Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients

10 oktober 2012 bijgewerkt door: Mahidol University

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?

Studie Overzicht

Toestand

Onbekend

Conditie

Eye Drops Self-instillation

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

Fase

Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Thailand
- - Bangkok, Thailand, 10700
    - Werving
    - Faculty of medicine, Siriraj hospital, Mahidol university
    - Contact:
      
      Darin Sakiyalak, MD
      
      Telefoonnummer: 6624198033-4
      
      E-mail: darin.sak@mahidol.ac.th
    - Hoofdonderzoeker:
      
      Darin Sakiyalak, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Gerandomiseerd
Interventioneel model: Crossover-opdracht
Masker: Enkel

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Placebo-vergelijker: 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.	Apparaat: Eye Drop Guide technique Wash the hands. Shake and then uncap the bottle. Hold the bottle between the thumb, index, and/or middle finger of the dominant hand. Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers. Then place the upper lip down to cover the whole orbital rim area. Tilt the head back if seated or standing. Insert the bottle in the device all the way. Hold the bottle gently. Look upward. Squeeze the bottle one drop at a time until feel one drop instilled into the eye. Close the eye 2-3 minutes. 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.
Experimenteel: 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.	Gedragsmatig: Routine self-instillation technique Wash the hands. Shake and then uncap the bottle. Hold the bottle between the thumb, index, and/or middle finger of the dominant hand. Lie down or tilt the head back if seated or standing. Using the other hand, pull the lower lid down. Hold the bottle over the eye and look up. Squeeze the bottle one drop at a time until feel one drop instilled into the eye. Close the eye 2-3 minutes. 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.

Deelnemersgroep / Arm

Interventie / Behandeling

Placebo-vergelijker: 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.

Apparaat: Eye Drop Guide technique

Wash the hands.
Shake and then uncap the bottle.
Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers.
Then place the upper lip down to cover the whole orbital rim area.
Tilt the head back if seated or standing.
Insert the bottle in the device all the way. Hold the bottle gently.
Look upward.
Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
Close the eye 2-3 minutes.

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.

Experimenteel: 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.

Gedragsmatig: Routine self-instillation technique

Wash the hands.
Shake and then uncap the bottle.
Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
Lie down or tilt the head back if seated or standing.
Using the other hand, pull the lower lid down.
Hold the bottle over the eye and look up.
Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
Close the eye 2-3 minutes.

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide. Tijdsspanne: 1 month	1 month

Secundaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
1. To compare the total number of drops dispensed and time to instill drop between 2 groups. Tijdsspanne: 1 month	1 month
2. To identify the factors that associated with failure of using the Eye Drop Guide. Tijdsspanne: 1 month	1 month

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mahidol University

Onderzoekers

Hoofdonderzoeker: Darin Sakiyalak, MD, Mahidol University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2012

Primaire voltooiing (Verwacht)

1 februari 2013

Studie voltooiing (Verwacht)

1 april 2013

Studieregistratiedata

Eerst ingediend

8 oktober 2012

Eerst ingediend dat voldeed aan de QC-criteria

10 oktober 2012

Eerst geplaatst (Schatting)

11 oktober 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

11 oktober 2012

Laatste update ingediend die voldeed aan QC-criteria

10 oktober 2012

Laatst geverifieerd

1 oktober 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

eye drops self-instillation

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

440/2555 (EC4)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients