Multicentric Observational Study on Quality of Life in Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742104
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : April 20, 2015
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Brief Summary:

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 or disease
Primary Open-angle Glaucoma

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 3226 participants
Observational Model: Cohort
Official Title: Multicentric Observational Clinical Study on Quality of Life in Patients With Glaucoma in Italy
Study Start Date : March 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Primary Outcome Measures :
  1. Quality of life questionnaires [ Time Frame: up to 12 months ]
    National Eye Institute Visual Function Questionnaire (NEI-VFQ-25 - Italian Version, Jan 2003) Glaucoma Symptom Scale (GSS - Italian Version, April 2011)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary open-angle glaucoma (POAG).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01742104

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
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Principal Investigator: Luciano Quaranta, Professor MD Università di Brescia - Italy

Responsible Party: Mario Negri Institute for Pharmacological Research Identifier: NCT01742104     History of Changes
Other Study ID Numbers: IRFMN-OG1
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: April 20, 2015
Last Verified: April 2015

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

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