Satisfaction After Glaucoma Surgery in Rural China

NCT02629237 | Withdrawn DMC

• 1 other identifier: ZOC-CREST-Satisfaction
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Investigate degree of postoperative satisfaction in county level hospital glaucoma patients.
2. 2.Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients.
3. 3.Investigate the effect factors of postoperative satisfaction.

Conditions

Glaucoma

Keywords

glaucoma surgery; educational intervention; satisfaction; rural

Outcome Measures

Primary Outcomes (1)

• The mean satisfaction score over three follow-up visits

  The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at three follow-up visits: 1 week, 2 week and 4 week after surgery and dividing the total by the number of scores. The satisfaction score was assessed as a cumulative score. Composite outcome, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency, although such measure may prove challenging for the interpretation of results. (Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA. 2003; 289: 2554-2559)

  1 week, 2 week and 4 week after surgery.

Secondary Outcomes (5)

• The rate of willingness to recommend surgery to a friend or relative with glaucoma

  1 week, 2 week and 4 week after surgery.

• Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality

  before surgery

• Knowledge scores about glaucoma

  before surgery and 1 week, 2 week and 4 week after surgery

• Intraocular pressure in both groups

  before surgery and 1 week, 2 week and 4 week after surgery

• visual acuity in both groups

  before surgery and 1 week, 2 week and 4 week after surgery

Study Arms (2)

Multifaceted education group

EXPERIMENTAL

Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery.

Other: Multifaceted education

control group

NO INTERVENTION

Subjects will not be asked to watch education film and not participate in counseling session before and after surgery.

Interventions

Multifaceted education OTHER

Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery.

Multifaceted education group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Blindness Preventment and Treatment Department

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Glaucoma; Personal Satisfaction

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Behavior

Study Officials

• Nathan Congdon, MD,MPH

  The Key Laboratory,Zhongshan Ophthalmic Center,Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice directior,Blindness Prevention and Treatment Department

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: December 14, 2015
• Study Start: March 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

CN (1)