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?
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
-
Bangkok, Tailândia, 10700
- Recrutamento
- Faculty of Medicine, Siriraj Hospital, Mahidol University
-
Contato:
- Darin Sakiyalak, MD
- Número de telefone: 6624198033-4
- E-mail: darin.sak@mahidol.ac.th
-
Investigador principal:
- Darin Sakiyalak, MD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: 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.
|
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. |
|
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.
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
To compare the success rate of self-instillation eye drops between carefully instructed routine technique and the use of Eye Drop Guide.
Prazo: 1 month
|
1 month
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
1. To compare the total number of drops dispensed and time to instill drop between 2 groups.
Prazo: 1 month
|
1 month
|
|
2. To identify the factors that associated with failure of using the Eye Drop Guide.
Prazo: 1 month
|
1 month
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Darin Sakiyalak, MD, Mahidol university
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 440/2555 (EC4)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .