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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014