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Multicentric Observational Study on Quality of Life in Glaucoma

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ClinicalTrials.gov Identifier: NCT01742104
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : April 20, 2015
Sponsor:
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

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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).
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.

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 ClinicalTrials.gov identifier (NCT number): NCT01742104


Locations
Show Show 21 study locations
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
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Principal Investigator: Luciano Quaranta, Professor MD Università di Brescia - Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT01742104    
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:
glaucoma
primary open-angle glaucoma
observational study
quality of life
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases