The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients
The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients.
To investigate if the Eye Drop Guide more effective than carefully instructed routine technique for chronic glaucoma patients to self-instill eye drops.
And what factors are associated with the failure of self-instillation eye drops with the Eye Drop Guide?
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The participants are randomized into 2 groups. For group I; the participants will be instructed to use the Eye Drop Guide first while for group II; the participants will be instructed to use the routine self-instillation technique first. The instruction will be given to all participants by the same investigator. The participants are allowed to practice until confidence in the techniques to which they are assigned. The participants then are instructed to use only that technique to instill eye drops in both eyes every day and keep the diary to document the date, time of practice, and number of bottles use in each eye for practice at home. The investigators make a telephone visit at 1 week to remind the practice routine and the follow up schedule. The 2 week follow up will be scheduled to evaluate the self-instillation performance using the techniques to which they are assigned by the VDO recordings under the same setting as Day 1.
After VDO recordings the participants will be switched to receive the other technique with the same instruction as the other group. Allow the same period of practice in the hospital and at home. The investigators again will make a 1-week telephone visit and 2-week follow up after self-practice at home. At week 4 the VDO recordings of self-instillation performance will be taken again under the same setting as previous records.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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Bangkok, Thailand, 10700
- Rekrutierung
- Faculty of Medicine, Siriraj Hospital, Mahidol University
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Kontakt:
- Darin Sakiyalak, MD
- Telefonnummer: 6624198033-4
- E-Mail: darin.sak@mahidol.ac.th
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Hauptermittler:
- Darin Sakiyalak, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Have been diagnosed of chronic glaucoma for 3 months or longer
- Age of 18 years or over
- Self-administer eye drops regularly
Exclusion Criteria:
- Perioperative patients
- Patients who were blind from other diseases
- Patients with ophthalmic conditions that affect the eye drop instillation e.g. nystagmus, ptosis, exophthalmos, enophthalmos, microphthalmos, symblepharon, restrictive ophthalmoplegia
- Patients whose underlying conditions would affect the patient's adherence to the protocol e.g. dementia, psychosis, mental retardation, neurological conditions resulting in tremor or paralysis, rheumatoid arthritis, hand deformities
- Patients who are allergic to artificial tears eye drop
- Patients who are not able to return for the follow-up schedule
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Placebo-Komparator: Routine self-instillation technique
The participants first use the Routine self-instillation technique for two weeks and then switch to the Eye Drop Guide technique for another two weeks.
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For the non-seeing eye (best-corrected visual acuity ≤ 20/400) the participants should insert the bottle in the device before cover the eye then proceed with head tilt and look upward. |
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Experimental: Eye Drop Guide technique
The participants first use the Eye Drop Guide technique for two weeks and then switch to the Routine self-instillation technique for another two weeks.
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For the participants using more than one medication after instilling one bottle the participants should wait 3-5 minutes between administering different medications in the same eye. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide.
Zeitfenster: 1 month
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1 month
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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1. To compare the total number of drops dispensed and time to instill drop between 2 groups.
Zeitfenster: 1 month
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1 month
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2. To identify the factors that associated with failure of using the Eye Drop Guide.
Zeitfenster: 1 month
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1 month
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Darin Sakiyalak, MD, Mahidol University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 440/2555 (EC4)
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