Skip to main content
OpenTrials
Completed

NCT Number: NCT01123928

Guangdong Uptake of Surgery Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video and counseling for cataract patients

Behavioral

Intervention includes: (1) a 5-10 min video consisting of testimony from a previous cataract patient and a doctor; (2) a 10-15 min pre-operative counseling session with a trained nurse, and (3) a 5 min post-operative counseling session with a trained nurse.

Primary outcomes

  1. Decision to Undergo Cataract Surgery (Surgery Acceptance)

    Time frame: within 6 months after screening examination

    Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.

Secondary outcomes

  1. Attendance at Hospital for Pre-operative Examination

    Time frame: within 6 months after screening examination

    Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects.

  2. Knowledge That Cataract Can be Treated

    Time frame: Assessed during day of screening examination

    Measured as a percentage of subjects who correctly answer the question in a questionnaire.

  3. Belief That Surgery Will be Painful

    Time frame: Assessed during day of screening examination

    Measured as a percentage of subjects who agree with the statement in a questionnaire.

  4. Belief That Vision Will Improve "a Lot" Following Surgery

    Time frame: Assessed during day of screening examination

    Measured as a percentage of subjects who agree with the statement in a questionnaire.

  5. Belief That Surgeons at the Hospital Are "Highly Skilled"

    Time frame: Assessed during day of screening examination

    Measured as a percentage of subjects who agree with the statement in a questionnaire.

  6. Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes

    Time frame: Assessed during day of screening examination

    Measured as a percentage of subjects who agree with the statement in a questionnaire.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Helen Keller International
  • Swarthmore College

Registry information

Official study title

The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial

Acronym: GUSTO

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 14, 2010
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.