We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-operative Satisfaction With Glaucoma Surgery Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Congdon Nathan, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01726569
First Posted: November 15, 2012
Last Update Posted: April 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • postoperative satisfaction rate in both group [ Time Frame: after surgery up to 6 weeks ]
    the rate of satisfaction


Secondary Outcome Measures:
  • knowledge about glaucoma [ Time Frame: before surgery and after surgey 1 week and 6 weeks ]
    the knowledge about glaucoma scores

  • willingness to recommend surgery [ Time Frame: after surgery 1 week and 6 weeks ]
    The rate of willingness to recommend surgery

  • personality in both groups [ Time Frame: Baseline (before surgery) ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 10, 2012
First Posted: November 15, 2012
Last Update Posted: April 11, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases