GlaucomaFIPSSNCT02628327
Factors Influencing Patient Satisfaction in a Glaucoma Population
An observational study of Glaucoma, run by Wills Eye at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glaucoma or glaucoma suspect
Who may be able to join
- Age > 18 years; patients who have a scheduled appointment at with a glaucoma specialist at Wills Eye Hospital; diagnosis of glaucoma or glaucoma suspect
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
- 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.
- 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
- To assess the correlations between demographic factors, vision related quality of life, eye disease, and treatments with patient satisfaction survey responses.
Read the detailed 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.
- Conditions
- Glaucoma
- Keywords
- glaucoma care, quality of life, patient satisfaction
- Medical subject headings
- Glaucoma, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma subjects | Survey given to all glaucoma subjects agreening to study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life assessment
Correlate demographic factors to vision related quality of life, eye disease and treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathon Myers, Wills Eye
- Investigators
- Jonathan Myers, MD, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628327
- Sponsor's protocol ID
- 15-496E
- Acronym
- FIPSS
- Status last verified
- Nov 2016
- First submitted
- 6 Aug 2015
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A manuscript has been submitted to the Journal of Medical Quality
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Patient Satisfaction in a Glaucoma Population
- ClinicalTrials.gov ID
- NCT02628327
- Acronym / sponsor ID
- FIPSS / 15-496E
- Conditions
- Glaucoma
- Keywords
- glaucoma care, quality of life, patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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
- To assess the correlations between demographic factors, vision related quality of life, eye disease, and treatments with patient satisfaction survey responses.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma subjects | – | –Survey given to all glaucoma subjects agreening to study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma or glaucoma suspect
Key inclusion criteria (1 listed)
- Age > 18 years; patients who have a scheduled appointment at with a glaucoma specialist at Wills Eye Hospital; diagnosis of glaucoma or glaucoma suspect
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life assessment
Time frame: 6 months
Correlate demographic factors to vision related quality of life, eye disease and treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Individual participant dataSharing planned: Yes. A manuscript has been submitted to the Journal of Medical Quality
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Myers, MD principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2016.