Comparative Study of Psychology and Glaucoma Knowledge in Glaucoma Day-ward Patients Inpatients

This study will compare the glaucoma day-ward patients' efficacy with inpatients by evaluating the glaucoma knowledge and psychology , and will analysis the reasons of the differences. Half of participants will receive treatment in day-ward, while the other half will receive treatment in hospital.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Other: randomized to day ward; Other: randomized to inpaitent

Detailed Description

Ophthalmic surgery has short operative time, quick recovery, and small anesthesia risk, making day case surgery the main management mode of ophthalmic surgery. This study will explore the differences of psychology and glaucoma knowledge between glaucoma day-ward patients and the inpatients. The data will be collected by scale on admission and discharge.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Zhongshan Ophthalmic Center, Sun Yat-San Univerdity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is diagnosed with glaucoma;
2. Will receive glaucoma surgery;
3. Voluntary participation in this study;
4. Have enough language comprehension ability;
5. Best corrected visual acuity reach 0.1 or better;
6. Patient or his legal representative has sign the informed consent.

Exclusion Criteria:

1. Patient with mental disorder;
2. There are important viscera function failure or other serious disease, including clinical related coronary artery disease, cardiovascular disease or myocardial infarction into the group of the first six months; serious neurological or psychiatric illness; serious infections; coagulant function abnormality; general active infectious diseases; malignant tumor; serious immune diseases;
3. Patient with monocular blindness;
4. Axial length≤20 mm;
5. With other serious eye diseases;
6. Neurologic diseases that could affect the visual field;
7. 3 months prior to research to participate in any clinical study;
8. Researchers think not suitable to participate in this clinical trial subjects;
9. Refused to sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: day-ward group	Other: randomized to day ward; Participants will be randomized to day-ward group, and will accept routine treatment, care, centralized education of glaucoma knowledge
ACTIVE_COMPARATOR: inpatient group	Other: randomized to inpaitent; Participants will be randomized to day-ward group, and will accept routine treatment, care, centralized education of glaucoma knowledge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of depression and anxiety score	The outcome will be measured by The Hospital Depression and Anxiety Scale (HADS). It consists of two subscales: HDAS-anxiety and HADS-depression. Each item is srored from 0-3, with higher scores indicating a higher level of depression and anxiety. For each of the seven-item subscales, the minimum sum score is 0, and the maximum is 21.	at baseline and 1 hour before discharge
Change of glaucoma knowledge score	The outcome will be measured by The Gray Glaucoma Knowledge Questionaire. This quesionanire has a total maximum score of 17, with higher scores representing better knowledge.	at baseline and 1 hour before discharge

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2017
• Primary Completion (ACTUAL): December 10, 2017
• Study Completion (ACTUAL): January 10, 2018

Study Registration Dates

• First Submitted: April 16, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (ACTUAL): April 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: psychology; knowledge
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: Zhongshan OC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No