Clinical trial NCT01742104: Multicentric Observational Study on Quality of Life in Glaucoma
Official title: Multicentric Observational Clinical Study on Quality of Life in Patients With Glaucoma in Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open-angle Glaucoma
Keywords: glaucoma
primary open-angle glaucoma
observational study
quality of life
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 3226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary open-angle glaucoma (POAG).

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).

Detailed description: The study provides two levels of investigation, the first one (transversal phase), for all patients enrolled in the participating centers and the second one (longitudinal phase) conducted in a single cohort of patients with new diagnosis of POAG at enrollment.

The study will take part in around 20 centers specialized in glaucoma treatment and care, distributed throughout the Italian country area. The study aims to recruit a total of 3000 patients, around 200 of which with early diagnosis: they will represent the longitudinal cohort.

The frequency of visits and the type of examinations will follow the normal clinical practice.

The transversal phase consists of a single visit in which all socio-demographic and clinical characteristics of patients will be collected; during this visit patients will receive the NEI-VFQ 25 and the GSS questionnaires for measuring QoL (they have be filled in by the patient himself). For newly diagnosed patients, data collected during this visit will be consider as baseline, then they will enter in the longitudinal phase and will underwent two subsequent visits, the first one after about 6 months from baseline and the second one after a further 6 months (12 months from baseline). During the two subsequent visits the same data as the baseline will be collected, excluding for the socio-demographic data.

Patients will underwent examinations and therapy suitable for their disease treatment, based on physician judgment and according to the normal clinical practice.

All patient data will be collected on Case Report Form(CRF). All data contained in the CRF and in the QoL questionnaires, will be entered into an electronic database and will be checked in order to assess the plausibility, internal consistencies, errors or missing values. For each missing/loose/illegible/wrong data a request for clarification will be automatically generated by the system; it will be named "Query Form" and will be sent to the investigator for answers. At the end of the validation process, the database will be "frozen" and it will be used for statistical analysis.

The data were collected in an absolutely anonymous way. No data can be traced back up to the patient personal information or history.

All patients enrolled in the study, except for those with inclusion/exclusion criteria violations, will be considered in the statistical analysis.

The general characteristics of the study sample will be described. Qualitative variables will be described by means of the absolute and relative frequencies calculation, those quantitative with mean, standard deviation, quartiles, minimum, maximum, number of observations.

With regard to the QoL scale, the total score and subscale will be calculated. The same approach will be used within subgroups defined on the basis of socio-demographic and clinical characteristics.

As per the calculation of the sample size, it is estimated that at present in Italy there are 500,000 patients affected by glaucoma and about 50 centers specialized in the disease treatment.

A sample of 3000 patients with POAG and the involvement of at least 20 centers specialized in the glaucoma treatment are considered to be a representative estimation of reality in the Italian coutry area.

With a sample size of at least 3000 patients it is possible to calculate the 95%confidence interval of the estimated value of any parameter collected with an inaccuracy who not exceed 3.6%.

It is assumed that it will be possible to isolate about 200 patients in first diagnosis, in which the time course of the QOL scales scores will be described for the entire cohort and into predetermined patient subgroups.

For a successful implementation of the procedures required by the study the following activities are provided:

* Start-up and follow-up meetings, with the aim of sharing operating procedures, training the investigators to use the study tools for the collection of data and following-up study issues;
* Project dedicated Help Desk.

This study will be conducted according to AIFA March 20, 2008, "Guidelines for the classification and management of observational studies on drugs" and the principles expressed in the guidelines for the 'Good Epidemiology Practice' (GEP) in force in Europe.

A patient's informed consent and a consent to the processing of their data, signed by each patient, will be obtained before the study entry.

Eligibility 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.

Primary outcomes:
measure: Quality of life questionnaires
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Clinica Oculistica - Ospedale S. Salvatore
state: AQ
city: Bari
country: Italy
facility: U.O.Oftalmologia - Policlinico di Bari
state: BA
city: Bologna
country: Italy
facility: U.O. Oftalmologia Universitaria - Policlinico S. Orsola Malpighi
state: BO
city: Brescia
country: Italy
facility: Dipartimento di Oftalmologia e Scienze Visive, Centro per lo studio del glaucoma - Spedali Civili
state: BS
city: Desenzano del Garda
country: Italy
facility: Reparto di Oculistica-Azienda Ospedaliera di Desenzano del Garda
state: BS
city: Cagliari
country: Italy
facility: U.O. Oculistica - Ospedale Civile S. Giovanni di Dio
state: CA
city: Campobasso
country: Italy
facility: Dipartimento Scienze per la Salute, Sezione Farmacologia Oculare - Università del Molise - Clinica Villa Maria,
state: CB
city: Chieti
country: Italy
facility: Clinica Oftalmologica-Ospedale Clinicizzato SS. Annunziata
state: CH
city: Catania
country: Italy
facility: U.O. Clinica Oculistica- A.O. Universitaria Policlinico Vittorio Emanuele
state: CT
city: Catanzaro
country: Italy
facility: U.O. Oculistica - Azienda Ospedaliera Universitaria Mater Domini
state: CZ
city: Genova
country: Italy
facility: Clinica Oculistica - Azienda Ospedaliera Ospedale San Martino
state: GE
city: Milano
country: Italy
facility: U.O. Oculistica, Fondazione IRCCSS Ca' Granda Ospedale Maggiore Policlinico - Regina Elena
state: MI
city: Milano
country: Italy
facility: Dipartimento Testa-Collo, Clinica Oculistica - Ospedale San Paolo
state: MI
city: Milano
country: Italy
facility: Presidio Unico IRCCS S. Luca/S. Michele - Istituto Auxologico Italiano
state: MI
city: Parma
country: Italy
facility: Clinica Oculistica - Azienda Ospedaliera Universitaria
state: PR
city: Pavia
country: Italy
facility: Clinica Oculistica - Fondazione IRCCS policlinico San Matteo
state: PV
city: Reggio Emilia
country: Italy
facility: Struttura Complessa di Oculistica - Azienda Ospedaliera Arcispedale S. Maria Nuova
state: RE
city: Roma
country: Italy
facility: U.O.C. di Oculistica - Fondazione Policlinico Tor Vergata
state: RM
city: Siena
country: Italy
facility: U.O. C. di Oftalmologia - Azienda Ospedaliera Universitaria S. Maria delle Scotte
state: SI
city: Torino
country: Italy
facility: Clinica Oculistica dell'Università di Torino
state: TO
city: Trieste
country: Italy
facility: Clinica Oculistica - Azienda Ospedaliera Universitaria, Ospedali Riuniti
state: TS
Study officials:
affiliation: Università di Brescia - Italy
name: Luciano Quaranta, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.