Post-operative Satisfaction With Glaucoma Surgery Trial

Sponsor
Sun Yat-sen University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01726569
Collaborator
(none)
0
1
2
14.9
0

Study Details

Study Description

Brief Summary

  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 or Disease Intervention/Treatment Phase
  • Behavioral: film and trained counseling
  • Other: traditional counseling
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
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
Study Start Date :
Dec 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2013
Anticipated Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. postoperative satisfaction rate in both group [after surgery up to 6 weeks]

    the rate of satisfaction

Secondary Outcome Measures

  1. knowledge about glaucoma [before surgery and after surgey 1 week and 6 weeks]

    the knowledge about glaucoma scores

  2. willingness to recommend surgery [after surgery 1 week and 6 weeks]

    The rate of willingness to recommend surgery

  3. personality in both groups [Baseline (before surgery)]

    use Eysenck Personality Questionnaire-Revised Short Scale for Chinese(EPQ_RSC) access glaucoma patients personality

  4. intraocular pressure and visual acuity in both groups [before surgery and after surgery 1week and 6 weeks]

    intraocular pressure and visual acuity in both groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Congdon Nathan, Guangdong Educational Intervention for Rural Glaucoma surgical patient, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01726569
Other Study ID Numbers:
  • ZOC-CREST1
First Posted:
Nov 15, 2012
Last Update Posted:
Dec 21, 2021
Last Verified:
Dec 1, 2021
Keywords provided by Congdon Nathan, Guangdong Educational Intervention for Rural Glaucoma surgical patient, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2021