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
  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.


Condition
Glaucoma
Retinal Pathology

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Objective Evaluation of the Ability of Patients With Decreased Vision or Restricted Visual Fields to Properly Instill Eye Drops

Resource links provided by NLM:


Further study details as provided by Mid-Atlantic Glaucoma Experts:

Primary Outcome Measures:
  • Successful instillation of a single eyedrop onto the surface of the eye [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients reporting for appointments at outpatients referral practices shared by 2 glaucoma and 3 retina specialists

Criteria

Inclusion Criteria:

  • ETDRS visual acuity 20/60 or worse

Exclusion Criteria:

  • Unwilling to participate
  • Light perception vision
  • No light perception vision
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760240

Locations
United States, Maryland
Glaucoma Specialists/Retina Care Center
Baltimore, Maryland, United States, 21209
Sponsors and Collaborators
Mid-Atlantic Glaucoma Experts
  More Information

No publications provided

Responsible Party: Amy L Hennessy, Mid-Atlantic Glaucoma Experts
ClinicalTrials.gov Identifier: NCT00760240     History of Changes
Other Study ID Numbers: SI-08-64
Study First Received: September 25, 2008
Last Updated: April 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mid-Atlantic Glaucoma Experts:
compliance
eyedrop instillation
How patients with low vision due to glaucoma or retinal pathology instill eyedrops into their own eyes.

Additional relevant MeSH terms:
Glaucoma
Vision, Low
Ocular Hypertension
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Tetrahydrozoline
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 26, 2014