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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02628327
Other study ID # 15-496E
Secondary ID
Status Completed
Phase N/A
First received August 6, 2015
Last updated November 8, 2016
Start date June 2015
Est. completion date June 2016

Study information

Verified date November 2016
Source Wills Eye
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

1. To administer a questionnaire to patients seen by Wills Eye Glaucoma Department physicians at Wills Eye Hospital assessing satisfaction with their office visit, vision related quality of life, and related issues.

2. To collect and de-identify information from each participant's medical chart related to their care including information pertaining to demographics, disease severity, and prior and current treatment

3. To assess the correlations between demographic factors, vision related quality of life, eye disease, and treatments with patient satisfaction survey responses.


Description:

This prospective study aims to recruit up to 250 patients being seen by glaucoma specialists at Wills Eye Hospital. Informed consent will be obtained prior to the office visit. Patients will complete a satisfaction survey with a few additional questions about themselves and their vision. Electronic health records (EHR) will be used to collect race, gender, age, glaucoma diagnosis, current and prior treatments, timing of appointment and care, visual acuity and field data, and distance to patient's home. Additional information captured will include weather, time of day, day of week.

In addition to completing the questionnaire subjects will be asked to provide their name and date of birth. Trained research staff members will use this information to find patients on the EHR system. A research assistant will later abstract information from the patient's EHR. This information will be tagged to the survey by a unique identifier, but all patient identity related information will be removed, including name and date of birth. Patients will be made aware that research staff will be retrieving their protected health information (PHI) for the purpose of this study through the consent form.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date June 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Age > 18 years; patients who have a scheduled appointment at with a glaucoma specialist at Wills Eye Hospital; diagnosis of glaucoma or glaucoma suspect

Exclusion Criteria:

Children under the age of 18; inability to give informed consent; patients who are physically and/or mentally incapable of filling out a paper survey; patients who are not literate in English.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wills Eye Hospital Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life assessment Correlate demographic factors to vision related quality of life, eye disease and treatment 6 months No
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