An Evaluation of the Ability to Train Established Glaucoma Patients Who Have Difficulty in Drop Instillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Robin, Alan L., M.D.
Sponsor:
Information provided by (Responsible Party):
Adam C. LePosa, Robin, Alan L., M.D.
ClinicalTrials.gov Identifier:
NCT01719809
First received: October 25, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

This is a prospective, observational, single-center study. Patients with at least 3 months of experience using topical medications for glaucoma and who state that they administer their own eye drops will be recruited. Subjects will be videotaped instilling a sterile artificial eye drop, will be identified at the time of a regularly scheduled exam. If the patient can get a drop onto the eye and also not touch their lids or ocular surface with the eye drop bottle, the subject will be thanked but not enrolled. All other patients who agree to participate will be enrolled. Upon completion of videotaped instillation of an eye drop, each enrolled patient will be shown a video demonstrating an instillation technique and will be given an instructional handout highlighting a proper drop instillation technique. If necessary, an instillation technique will be demonstrated to them by an investigator or trained personnel.

A patient will be identified as properly instilling a drop if they satisfy the following criteia:

They are able to instill one (and only one) drop to the ocular surface or lower fornix without allowing the bottle touch the adnexa, eyelid, eye lashes or eye.

All patients routinely return between 3 and 6 months. At this regularly scheduled visit,the investigator or trained personnel would direct the patient to instill an eye drop into the study eye.Additionally, the short glaucoma self-efficacy questionnaire will be re-administered.

All of the video-recordings of participants' eye drop instillation techniques will be reviewed and assessed using a standard checklist. Their ability to administer an eye drop after training will be compared to baseline.


Condition
Glaucoma
Ocular Hypertension

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Evaluation of the Effect of Training on Eye Drop Administration in Glaucoma Subjects Who Have Difficulties Properly Instilling Eye Drops

Resource links provided by NLM:


Further study details as provided by Robin, Alan L., M.D.:

Primary Outcome Measures:
  • Ability to administer an eye drop according to our criteria, as outlined in our study summary. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Private Ophthalmology Office (Specialty-Glaucoma)

Criteria

Inclusion Criteria:

  • Patients aged 18 years or older
  • Patients currently using topical ocular antihypertensive medications at the time of enrollment in at least one eye, and who have been using these drops consistently for a period of at least three months prior to enrollment.
  • Patients with primary open angle glaucoma, pigmentary glaucoma, exfoliation glaucoma, ocular hypertension, normal-tension glaucoma, neovascular glaucoma, uveitic glaucoma and chronic narrow angle glaucoma.
  • Patients CAN be enrolled even if they have co-existing morbidities such as Parkinson's Disease or arthritis

Exclusion Criteria:

  • Patients who do not instill their own eye drops
  • Patients who are not expected to still be using topical antihypertensive medications at the time of study follow-up
  • Patients with no light perception vision
  • Patients with a history of adverse reaction to artificial tears or any component of artificial tears
  • Patients who have a typical follow-up period of greater than 6 months
  • Patients who have not completed a Humphrey Visual Field C24-2 or C10-2 within 7 months of enrollment or study exit.
  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: NCT01719809

Contacts
Contact: Shamekia R Newton, BS, CCRC 410-377-2422 snewton@glaucomaexpert.com

Locations
United States, Maryland
Alan L. Robin, MD, PA Recruiting
Baltimore, Maryland, United States, 21209
Contact: Shamekia R Newton, BS, CCRC    410-377-2422    snewton@glaucomaexpert.com   
Principal Investigator: Adam C LePosa, OD         
Sub-Investigator: Alan L Robin, MD         
Sponsors and Collaborators
Robin, Alan L., M.D.
Investigators
Principal Investigator: Adam C LePosa, OD Alan L. Robin, MD, PA
  More Information

No publications provided

Responsible Party: Adam C. LePosa, Adam C. LePosa, O.D, Robin, Alan L., M.D.
ClinicalTrials.gov Identifier: NCT01719809     History of Changes
Other Study ID Numbers: ALR 0054
Study First Received: October 25, 2012
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Robin, Alan L., M.D.:
Glaucoma
Eye Drop
Eye Drop Technique
Training
Instilling Eye Drops

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014