaided visual acuity or aided visual acuity with walk-in optical correction5 of ≤20/50 in either eye.
Key exclusion criteria (1 listed)
- Patients with severe eye diseases and bad general condition were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Family income of the low-income elderly who underwent free cataract surgery assessed through telephone survey
Time frame: 9 months after surgery
1 secondary outcome
the education level of the low-income elderly who underwent free cataract surgery through telephone survey
Time frame: 9 months after surgery
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 20 Apr 2016.
- Background: PubMed 17491949Vision 2020: the cataract challenge. Community Eye Health. 2000;13(34):17-9. No abstract available.
- Background: PubMed 22947369Wang Y, Wang J, Maitland E, Zhao Y, Nicholas S, Lu M. Growing old before growing rich: inequality in health service utilization among the mid-aged and elderly in Gansu and Zhejiang Provinces, China. BMC Health Serv Res. 2012 Sep 4;12:302. doi: 10.1186/1472-6963-12-302.
- Background: PubMed 18684506Liang YB, Friedman DS, Wong TY, Zhan SY, Sun LP, Wang JJ, Duan XR, Yang XH, Wang FH, Zhou Q, Wang NL; Handan Eye Study Group. Prevalence and causes of low vision and blindness in a rural chinese adult population: the Handan Eye Study. Ophthalmology. 2008 Nov;115(11):1965-72. doi: 10.1016/j.ophtha.2008.05.030. Epub 2008 Aug 5.
- Background: PubMed 12084736Xu J, Zhu S, Li S, Pizzarello L. Models for improving cataract surgical rates in southern China. Br J Ophthalmol. 2002 Jul;86(7):723-4. doi: 10.1136/bjo.86.7.723.
- Background: PubMed 23107580Zhang XJ, Liang YB, Liu YP, Jhanji V, Musch DC, Peng Y, Zheng CR, Zhang HX, Chen P, Tang X, Lam DS. Implementation of a free cataract surgery program in rural China: a community-based randomized interventional study. Ophthalmology. 2013 Feb;120(2):260-5. doi: 10.1016/j.ophtha.2012.07.087. Epub 2012 Oct 27.
- Derived from this study: PubMed 27084286Lin H, Lin D, Long E, Jiang H, Qu B, Tang J, Lin Y, Chen J, Wu X, Lin Z, Li X, Liu Z, Zhang B, Chen H, Tan X, Luo L, Liu Y, Chen W. Patient participation in free cataract surgery: a cross-sectional study of the low-income elderly in urban China. BMJ Open. 2016 Apr 15;6(4):e011061. doi: 10.1136/bmjopen-2016-011061.
- 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.
Weirong Chen, M.D. study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D.;Ph.D. study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Haotian Lin, M.D.;Ph.D. principal investigator
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?
An observational study of Cataract, 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 1 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 20 Apr 2016. 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?
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?
Family income of the low-income elderly who underwent free cataract surgery assessed through telephone survey (time frame: 9 months after surgery). 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 NCT02633865, which also lists 6 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 20 Apr 2016.