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

10. oktober 2012 opdateret af: 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?

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Thailand
      • Bangkok, Thailand, 10700
        • Rekruttering
        • Faculty of Medicine, Siriraj Hospital, Mahidol University
        • Kontakt:
        • Ledende efterforsker:
          • Darin Sakiyalak, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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.
Enhed: Eye Drop Guide technique
  1. Wash the hands.
  2. Shake and then uncap the bottle.
  3. Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
  4. Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers.
  5. Then place the upper lip down to cover the whole orbital rim area.
  6. Tilt the head back if seated or standing.
  7. Insert the bottle in the device all the way. Hold the bottle gently.
  8. Look upward.
  9. Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
  10. 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.
Eksperimentel: 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.
Adfærdsmæssigt: Routine self-instillation technique
  1. Wash the hands.
  2. Shake and then uncap the bottle.
  3. Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
  4. Lie down or tilt the head back if seated or standing.
  5. Using the other hand, pull the lower lid down.
  6. Hold the bottle over the eye and look up.
  7. Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
  8. 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mahidol University

Efterforskere

  • Ledende efterforsker: Darin Sakiyalak, MD, Mahidol University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Forventet)

1. februar 2013

Studieafslutning (Forventet)

1. april 2013

Datoer for studieregistrering

Først indsendt

8. oktober 2012

Først indsendt, der opfyldte QC-kriterier

10. oktober 2012

Først opslået (Skøn)

11. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 440/2555 (EC4)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Eye Drop Guide technique

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Betingelser

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Placeringer

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