Clinical trial NCT01123928: Guangdong Uptake of Surgery Trial
Official title: The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract
counseling
surgical uptake
follow-up
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Swarthmore College
name: Helen Keller International
First posted: 2010-05-14
Enrollment: 434
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is:

1. To determine whether an educational intervention designed based on studies in the area is effective in increasing acceptance of surgery and presentation to the hospital, when adjusting for a number of potential determinants of service uptake;
2. To assess short-term impact of the educational intervention on knowledge about cataract and attitudes toward locally-available surgical services.

Detailed description: China is home to the 18% of the world's blind people, an estimated 6.6 million. In China, cataract is the leading cause of blindness. In Guangdong, current counseling measures for patients diagnosed with cataract are minimal and often lack adequate descriptions of what cataract is, what causes cataract, and benefits/risks of surgery. A counseling session for cataract patients and family members, conducted by a trained nurse during outreach screening, may increase subsequent attendance at pre-operative examination, acceptance of cataract surgery, and attendance at follow-up examinations. An integral part of this counseling is a short movie consisting of testimony from a former cataract patient who underwent surgery ("pseudophakic motivator"). The use of pseudophakic motivators have been shown to be effective in increasing surgical uptake. In addition, a previously validated "Barriers Questionnaire" will be used to assess predictors of of hospital attendance, surgery acceptance, and follow-up attendance in the categories of cost, transportation, knowledge, and concerns about quality.

Eligibility criteria: Inclusion Criteria:

* thought by the examiner to have age-related or myopic cataract in one or both eyes
* pinhole-corrected visual acuity less than or equal to 6/18.

Exclusion Criteria:

* traumatic cataract
* inability to give informed consent due to dementia or other reasons.

Primary outcomes:
measure: Decision to Undergo Cataract Surgery (Surgery Acceptance)
timeFrame: within 6 months after screening examination
Secondary outcomes:
measure: Attendance at Hospital for Pre-operative Examination
timeFrame: within 6 months after screening examination
measure: Knowledge That Cataract Can be Treated
timeFrame: Assessed during day of screening examination
measure: Belief That Surgery Will be Painful
timeFrame: Assessed during day of screening examination
measure: Belief That Vision Will Improve "a Lot" Following Surgery
timeFrame: Assessed during day of screening examination
measure: Belief That Surgeons at the Hospital Are "Highly Skilled"
timeFrame: Assessed during day of screening examination
measure: Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes
timeFrame: Assessed during day of screening examination
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Nathan Congdon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Mingguang He, PHD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: David Friedman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan L. Increasing the volume of cataract surgery: an experience in rural China. Community Eye Health. 2006 Dec;19(60):61-3. No abstract available.
citation: Ellwein LB, Lepkowski JM, Thulasiraj RD, Brilliant GE. The cost effectiveness of strategies to reduce barriers to cataract surgery. The Operations Research Group. Int Ophthalmol. 1991 May;15(3):175-83. doi: 10.1007/BF00153924.
citation: Liu T, Congdon N, Yan X, Jin L, Wu Y, Friedman D, He M. A randomized, controlled trial of an intervention promoting cataract surgery acceptance in rural China: the Guangzhou Uptake of Surgery Trial (GUSTO). Invest Ophthalmol Vis Sci. 2012 Aug 13;53(9):5271-8. doi: 10.1167/iovs.12-9798.
citation: Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536.