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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03125850
Other study ID # Zhongshan OC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 10, 2017
Est. completion date January 10, 2018

Study information

Verified date July 2020
Source Zhongshan Ophthalmic Center, Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date January 10, 2018
Est. primary completion date December 10, 2017
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
randomized to day ward
Participants will be randomized to day-ward group, and will accept routine treatment, care, centralized education of glaucoma knowledge
randomized to inpaitent
Participants will be randomized to day-ward group, and will accept routine treatment, care, centralized education of glaucoma knowledge

Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-San Univerdity Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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