NCT02633865

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
883

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

December 9, 2015

Last Update Submit

April 18, 2016

Conditions

Cataract

Keywords

patient characteristics

Outcome Measures

Primary Outcomes (1)

  • Family income of the low-income elderly who underwent free cataract surgery assessed through telephone survey

    9 months after surgery

Secondary Outcomes (1)

  • the education level of the low-income elderly who underwent free cataract surgery through telephone survey

    9 months after surgery

Eligibility Criteria

Age50 Years - 102 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (6)

  • Vision 2020: the cataract challenge. Community Eye Health. 2000;13(34):17-9. No abstract available.

    PMID: 17491949BACKGROUND

  • 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. doi: 10.1186/1472-6963-12-302.

    PMID: 22947369BACKGROUND

  • 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.

    PMID: 18684506BACKGROUND

  • 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. doi: 10.1136/bjo.86.7.723.

    PMID: 12084736BACKGROUND

  • 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.

    PMID: 23107580BACKGROUND

  • Lin 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.

    PMID: 27084286DERIVED

Related Links

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Weirong Chen, M.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

  • Yizhi Liu, M.D.;Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

  • Haotian Lin, M.D.;Ph.D.

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 17, 2015

Study Start

May 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

CN(1)