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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02633865
Other study ID # CCPMOH2010-China11
Secondary ID
Status Completed
Phase N/A
First received December 9, 2015
Last updated April 18, 2016
Start date May 2012
Est. completion date August 2014

Study information

Verified date April 2016
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 883
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 102 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Patients with severe eye diseases and bad general condition were excluded.

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhognshan 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 (5)

Liang 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. — View Citation

Vision 2020: the cataract challenge. Community Eye Health. 2000;13(34):17-9. — View Citation

Wang 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. — View Citation

Xu 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. — View Citation

Zhang 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Family income of the low-income elderly who underwent free cataract surgery assessed through telephone survey 9 months after surgery No
Secondary the education level of the low-income elderly who underwent free cataract surgery through telephone survey 9 months after surgery No
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