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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01719809
Recruitment Status : Terminated (Enrollment Goals not met)
First Posted : November 1, 2012
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):
Adam C. LePosa, Robin, Alan L., M.D.

Brief Summary:

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 or disease
Glaucoma Ocular Hypertension

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Other
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
Study Start Date : October 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Primary Outcome Measures :
  1. Ability to administer an eye drop according to our criteria, as outlined in our study summary. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Private Ophthalmology Office (Specialty-Glaucoma)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01719809

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United States, Maryland
Alan L. Robin, MD, PA
Baltimore, Maryland, United States, 21209
Sponsors and Collaborators
Robin, Alan L., M.D.
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Principal Investigator: Adam C LePosa, OD Alan L. Robin, MD, PA
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Responsible Party: Adam C. LePosa, Adam C. LePosa, O.D, Robin, Alan L., M.D. Identifier: NCT01719809    
Other Study ID Numbers: ALR 0054
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Keywords provided by Adam C. LePosa, Robin, Alan L., M.D.:
Eye Drop
Eye Drop Technique
Instilling Eye Drops
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases