Expired Study
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Baltimore, Maryland 21209


Purpose:

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 summary:

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.


Criteria:

Inclusion Criteria: - ETDRS visual acuity 20/60 or worse Exclusion Criteria: - Unwilling to participate - Light perception vision - No light perception vision


Study is Available At:


Original ID:

SI-08-64


NCT ID:

NCT00760240


Secondary ID:


Study Acronym:


Brief Title:

Ability of Patients With Low Vision to Properly Instill Eye Drops


Official Title:

Objective Evaluation of the Ability of Patients With Decreased Vision or Restricted Visual Fields to Properly Instill Eye Drops


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mid-Atlantic Glaucoma Experts


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Cross-Sectional


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

200


Enrollment Type:

Anticipated


Study Dates

Start Date:September 2008
Completion Date:September 2009
Completion Type:Actual
Primary Completion Date:September 2009
Primary Completion Type:Actual
Verification Date:April 2010
Last Changed Date:April 23, 2010
First Received Date:September 25, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Successful instillation of a single eyedrop onto the surface of the eye
Time Frame:2 minutes
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Glaucoma patients
Description:This is a group of patients with restricted visual fields or ETDRS visual acuity of 20/60 or worse
Study Arm Type:Other
Arm Name:Retina patients
Description:A group of patients with retinal pathology(ARMD, CME, diabetic retinopathy) contributing to their decreased vision.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mid-Atlantic Glaucoma Experts

Samples and Retentions

Study Population: Patients reporting for appointments at outpatients referral practices shared by 2 glaucoma and 3 retina specialists
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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