Multicentric Observational Study on Quality of Life in Glaucoma
Multicentric Observational Clinical Study on Quality of Life in Patients With Glaucoma in Italy
1 other identifier
observational
3,226
1 country
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 3, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 20, 2015
April 1, 2015
2.9 years
December 3, 2012
April 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life questionnaires
National Eye Institute Visual Function Questionnaire (NEI-VFQ-25 - Italian Version, Jan 2003) Glaucoma Symptom Scale (GSS - Italian Version, April 2011)
up to 12 months
Eligibility Criteria
Patients with primary open-angle glaucoma (POAG).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Clinica Oculistica - Ospedale S. Salvatore
L’Aquila, AQ, 67100, Italy
U.O.Oftalmologia - Policlinico di Bari
Bari, BA, 70124, Italy
U.O. Oftalmologia Universitaria - Policlinico S. Orsola Malpighi
Bologna, BO, 40138, Italy
Dipartimento di Oftalmologia e Scienze Visive, Centro per lo studio del glaucoma - Spedali Civili
Brescia, BS, 25123, Italy
Reparto di Oculistica-Azienda Ospedaliera di Desenzano del Garda
Desenzano del Garda, BS, 25015, Italy
U.O. Oculistica - Ospedale Civile S. Giovanni di Dio
Cagliari, CA, 09100, Italy
Dipartimento Scienze per la Salute, Sezione Farmacologia Oculare - Università del Molise - Clinica Villa Maria,
Campobasso, CB, 86100, Italy
Clinica Oftalmologica-Ospedale Clinicizzato SS. Annunziata
Chieti, CH, 66100, Italy
U.O. Clinica Oculistica- A.O. Universitaria Policlinico Vittorio Emanuele
Catania, CT, 95123, Italy
U.O. Oculistica - Azienda Ospedaliera Universitaria Mater Domini
Catanzaro, CZ, 88100, Italy
Clinica Oculistica - Azienda Ospedaliera Ospedale San Martino
Genova, GE, 16132, Italy
U.O. Oculistica, Fondazione IRCCSS Ca' Granda Ospedale Maggiore Policlinico - Regina Elena
Milan, MI, 20122, Italy
Dipartimento Testa-Collo, Clinica Oculistica - Ospedale San Paolo
Milan, MI, 20142, Italy
Presidio Unico IRCCS S. Luca/S. Michele - Istituto Auxologico Italiano
Milan, MI, 20145, Italy
Clinica Oculistica - Azienda Ospedaliera Universitaria
Parma, PR, 43126, Italy
Clinica Oculistica - Fondazione IRCCS policlinico San Matteo
Pavia, PV, 27100, Italy
Struttura Complessa di Oculistica - Azienda Ospedaliera Arcispedale S. Maria Nuova
Reggio Emilia, RE, 42123, Italy
U.O.C. di Oculistica - Fondazione Policlinico Tor Vergata
Roma, RM, 00133, Italy
U.O. C. di Oftalmologia - Azienda Ospedaliera Universitaria S. Maria delle Scotte
Siena, SI, 53100, Italy
Clinica Oculistica dell'Università di Torino
Torino, TO, 10122, Italy
Clinica Oculistica - Azienda Ospedaliera Universitaria, Ospedali Riuniti
Trieste, TS, 34142, Italy
Related Publications (1)
Riva I, Legramandi L, Katsanos A, Oddone F, Rulli E, Roberti G, Quaranta L; Italian Study Group on QoL in Glaucoma. Influence of Sociodemographic Factors on Disease Characteristics and Vision-related Quality of Life in Primary Open-angle Glaucoma Patients: The Italian Primary Open Angle Glaucoma Study (IPOAGS). J Glaucoma. 2018 Sep;27(9):776-784. doi: 10.1097/IJG.0000000000000989.
PMID: 29781833DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luciano Quaranta, Professor MD
Università di Brescia - Italy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2012
First Posted
December 5, 2012
Study Start
March 1, 2012
Primary Completion
February 1, 2015
Study Completion
April 1, 2015
Last Updated
April 20, 2015
Record last verified: 2015-04