- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05215002
Quality Assurance Via Telephone Interviews After Cataract Surgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
As there is a trend towards shorter hospital stays, an increasing number of patients is leaving the hospital the same day after cataract surgery. There may be questions or complaints after the patients' dismissal after cataract surgery, consequently it might be useful to call patients at the day or one day after surgery in order to ask them about their concerns.
In general, possible complications after cataract surgery are explained to patients already before surgery and patients often receive additional written information. But as patients may still be uncertain whether it would be beneficial to visit a doctor in case of problems, it might be useful to call the patients and if necessary, advise them to see a doctor. During the phone call patients have the opportunity to ask more questions if something still does not seem clear.
For patients who are scheduled for cataract surgery for both eyes, the routine procedure is as follows: if cataract surgery is scheduled for both eyes, in general the surgeries are performed one week apart. Cataract surgery is usually performed under local anaesthesia and the patient can leave the department on the same day. When patients arrive at the department of ophthalmology for the second surgery, doctors evaluate the condition of the eye, operated the week before. After each surgery of each eye patients receive a prescription of topical medication. It is recommended to see the referring ophthalmologist within a week after the procedure. In case of problems or complaints patients are always told to see a doctor immediately. A respective written information is given to the patients.
During this study we plan to call patients, who are scheduled for cataract surgery for both eyes, in the evening of the day of the surgery or one day after the surgery of the first eye and to ask questions about their current condition for quality assessment. When people return for cataract surgery of the second eye, a questionnaire will be handed out to the patients. This questionnaire includes questions concerning problems after surgery of the first eye, visits in outpatint clinics and about their satisfaction with the phone call after the surgery of the first eye.
In this study 200 patients will be included: 100 patients will receive a telephone call (50 in the evening of the day of the surgery, 50 one day after surgery) and 100 patients who will not receive a phone call.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Oliver Findl, MD
- Número de teléfono: 57564 +43 (1) 91021
- Correo electrónico: office@viros.at
Copia de seguridad de contactos de estudio
- Nombre: Manuel Ruiss, MD
- Número de teléfono: 57564 +43 (1) 91021
- Correo electrónico: office@viros.at
Ubicaciones de estudio
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Vienna, Austria, 1140
- Reclutamiento
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
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Contacto:
- Oliver Findl, MD
- Número de teléfono: 57564 +43 (1) 91021
- Correo electrónico: office@viros.at
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Contacto:
- Manuel Ruiss, MSc
- Número de teléfono: 57564 +43 (1) 91021
- Correo electrónico: office@viros.at
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- men and women aged 18 and older
- planned cataract surgery of both eyes
- good knowledge of the german language
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Telephone call
Patient will receive a telephone call in the evening of the day of the surgery or one day after surgery
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Patient will be called in the evening of the day of the surgery or one day after surgery and asked about any complaints
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Experimental: No telephone call
Patient will not receive a telephone call in the evening of the day of the surgery or one day after surgery
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Patient will not be called in the evening of the day of the surgery or one day after surgery and asked about any complaints
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of patients
Periodo de tiempo: 24 months
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The number of patients in group 1 and group 2 seen at the outpatient clinic between surgery of the first and the second eye will be documented
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24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patient's Satisfaction
Periodo de tiempo: 24 months
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Patient's satisfaction with the telephone call after cataract surgery will be assessed with a question asking the patient if she/ he liked the call (5 answering options: very, a little, I don't know, no, absolutely not)
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24 months
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Patient's Symptoms
Periodo de tiempo: 24 months
|
Patient's symptoms after cataract surgery will be assessed during the telephone interview and the questionnaire
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24 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Cat Tel
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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