Multicentric Observational Study on Quality of Life in Glaucoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT01742104
First received: December 3, 2012
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

The study aims to evaluate the quality of life (QoL) of patients affected by Primary Open-Angle Glaucoma (POAG), using 2 QoL questionnaires:

  1. Glaucoma Symptom Scale (GSS) and
  2. National Eye Institute Visual Function Questionnaire (NEI-VFQ -25). The study will be conducted on patients with well known diagnosis of POAG (transversal phase) and on patients with first diagnosis of POAG (longitudinal phase).

Condition
Primary Open-angle Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Multicentric Observational Clinical Study on Quality of Life in Patients With Glaucoma in Italy

Resource links provided by NLM:


Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • Quality of life questionnaires [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    National Eye Institute Visual Function Questionnaire (NEI-VFQ-25 - Italian Version, Jan 2003) Glaucoma Symptom Scale (GSS - Italian Version, April 2011)


Estimated Enrollment: 3170
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with primary open-angle glaucoma (POAG).

Criteria

Inclusion Criteria:

Patients with instrumental diagnosis of POAG, already being treated at the center or at the time of diagnosis

  • Age > 18 years
  • Ability to understand and answer to the questionnaires provided by the study
  • Written consent to the processing of personal data.

Exclusion criteria:

  • Female patients who are pregnant, breast-feeding or plan to become pregnant, or female patients of childbearing potential not using reliable means of birth control
  • Concurrent abuse of alcohol and drugs
  • Concurrent participation in any other clinical trial that tests drugs / medical devices within the last 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742104

Locations
Italy
Clinica Oculistica - Ospedale S. Salvatore
L'Aquila, AQ, Italy, 67100
U.O.Oftalmologia - Policlinico di Bari
Bari, BA, Italy, 70124
U.O. Oftalmologia Universitaria - Policlinico S. Orsola Malpighi
Bologna, BO, Italy, 40138
Dipartimento di Oftalmologia e Scienze Visive, Centro per lo studio del glaucoma - Spedali Civili
Brescia, BS, Italy, 25123
Reparto di Oculistica-Azienda Ospedaliera di Desenzano del Garda
Desenzano del Garda, BS, Italy, 25015
U.O. Oculistica - Ospedale Civile S. Giovanni di Dio
Cagliari, CA, Italy, 09100
Dipartimento Scienze per la Salute, Sezione Farmacologia Oculare - Università del Molise - Clinica Villa Maria,
Campobasso, CB, Italy, 86100
Clinica Oftalmologica-Ospedale Clinicizzato SS. Annunziata
Chieti, CH, Italy, 66100
U.O. Clinica Oculistica- A.O. Universitaria Policlinico Vittorio Emanuele
Catania, CT, Italy, 95123
U.O. Oculistica - Azienda Ospedaliera Universitaria Mater Domini
Catanzaro, CZ, Italy, 88100
Clinica Oculistica - Azienda Ospedaliera Ospedale San Martino
Genova, GE, Italy, 16132
U.O. Oculistica, Fondazione IRCCSS Ca' Granda Ospedale Maggiore Policlinico - Regina Elena
Milano, MI, Italy, 20122
Dipartimento Testa-Collo, Clinica Oculistica - Ospedale San Paolo
Milano, MI, Italy, 20142
Presidio Unico IRCCS S. Luca/S. Michele - Istituto Auxologico Italiano
Milano, MI, Italy, 20145
Clinica Oculistica - Azienda Ospedaliera Universitaria
Parma, PR, Italy, 43126
Clinica Oculistica - Fondazione IRCCS policlinico San Matteo
Pavia, PV, Italy, 27100
Struttura Complessa di Oculistica - Azienda Ospedaliera Arcispedale S. Maria Nuova
Reggio Emilia, RE, Italy, 42123
U.O.C. di Oculistica - Fondazione Policlinico Tor Vergata
Roma, RM, Italy, 00133
U.O. C. di Oftalmologia - Azienda Ospedaliera Universitaria S. Maria delle Scotte
Siena, SI, Italy, 53100
Clinica Oculistica dell'Università di Torino
Torino, TO, Italy, 10122
Clinica Oculistica - Azienda Ospedaliera Universitaria, Ospedali Riuniti
Trieste, TS, Italy, 34142
Dipartimento di Oculistica-Azienda Ospedaliera Integrata
Verona, VR, Italy, 37126
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
Principal Investigator: Luciano Quaranta, Professor MD Università di Brescia - Italy
  More Information

No publications provided

Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT01742104     History of Changes
Other Study ID Numbers: IRFMN-OG1
Study First Received: December 3, 2012
Last Updated: September 20, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Mario Negri Institute for Pharmacological Research:
glaucoma
primary open-angle glaucoma
observational study
quality of life

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014