NCT03958929

Brief Summary

Overall Objective: This study will assess whether an educational video is effective in increasing patient satisfaction with glaucoma surgery.

  1. 1.Investigate the impact of educational interventions on glaucoma patients' surgical satisfaction.
  2. 2.Investigate the post-operative satisfaction of rural glaucoma patients in county hospitals
  3. 3.Investigate the difference in postoperative satisfaction between urban and rural glaucoma patients in urban hospitals
  4. 4.Investigate other factors that influence postoperative glaucoma satisfaction.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
4.4 years until next milestone

Study Start

First participant enrolled

October 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

May 20, 2019

Last Update Submit

April 11, 2023

Conditions

Glaucoma

Keywords

glaucoma surgeryeducational interventionsatisfactionrural

Outcome Measures

Primary Outcomes (1)

  • The mean satisfaction outcome over two follow-up visits

    The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at two follow-up visits: 1 day and 1 week after surgery and dividing the total by the number of scores. The satisfaction score will be 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 day, 1 week

Secondary Outcomes (5)

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

    1 day, 1 week

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

    Baseline (before surgery)

  • Knowledge scores about glaucoma

    Baseline (before surgery); 1 day and 1 week after surgery

  • Intraocular pressure in both groups

    Baseline (before surgery); 1 day and 1 week after surgery

  • visual acuity in both groups

    Baseline (before surgery); 1 day and 1 week after surgery

Study Arms (2)

Education group

EXPERIMENTAL

Subjects will be asked to watch a 5-10 min education film two times (pre-op one day and post-op one day).

Other: Educational Video

Control group

NO INTERVENTION

Standard patient procedure that includes a pre-operative discussion with an ophthalmologist about glaucoma surgery, during which the surgeon gains the patient's informed consent. Subjects will not be asked to watch education film..

Interventions

Educational VideoOTHER

The film follows the journey of an elderly patient scheduled to undergo glaucoma surgery, beginning with a face-to-face Q\&A health session with an eye doctor. After surgery, the patient talks about his post-operative eyesight and discusses the benefits of early diagnosis and glaucoma surgery for treatment with his community.

Education group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Eye Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Conditions

GlaucomaPersonal Satisfaction

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesBehavior

Study Officials

  • Nathan Congdon, MD,MPH

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

    PRINCIPAL INVESTIGATOR

  • Yuanbo Liang, MD, PhD

    The Eye Hospital, Wenzhou Medical 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
Principal Investigator

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 22, 2019

Study Start

October 10, 2023

Primary Completion

January 10, 2024

Study Completion

January 30, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)