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Study of Hospitalization of Patients in Day and Inpatient Glaucoma Wards in Zhongshan Ophthalmic Center

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ClinicalTrials.gov Identifier: NCT03125850
Recruitment Status : Not yet recruiting
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Mingkai Lin, Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary:
This study will compare the glaucoma day-ward patients' efficacy with inpatients by evaluating the glaucoma knowledge, psychology, effect of surgery and complications , 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.

Condition or disease Intervention/treatment Phase
Glaucoma Other: routine treatment, care, education of day-ward Other: routine treatment, care, education of inpatient Not Applicable

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 whole effect of the glaucoma day-ward patients by comparing to the inpatients. The whole effect will be assessed by the following indexes, intraocular pressure, mean defect, complications, psychology, glaucoma knowledge. The metal status will be assessed by The hospital anxiety and depression scale.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Study of Hospitalization of Patients in Day and Inpatient Glaucoma Wards in Zhongshan Ophthalmic Center
Estimated Study Start Date : April 27, 2017
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: day-ward group Other: routine treatment, care, education of day-ward
routine treatment, care, centralized education of glaucoma knowledge by nurse after admission

Active Comparator: inpatient group Other: routine treatment, care, education of inpatient
routine treatment, care, centralized education of glaucoma knowledge by nurse after admission




Primary Outcome Measures :
  1. Change of intra-ocular tension(IOP) [ Time Frame: at baseline and the first day after operation ]
    The IOP will be measured by Goldmann tonometer


Secondary Outcome Measures :
  1. Change of depression and anxiety score [ Time Frame: at baseline and 1 hour before discharge ]
    The depression and anxiety score will be measured by The hospital anxiety and depression scale

  2. Complications [ Time Frame: the first day after operation ]
    Complications include shallow anterior chamber, cataract,endophthalmitis, retina detachment,etc.


Other Outcome Measures:
  1. Change of awareness score [ Time Frame: at baseline and 1 hour before discharge ]
    The awareness sore will be measured by Gray Glaucoma Knowledge Questionnaire



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125850


Contacts
Contact: Xi Qin 8613560486730 qinxi@mail2.sysu.edu.cn

Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party: Mingkai Lin, chief physician, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03125850     History of Changes
Other Study ID Numbers: Zhongshan OC
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mingkai Lin, Zhongshan Ophthalmic Center, Sun Yat-sen University:
day-ward
inpatient

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases