- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05215002
Quality Assurance Via Telephone Interviews After Cataract Surgery
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Oliver Findl, MD
- Numéro de téléphone: 57564 +43 (1) 91021
- E-mail: office@viros.at
Sauvegarde des contacts de l'étude
- Nom: Manuel Ruiss, MD
- Numéro de téléphone: 57564 +43 (1) 91021
- E-mail: office@viros.at
Lieux d'étude
-
-
-
Vienna, L'Autriche, 1140
- Recrutement
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
-
Contact:
- Oliver Findl, MD
- Numéro de téléphone: 57564 +43 (1) 91021
- E-mail: office@viros.at
-
Contact:
- Manuel Ruiss, MSc
- Numéro de téléphone: 57564 +43 (1) 91021
- E-mail: office@viros.at
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- men and women aged 18 and older
- planned cataract surgery of both eyes
- good knowledge of the german language
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Telephone call
Patient will receive a telephone call in the evening of the day of the surgery or one day after surgery
|
Patient will be called in the evening of the day of the surgery or one day after surgery and asked about any complaints
|
|
Expérimental: No telephone call
Patient will not receive a telephone call in the evening of the day of the surgery or one day after surgery
|
Patient will not be called in the evening of the day of the surgery or one day after surgery and asked about any complaints
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of patients
Délai: 24 months
|
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
|
24 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient's Satisfaction
Délai: 24 months
|
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)
|
24 months
|
|
Patient's Symptoms
Délai: 24 months
|
Patient's symptoms after cataract surgery will be assessed during the telephone interview and the questionnaire
|
24 months
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Cat Tel
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .