NCT03125850

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

April 16, 2017

Last Update Submit

July 22, 2020

Conditions

Keywords

knowledgepsychology

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

day-ward group

EXPERIMENTAL
Other: randomized to day ward

inpatient group

ACTIVE COMPARATOR
Other: randomized to inpaitent

Interventions

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

day-ward group

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

inpatient group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patient with mental disorder;
  • 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;
  • Patient with monocular blindness;
  • Axial length≤20 mm;
  • With other serious eye diseases;
  • Neurologic diseases that could affect the visual field;
  • months prior to research to participate in any clinical study;
  • Researchers think not suitable to participate in this clinical trial subjects;
  • Refused to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-San Univerdity

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Mingkai Lin, MD

    Zhongshan Ophthalmic Center, Sun Yat-San University

    STUDY CHAIR

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
chief physician

Study Record Dates

First Submitted

April 16, 2017

First Posted

April 24, 2017

Study Start

August 10, 2017

Primary Completion

December 10, 2017

Study Completion

January 10, 2018

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

No.

Locations