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Post-operative Satisfaction With Glaucoma Surgery Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01726569
First received: November 10, 2012
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose
  1. Investigate degree of postoperative satisfaction in county level hospital glaucoma patients.
  2. Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients.
  3. Investigate the effect factors of postoperative satisfaction.

Condition Intervention
Glaucoma
 Behavioral: film and trained counseling
Other: traditional counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Trial of the Impact of Multifaceted Education on Post-operative Satisfaction With Glaucoma Surgery in Rural China

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • postoperative satisfaction rate in both group [ Time Frame: after surgery up to 6 weeks ] [ Designated as safety issue: No ]
    the rate of satisfaction


Secondary Outcome Measures:
  • knowledge about glaucoma [ Time Frame: before surgery and after surgey 1 week and 6 weeks ] [ Designated as safety issue: No ]
    the knowledge about glaucoma scores

  • willingness to recommend surgery [ Time Frame: after surgery 1 week and 6 weeks ] [ Designated as safety issue: No ]
    The rate of willingness to recommend surgery

  • personality in both groups [ Time Frame: Baseline (before surgery) ] [ Designated as safety issue: No ]
    use Eysenck Personality Questionnaire-Revised Short Scale for Chinese(EPQ_RSC) access glaucoma patients personality

  • intraocular pressure and visual acuity in both groups [ Time Frame: before surgery and after surgery 1week and 6 weeks ] [ Designated as safety issue: No ]
    intraocular pressure and visual acuity in both groups


Estimated Enrollment: 356
Study Start Date: December 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: film and trained counseling
Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session and follow up counseling after operation 1 week and 6 weeks
 Behavioral: film and trained counseling
Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session.
Other: traditional counseling
Subjects will be not participate or participate in a pre-operative/post-operative counseling session with a rural hospital's doctor/nurse as usual traditional methods.
traditional counseling
Subjects will be participate or not participate in pre-operative counseling and/or post-operative counseling with a rural hospital's doctor/nurse.
 Other: traditional counseling
Subjects will be not participate or participate in a pre-operative/post-operative counseling session with a rural hospital's doctor/nurse as usual traditional methods.

Detailed Description:

Glaucoma is the leading cause irreversible blindness worldwide, but only less than 10% glaucoma patients were diagnosed in the country of Asia areas. In the country of China, patients who are low educational level and less known acknowledgement and information have less known glaucoma. In the help of the government and some international non-governmental organizations(NGOs), a lot of people in the country know the cataract, and the operability of cataract is increase. Because vision loss usually development after operation for glaucoma. If patients did not understand this, they may be not only do not accept operation, but also affect operability of cataract. We hope the educational intervention for glaucoma can increase the degree of satisfaction in glaucoma patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy

Exclusion Criteria:

  • patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726569

Locations
China, Guangdong
Sun Yat-sen University
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Nathan Congdon, MD,MPH Zhongshan Ophthalmic Center,Sun Yat-sen University;ORBIS
  More Information

No publications provided

Responsible Party: Congdon Nathan, Guangdong Educational Intervention for Rural Glaucoma surgical patient, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01726569     History of Changes
Other Study ID Numbers: ZOC-CREST1
Study First Received: November 10, 2012
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board
China: Ethics Committee

Keywords provided by Sun Yat-sen University:
glaucoma
educational intervention
post-operative satisfaction
knowledges

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013