ITMO public health
Last update : 01/01/2018 | Version : 2 | ID : 99
| General | |
| Identification | |
| Detailed name | Facteurs de risque du glaucome primitif à angle ouvert chez les sujets atteints d'hypertonie oculaire |
| Sign or acronym | PhotoGRAF |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°906285 |
| General Aspects | |
| Medical area |
Ophthalmology |
| Health determinants |
Addictions Genetic Intoxication Nutrition Occupation Pollution |
| Others (details) | Glaucoma |
| Keywords | risk factors glaucoma |
| Scientific investigator(s) (Contact) | |
| Name of the director | Troy |
| Surname | Sylvie |
| Address | 23-25 avenue du Dr Lannelongue, 75668 Paris cedex 14 |
| Phone | +33 (0)1 58 07 34 10 |
| sylvie.troy@pfizer.com | |
| Unit | Pfizer |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Pfizer |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Pfizer |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Selection and recruitment of subjects having the required inclusion criteria by the participating physicians |
| Database objective | |
| Main objective |
Main: - Evaluate the differences between the cases afflicted with primary open-angle glaucoma (POAG) and the controls afflicted with isolated ocular hypertension (OHT) concerning the potential risk factors, including sociodemographic factors, systemic diseases and treatments in progress, family antecedents of glaucoma, the duration of the disease, the factors linked to the eye, nutritional factors and the exposure to environmental neurotoxic compounds. Secondary: - Derive a predictive function by using the significant risk factors, in such a way as to assist ophthalmologists in classifying patients having a hypertonia with a high risk of developing glaucoma |
| Inclusion criteria |
For the cases: - Male or female aged 40 years or older; - Patients with a diagnosed POAG, confirmed by a structural and function degradation; - Patients for whom a IOP > 21 mm Hg was recorded at one time in the evolution of the disease. For the controls - Male or female paired with the age of the case (± 2 years); - Patients having an IOP > 21 mm Hg on the day of the examination and/or a hypotonisant treatment; - Patients with a visual acuity with optimal correction higher than 5/10; - Patients with no anomaly in the visual field characteristic of glaucoma. |
| Population type | |
| Age |
Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2006 |
| Date of last collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 391 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Care consumption (detail) |
Medical/paramedical consultation |
| Procedures | |
| Data collection method | Collection of data using paper CRF supplemented by the participating physicians. |
| Classifications used | BNF |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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