CataractGUSTONCT01123928
Guangdong Uptake of Surgery Trial
A study testing Video and counseling for cataract patients in people with Cataract, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Video and counseling for cataract patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- traumatic cataract
- inability to give informed consent due to dementia or other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial
The purpose of this study is:
- 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;
- To assess short-term impact of the educational intervention on knowledge about cataract and attitudes toward locally-available surgical services.
Read the 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.
- Conditions
- Cataract
- Being tested
- Video and counseling for cataract patients
- Keywords
- cataract, counseling, surgical uptake, follow-up
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video and counseling for cataract patientsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Counseling | Experimental | Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session. Receives: Behavioral: Video and counseling for cataract patients |
| Non-counseling | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision to Undergo Cataract Surgery (Surgery Acceptance)
Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.
Measured: within 6 months after screening examination
Secondary outcomes (6)
Attendance at Hospital for Pre-operative Examination
Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects.
Measured: within 6 months after screening examination
Knowledge That Cataract Can be Treated
Measured as a percentage of subjects who correctly answer the question in a questionnaire.
Measured: Assessed during day of screening examination
Belief That Surgery Will be Painful
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Measured: Assessed during day of screening examination
Belief That Vision Will Improve "a Lot" Following Surgery
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Measured: Assessed during day of screening examination
Belief That Surgeons at the Hospital Are "Highly Skilled"
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Measured: Assessed during day of screening examination
Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Measured: Assessed during day of screening examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Swarthmore College, Helen Keller International
- Responsible party
- Principal investigator, Congdon Nathan, Sun Yat-sen University
- Investigators
- Nathan Congdon, MD, MPH, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityMingguang He, PHD, MPH, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityDavid Friedman, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123928
- Sponsor's protocol ID
- ZOC-123
- Acronym
- GUSTO
- Status last verified
- Feb 2012
- First submitted
- 12 May 2010
- Last updated
- 3 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17515966Ellwein 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.
PubMed 1904845Liu 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.
PubMed 22789919Barry 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.
PubMed 22661464
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial
- ClinicalTrials.gov ID
- NCT01123928
- Acronym / sponsor ID
- GUSTO / ZOC-123
- Conditions
- Cataract
- Keywords
- cataract, counseling, surgical uptake, follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Swarthmore College, Helen Keller International
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 May 2010 (estimated)
- Results
- Posted 2 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- 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;
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling | Experimental | Behavioral: Video and counseling for cataract patientsSubjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session. |
| Non-counseling | No intervention | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- traumatic cataract
- inability to give informed consent due to dementia or other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video and counseling for cataract patientsIntervention 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. | Behavioural | Counseling |
Primary outcome
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.
6 secondary outcomes
Attendance at Hospital for Pre-operative Examination
Time frame: within 6 months after screening examination
Knowledge That Cataract Can be Treated
Time frame: Assessed during day of screening examination
Belief That Surgery Will be Painful
Time frame: Assessed during day of screening examination
Belief That Vision Will Improve "a Lot" Following Surgery
Time frame: Assessed during day of screening examination
Belief That Surgeons at the Hospital Are "Highly Skilled"
Time frame: Assessed during day of screening examination
Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes
Time frame: Assessed during day of screening examination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17515966Tan L. Increasing the volume of cataract surgery: an experience in rural China. Community Eye Health. 2006 Dec;19(60):61-3. No abstract available.
- Background: PubMed 1904845Ellwein 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.
- Derived from this study: PubMed 22789919Liu 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.
- Derived from this study: PubMed 22661464Barry 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.
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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.
Nathan Congdon, MD, MPH principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Mingguang He, PHD, MPH principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
David Friedman, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and counseling for cataract patients in people with 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 2 inclusion and 2 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 3 Feb 2012. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Decision to Undergo Cataract Surgery (Surgery Acceptance) (time frame: within 6 months after screening examination). 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 NCT01123928, which also lists 4 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 3 Feb 2012.