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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00760240
Other study ID # SI-08-64
Secondary ID
Status Completed
Phase N/A
First received September 25, 2008
Last updated April 23, 2010
Start date September 2008
Est. completion date September 2009

Study information

Verified date April 2010
Source Mid-Atlantic Glaucoma Experts
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ETDRS visual acuity 20/60 or worse

Exclusion Criteria:

- Unwilling to participate

- Light perception vision

- No light perception vision

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Glaucoma Specialists/Retina Care Center Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Mid-Atlantic Glaucoma Experts

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful instillation of a single eyedrop onto the surface of the eye 2 minutes No
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