Glaucoma Eye Drop Instillation: Impact of Education

NCT01416415 | Terminated

• 1 other identifier: NU 00051931
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. The investigators predict that the educational intervention will have a positive impact on the efficacy, safety, and efficiency with which patients administer their eye drops.

Conditions

Glaucoma, Open-Angle

Keywords

Glaucoma, Open-Angle; Ophthalmic Solutions, Eye drops; Instructional Films and Videos

Outcome Measures

Primary Outcomes (1)

• Eye drop instillation score

  The eye drop instillation score is a composite score of the efficacy, safety, and efficiency with which the subject instills their eyedrops and is simply a measure of how well the subject administers their eyedrops.

  4 +/- 3 months

Study Arms (2)

Educational intervention

EXPERIMENTAL

The educational intervention arm will contain subjects who will watch a video on proper eye drop instillation technique.

Other: Video education on proper eye drop instillation technique

Attention placebo

PLACEBO COMPARATOR

The attention control placebo group will receive an educational intervention that mimics the amount of time and attention received by the treatment group. The video chosen is regarding healthy eating tips.

Other: Placebo video education on healthy eating tips

Interventions

Video education on proper eye drop instillation technique OTHER

The video is approximately seven minutes long and teaches the Robert Ritch method of instilling eye drops.

Educational intervention

Placebo video education on healthy eating tips OTHER

The video is approximately seven minutes long and teaches tips to promote healthy eating.

Attention placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established care with the treating ophthalmologist for at least 6 months
• Diagnosis of open-angle glaucoma or ocular hypertension
• The use of one, two or three self-instilled eye drop medications in one or two eyes
• Age 40-85 years
• Fluency in English
• Best corrected visual acuity (BCVA) of 20/50 or better in each eye

You may not qualify if:

• Presence of moderate to severe cognitive deficits
• Presence of a clinically significant tremor
• Mini Mental Status Exam score ≤ 20

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Related Publications (17)

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  PMID: 19920977 BACKGROUND

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  PMID: 17583352 BACKGROUND

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  PMID: 12049574 BACKGROUND

• The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998 Oct;126(4):498-505. doi: 10.1016/s0002-9394(98)00272-4.

  PMID: 9780094 BACKGROUND

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  PMID: 11713061 BACKGROUND

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  PMID: 16563940 BACKGROUND

• Vakil N. Increasing compliance with long-term therapy: avoiding complications and adverse events. Rev Gastroenterol Disord. 2005;5 Suppl 2:S12-7.

  PMID: 16369223 BACKGROUND

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  PMID: 8484454 BACKGROUND

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  PMID: 15744142 BACKGROUND

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  PMID: 14520147 BACKGROUND

• Rotchford AP, Murphy KM. Compliance with timolol treatment in glaucoma. Eye (Lond). 1998;12 ( Pt 2):234-6. doi: 10.1038/eye.1998.56.

  PMID: 9683946 BACKGROUND

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  PMID: 7651690 BACKGROUND

• Dietlein TS, Jordan JF, Luke C, Schild A, Dinslage S, Krieglstein GK. Self-application of single-use eyedrop containers in an elderly population: comparisons with standard eyedrop bottle and with younger patients. Acta Ophthalmol. 2008 Dec;86(8):856-9. doi: 10.1111/j.1755-3768.2007.01155.x. Epub 2008 May 20.

  PMID: 18494743 BACKGROUND

• Djafari F, Lesk MR, Harasymowycz PJ, Desjardins D, Lachaine J. Determinants of adherence to glaucoma medical therapy in a long-term patient population. J Glaucoma. 2009 Mar;18(3):238-43. doi: 10.1097/IJG.0b013e3181815421.

  PMID: 19295380 BACKGROUND

• Gelb L, Friedman DS, Quigley HA, Lyon DW, Tan J, Kim EE, Zimmerman TJ, Hahn SR. Physician beliefs and behaviors related to glaucoma treatment adherence: the Glaucoma Adherence and Persistency Study. J Glaucoma. 2008 Dec;17(8):690-8. doi: 10.1097/IJG.0b013e31816b3001.

  PMID: 19092468 BACKGROUND

• Friedman DS, Hahn SR, Quigley HA, Kotak S, Kim E, Onofrey M, Eagan C, Mardekian J. Doctor-patient communication in glaucoma care: analysis of videotaped encounters in community-based office practice. Ophthalmology. 2009 Dec;116(12):2277-85.e1-3. doi: 10.1016/j.ophtha.2009.04.052. Epub 2009 Sep 10.

  PMID: 19744715 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Angelo P Tanna, M.D.

  Northwestern University Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman, Department of Ophthalmology and Director, Glaucoma Service

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 15, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)