Clinical trial NCT01719809: An Evaluation of the Ability to Train Established Glaucoma Patients Who Have Difficulty in Drop Instillation
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Eye Drop
Eye Drop Technique
Training
Instilling Eye Drops
Lead sponsor: Robin, Alan L., M.D.
Sponsor class: INDIV
First posted: 2012-11-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Private Ophthalmology Office (Specialty-Glaucoma)

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.


Eligibility 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.

Primary outcomes:
measure: Ability to administer an eye drop according to our criteria, as outlined in our study summary.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Alan L. Robin, MD, PA
state: Maryland
Study officials:
affiliation: Alan L. Robin, MD, PA
name: Adam C LePosa, OD
role: PRINCIPAL_INVESTIGATOR
References: