Ability of Patients With Low Vision to Properly Instill Eye Drops

This study has been completed.

Sponsor:

Information provided by:

Mid-Atlantic Glaucoma Experts

ClinicalTrials.gov Identifier:

NCT00760240

First received: September 25, 2008

Last updated: April 23, 2010

Last verified: April 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	September 25, 2008
Last Updated Date	April 23, 2010
Start Date ^ICMJE	September 2008
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 25, 2008)	Successful instillation of a single eyedrop onto the surface of the eye [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00760240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ability of Patients With Low Vision to Properly Instill Eye Drops
Official Title ^ICMJE	Objective Evaluation of the Ability of Patients With Decreased Vision or Restricted Visual Fields to Properly Instill Eye Drops
Brief 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.
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 ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients reporting for appointments at outpatients referral practices shared by 2 glaucoma and 3 retina specialists
Condition ^ICMJE	Glaucoma Retinal Pathology
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	200
Completion Date	September 2009
Primary Completion Date	September 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: ETDRS visual acuity 20/60 or worse Exclusion Criteria: Unwilling to participate Light perception vision No light perception vision
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00760240
Other Study ID Numbers ^ICMJE	SI-08-64
Has Data Monitoring Committee	No
Responsible Party	Amy L Hennessy, Mid-Atlantic Glaucoma Experts
Study Sponsor ^ICMJE	Mid-Atlantic Glaucoma Experts
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mid-Atlantic Glaucoma Experts
Verification Date	April 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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