- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00760240
Ability of Patients With Low Vision to Properly Instill Eye Drops
April 23, 2010 updated by: Mid-Atlantic Glaucoma Experts
Objective Evaluation of the Ability of Patients With Decreased Vision or Restricted Visual Fields to Properly Instill Eye Drops
The investigators are interested in seeing how people with low vision (decreased visual acuity or restricted visual fields) instill eye drops into their own eyes.
The investigators hypothesis is that this population will have more difficulty with self-instillation of drops than a better-seeing population.
The investigators aim to explore whatever factors may be involved in preventing this population from getting prescribed eyedrops into their eyes, whether it is more related to visual field or visual acuity.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a study that involves a questionnaire that a study participant fills out, detailing their experience with eyedrops (if any), followed by a video recording of them instilling artificial tears into their worse-seeing eye, with their dominant hand.
Patients must have visual acuity worse than 20/60 in at least one eye, and/or have a recent visual field that demonstrated Hodapp criteria for Moderate or Severe visual field damage.
This is an observational study of how patients with low vision due to either glaucoma or retinal disease instill eyedrops.
Each video will be "graded" by the principal investigator for "success" at instilling eyedrops, and patients will be stratified by their visual acuity or visual field, and whether they have a primary diagnosis of glaucoma or retinal disease.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21209
- Glaucoma Specialists/Retina Care Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients reporting for appointments at outpatients referral practices shared by 2 glaucoma and 3 retina specialists
Description
Inclusion Criteria:
- ETDRS visual acuity 20/60 or worse
Exclusion Criteria:
- Unwilling to participate
- Light perception vision
- No light perception vision
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Glaucoma patients
This is a group of patients with restricted visual fields or ETDRS visual acuity of 20/60 or worse
|
Retina patients
A group of patients with retinal pathology(ARMD, CME, diabetic retinopathy) contributing to their decreased vision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Successful instillation of a single eyedrop onto the surface of the eye
Time Frame: 2 minutes
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
September 25, 2008
First Submitted That Met QC Criteria
September 25, 2008
First Posted (Estimate)
September 26, 2008
Study Record Updates
Last Update Posted (Estimate)
April 26, 2010
Last Update Submitted That Met QC Criteria
April 23, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SI-08-64
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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