Primary Open-angle GlaucomaNCT01742104
Multicentric Observational Study on Quality of Life in Glaucoma
An observational study of Primary Open-angle Glaucoma, run by Mario Negri Institute for Pharmacological Research at 21 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma
- How many people
- 3,226 participants
- Where
- 21 sitesItaly
- Study dates
- Mar 2012to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary open-angle glaucoma (POAG).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Italy21 sites
U.O.Oftalmologia - Policlinico di Bari
Bari, BA, 70124
U.O. Oftalmologia Universitaria - Policlinico S. Orsola Malpighi
Bologna, BO, 40138
Dipartimento di Oftalmologia e Scienze Visive, Centro per lo studio del glaucoma - Spedali Civili
Brescia, BS, 25123
U.O. Oculistica - Ospedale Civile S. Giovanni di Dio
Cagliari, CA, 09100
Dipartimento Scienze per la Salute, Sezione Farmacologia Oculare - Università del Molise - Clinica Villa Maria,
Campobasso, CB, 86100
U.O. Clinica Oculistica- A.O. Universitaria Policlinico Vittorio Emanuele
Catania, CT, 95123
U.O. Oculistica - Azienda Ospedaliera Universitaria Mater Domini
Catanzaro, CZ, 88100
Clinica Oftalmologica-Ospedale Clinicizzato SS. Annunziata
Chieti, CH, 66100
Reparto di Oculistica-Azienda Ospedaliera di Desenzano del Garda
Desenzano del Garda, BS, 25015
Clinica Oculistica - Azienda Ospedaliera Ospedale San Martino
Genova, GE, 16132
Clinica Oculistica - Ospedale S. Salvatore
L’Aquila, AQ, 67100
U.O. Oculistica, Fondazione IRCCSS Ca' Granda Ospedale Maggiore Policlinico - Regina Elena
Milan, MI, 20122
Dipartimento Testa-Collo, Clinica Oculistica - Ospedale San Paolo
Milan, MI, 20142
Presidio Unico IRCCS S. Luca/S. Michele - Istituto Auxologico Italiano
Milan, MI, 20145
Clinica Oculistica - Azienda Ospedaliera Universitaria
Parma, PR, 43126
Clinica Oculistica - Fondazione IRCCS policlinico San Matteo
Pavia, PV, 27100
Struttura Complessa di Oculistica - Azienda Ospedaliera Arcispedale S. Maria Nuova
Reggio Emilia, RE, 42123
U.O.C. di Oculistica - Fondazione Policlinico Tor Vergata
Roma, RM, 00133
U.O. C. di Oftalmologia - Azienda Ospedaliera Universitaria S. Maria delle Scotte
Siena, SI, 53100
Clinica Oculistica dell'Università di Torino
Torino, TO, 10122
Clinica Oculistica - Azienda Ospedaliera Universitaria, Ospedali Riuniti
Trieste, TS, 34142
About this study
Official title: Multicentric Observational Clinical Study on Quality of Life in Patients With Glaucoma in Italy
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).
Read the 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.
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- glaucoma, primary open-angle glaucoma, observational study, quality of life
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 3,226 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciano Quaranta, Professor MD, Principal investigator, Università di Brescia - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742104
- Sponsor's protocol ID
- IRFMN-OG1
- Status last verified
- Apr 2015
- First submitted
- 3 Dec 2012
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29781833
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Observational Clinical Study on Quality of Life in Patients With Glaucoma in Italy
- ClinicalTrials.gov ID
- NCT01742104
- Acronym / sponsor ID
- IRFMN-OG1
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- glaucoma, primary open-angle glaucoma, observational study, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,226 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary open-angle glaucoma (POAG).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
- Derived from this study: PubMed 29781833Riva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano Quaranta, Professor MD principal investigator
Università di Brescia - Italy
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open-angle Glaucoma, run by Mario Negri Institute for Pharmacological Research at 21 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaires (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01742104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.