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Prospective Constitution of Database Gathering Data of Patients Suffering From Glaucoma Followed at University Hospital of Grenoble (BDD_GLAUCOME)

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ClinicalTrials.gov Identifier: NCT02867527
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
Few publications provide information on the natural history of glaucoma, outside of clinical trials do not always reflect what is observed in common situation for various reasons (specific selection criteria and sometimes restrictive, stronger motivations patients and physicians to comply with follow-up visits and prescribed treatments, etc.). Therefore, much information on the natural history of glaucoma are unknown to date (degradation rate of visual field and visual function over time, risk of blindness in the years following diagnosis, effects of various treatments to reduce intraocular pressure and preserving visual field deterioration, etc.). Obtaining such important data to improve the management of glaucoma patients (choice of treatment methods, identification of predictors of rapid change that can make choosing more aggressive treatment and more regular monitoring, etc.) requires the establishment of cohort of patients followed and treated with the methods usually used in current practice, and besides therapeutic trial.

Condition or disease
Glaucoma

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: Prospective Constitution of Database Gathering Data of Patients Suffering From Glaucoma Followed at University Hospital of Grenoble
Study Start Date : January 2014
Estimated Primary Completion Date : January 2029
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Degradation rate of visual field and visual function in patients treated with the methods usually used in current practice [ Time Frame: 15 years ]


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
The data from all major subjects with primary or secondary glaucoma and examined for initial management or monitoring in the ophthalmology department of the University Hospital of Grenoble will be included in the database.
Criteria

Inclusion Criteria:

  • Patients whose age is above 18 years
  • Patients with primary or secondary glaucoma or both sides

Exclusion Criteria:

  • Major person under guardianship or unable to consent
  • Patient Refusal

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): NCT02867527


Contacts
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Contact: Florent APTEL 00 334 76 76 55 48 faptel@chu-grenoble.fr

Locations
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France
University Hospital Grenoble Recruiting
Grenoble, France
Contact: Florent Aptel    00 334 76 76 55 48    faptel@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble

Additional Information:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02867527     History of Changes
Other Study ID Numbers: 38RC13.414
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases