Multicentric Observational Study on Quality of Life in Glaucoma - Full Text View

Purpose

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

Glaucoma Symptom Scale (GSS) and
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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

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:	3000
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

Contacts

Contact: Irene Floriani, Ph.D.

+ 3902 3901 4695

irene.floriani@marionegri.it

Locations

Italy
Clinica Oculistica - Ospedale S. Salvatore	Not yet recruiting
L'Aquila, AQ, Italy, 67100
Contact: Prof. Marco Ciancaglini, MD
Principal Investigator: Prof. Marco Ciancaglini, MD
U.O.Oftalmologia - Policlinico di Bari	Recruiting
Bari, BA, Italy, 70124
Contact: Prof. Carlo Sborgia, MD
Contact: Dr. Francesco Cantatore, MD
Principal Investigator: Prof. Carlo Sborgia, MD
U.O. Oftalmologia Universitaria - Policlinico S. Orsola Malpighi	Not yet recruiting
Bologna, BO, Italy, 40138
Contact: Prof. Emilio Campos, MD
Contact: Dr. Mauro Cellini, MD
Principal Investigator: Prof. Emilio Campos, MD
Sub-Investigator: Dr. Mauro Cellini, MD
Dipartimento di Oftalmologia e Scienze Visive, Centro per lo studio del glaucoma - Spedali Civili	Recruiting
Brescia, BS, Italy, 25123
Contact: Prof. Luciano Quaranta, MD
Principal Investigator: Prof. Luciano Quaranta, MD
Reparto di Oculistica-Azienda Ospedaliera di Desenzano del Garda	Recruiting
Desenzano del Garda, BS, Italy, 25015
Contact: Dr. Vincenzo Pucci, MD
Contact: Dr. Marta Cassamali, MD
Principal Investigator: Dr. Vincenzo Pucci, MD
Sub-Investigator: Dr. Marta Cassamali, MD
U.O. Oculistica - Ospedale Civile S. Giovanni di Dio	Recruiting
Cagliari, CA, Italy, 09100
Contact: Prof. Maurizio Fossarello, MD
Contact: Dr. Alberto Cuccu, MD
Principal Investigator: Prof. Maurizio Fossarello, MD
Sub-Investigator: Dr. Alberto Cuccu, MD
Dipartimento Scienze per la Salute, Sezione Farmacologia Oculare - Università del Molise - Clinica Villa Maria,	Recruiting
Campobasso, CB, Italy, 86100
Contact: Prof. Ciro Costagliola, MD
Principal Investigator: Prof. Ciro Costagliola, MD
Clinica Oftalmologica-Ospedale Clinicizzato SS. Annunziata	Not yet recruiting
Chieti, CH, Italy, 66100
Contact: Prof. Leonardo Mastropasqua, MD
Principal Investigator: Prof. Leonardo Mastropasqua, MD
U.O. Clinica Oculistica- A.O. Universitaria Policlinico Vittorio Emanuele	Recruiting
Catania, CT, Italy, 95123
Contact: Prof. Maurizio Uva, MD
Contact: Dr. Antonio Longo, MD
Principal Investigator: Prof. Maurizio Uva, MD
Sub-Investigator: Dr. Antonio Longo, MD
U.O. Oculistica - Azienda Ospedaliera Universitaria Mater Domini	Recruiting
Catanzaro, CZ, Italy, 88100
Contact: Dr. Luigi Varano, MD
Principal Investigator: Dr. Luigi Varano, MD
Clinica Oculistica - Azienda Ospedaliera Ospedale San Martino	Recruiting
Genova, GE, Italy, 16132
Contact: Prof. Carlo Enrico Traverso, MD
Contact: Dr. Laura Landi, MD
Principal Investigator: Prof. Carlo Enrico Traverso, MD
U.O. Oculistica, Fondazione IRCCSS Ca' Granda Ospedale Maggiore Policlinico - Regina Elena	Recruiting
Milano, MI, Italy, 20122
Contact: Prof. Roberto Ratiglia, MD
Contact: Dr. Aldo Rossi, MD
Principal Investigator: Prof. Roberto Ratiglia, MD
Sub-Investigator: Dr. Aldo Rossi, MD
Dipartimento Testa-Collo, Clinica Oculistica - Ospedale San Paolo	Recruiting
Milano, MI, Italy, 20142
Contact: Prof. Luca Rossetti, MD
Contact: Dr. Emanuele Maggiolo, MD
Principal Investigator: Prof. Luca Rossetti, MD
Sub-Investigator: Dr. Emanuele Maggiolo, MD
Presidio Unico IRCCS S. Luca/S. Michele - Istituto Auxologico Italiano	Recruiting
Milano, MI, Italy, 20145
Contact: Dr. Luciana Carmassi, MD
Principal Investigator: Dr. Luciana Carmassi, MD
Clinica Oculistica - Azienda Ospedaliera Universitaria	Recruiting
Parma, PR, Italy, 43126
Contact: Prof. Stefano Gandolfi, MD
Principal Investigator: Prf. Stefano Gandolfi, MD
Clinica Oculistica - Fondazione IRCCS policlinico San Matteo	Recruiting
Pavia, PV, Italy, 27100
Contact: Dr. Gemma CM Rossi, MD
Principal Investigator: Dr. Gemma CM Rossi, MD
Struttura Complessa di Oculistica - Azienda Ospedaliera Arcispedale S. Maria Nuova	Recruiting
Reggio Emilia, RE, Italy, 42123
Contact: Dr. Luigi Fontana, MD
Contact: Dr. Sylvia Marchi, MD
Principal Investigator: Dr. Luigi Fontana, MD
Sub-Investigator: Dr. Sylvia Marchi, MD
U.O.C. di Oculistica - Fondazione Policlinico Tor Vergata	Not yet recruiting
Roma, RM, Italy, 00133
Contact: Prof. Gianluca Manni, MD
Principal Investigator: Prof. Gianluca Manni, MD
U.O. C. di Oftalmologia - Azienda Ospedaliera Universitaria S. Maria delle Scotte	Recruiting
Siena, SI, Italy, 53100
Contact: Dr. Paolo Frezzotti, MD
Principal Investigator: Dr. Paolo Frezzotti, MD
Clinica Oculistica dell'Università di Torino	Recruiting
Torino, TO, Italy, 10122
Contact: Prof. Teresa Rolle, MD
Principal Investigator: Prof. Teresa Rolle, MD
Clinica Oculistica - Azienda Ospedaliera Universitaria, Ospedali Riuniti	Recruiting
Trieste, TS, Italy, 34142
Contact: Prof. Daniele Tognetto, MD
Contact: Dr. Odilla Vattovani, MD
Principal Investigator: Prof. Daniele Tognetto, MD
Sub-Investigator: Dr. Odilla Vattovani, MD
Dipartimento di Oculistica-Azienda Ospedaliera Integrata	Not yet recruiting
Verona, VR, Italy, 37126
Contact: Prof. Giorgio Marchini, MD
Principal Investigator: Prof. Giorgio Marchini, MD

Sponsors and Collaborators

Mario Negri Institute for Pharmacological Research

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:	December 4, 2012
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 June 17, 2013