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Satisfaction After Glaucoma Surgery in Rural China

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ClinicalTrials.gov Identifier: NCT02629237
Recruitment Status : Unknown
Verified December 2015 by Congdon Nathan, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : December 14, 2015
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

Brief Summary:
  1. Investigate degree of postoperative satisfaction in county level hospital glaucoma patients.
  2. Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients.
  3. Investigate the effect factors of postoperative satisfaction.

Condition or disease Intervention/treatment Phase
Glaucoma Other: Multifaceted education Not Applicable

Detailed Description:
Glaucoma is the leading cause of irreversible blindness in China, as elsewhere in the world. In Chinese rural settings, where topical glaucoma medication is unlikely to be a practical and sustainable option, surgery is the primary treatment modality for glaucoma. However, it is known that vision is quite likely to decline in the short to medium term after glaucoma surgery, and there are concerns that dis-satisfaction resulting from such vision changes might lead to negative social marketing, affecting uptake not only of glaucoma surgical care but other eye operations (principally cataract) as well. We propose to test the impact on post-operative satisfaction of a multi-media educational intervention designed to give patients a realistic expectation of their post operative course: glaucoma surgery is being performed NOT to improve vision, but do protect it from future harm, and vision may in fact decline for several weeks post operatively. A randomized controlled design will be used, and subjects undergoing glaucoma surgery will be enrolled at 4 rural county hospitals in rural Guangdong province, and randomized to receive the intervention or usual care. The principal outcome will be subjective satisfaction on a previously-tested questionnaire instrument, administered pre-operatively and post-operatively on two occasions in the first month following surgery. Patients not returning post-operatively to the surgical facility will be contacted by telephone for administration of the questionnaire. Other facility- and patient-related clinical and personal factors expected to influence satisfaction will also be recorded, and adjusted for in all analyses.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Multifaceted Education on Satisfaction After Glaucoma Surgery in Rural China
Study Start Date : October 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Multifaceted education group
Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery.
Other: Multifaceted education
Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery.

No Intervention: control group
Subjects will not be asked to watch education film and not participate in counseling session before and after surgery.



Primary Outcome Measures :
  1. The mean satisfaction score over three follow-up visits [ Time Frame: 1 week, 2 week and 4 week after surgery. ]

    The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at three follow-up visits: 1 week, 2 week and 4 week after surgery and dividing the total by the number of scores. The satisfaction score was 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)



Secondary Outcome Measures :
  1. The rate of willingness to recommend surgery to a friend or relative with glaucoma [ Time Frame: 1 week, 2 week and 4 week after surgery. ]
    The measurement method:questionnaire

  2. Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality [ Time Frame: before surgery ]
  3. Knowledge scores about glaucoma [ Time Frame: before surgery and 1 week, 2 week and 4 week after surgery ]
  4. Intraocular pressure in both groups [ Time Frame: before surgery and 1 week, 2 week and 4 week after surgery ]
    Unit of Intraocular pressure is mmHg.

  5. visual acuity in both groups [ Time Frame: before surgery and 1 week, 2 week and 4 week after surgery ]
    Visual acuity testing use Snellen-based letter charts,such as a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is 0.3)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy

Exclusion Criteria:

  • patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia

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): NCT02629237


Contacts
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Contact: Nathan Congdon, MD,MPH +8602087682342 ncongdon1@gmail.com
Contact: KE YANG, MD,PHD +8613878811144 yangke1978@163.com

Locations
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China, Guangdong
Blindness Preventment and Treatment Department Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Nathan G Congdon, MD,MPH       ncongdon1@gmail.com   
Sub-Investigator: Ke Yang, MD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Nathan Congdon, MD,MPH The Key Laboratory,Zhongshan Ophthalmic Center,Sun Yat-sen University

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Responsible Party: Congdon Nathan, vice directior,Blindness Prevention and Treatment Department, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02629237     History of Changes
Other Study ID Numbers: ZOC-CREST-Satisfaction
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Congdon Nathan, Sun Yat-sen University:
glaucoma surgery
educational intervention
satisfaction
rural

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases