Post-operative Satisfaction With Glaucoma Surgery Trial

A Randomized Trial of the Impact of Multifaceted Education on Post-operative Satisfaction With Glaucoma Surgery in Rural China

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.

Study Overview

• Status: Withdrawn
• Conditions: Glaucoma
• Intervention / Treatment: Behavioral: film and trained counseling; Other: traditional counseling

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative satisfaction rate in both group	the rate of satisfaction	after surgery up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knowledge about glaucoma	the knowledge about glaucoma scores	before surgery and after surgey 1 week and 6 weeks
willingness to recommend surgery	The rate of willingness to recommend surgery	after surgery 1 week and 6 weeks
personality in both groups	use Eysenck Personality Questionnaire-Revised Short Scale for Chinese(EPQ_RSC) access glaucoma patients personality	Baseline (before surgery)
intraocular pressure and visual acuity in both groups	intraocular pressure and visual acuity in both groups	before surgery and after surgery 1week and 6 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Nathan Congdon, MD,MPH, Zhongshan Ophthalmic Center,Sun Yat-sen University;ORBIS

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: November 10, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (Estimate): November 15, 2012

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 5, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: glaucoma; educational intervention; post-operative satisfaction; knowledges
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: ZOC-CREST1