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Prospective non-randomised cohort study enrolling patients with exfoliation glaucoma. All patients were ophthalmological examined at inclusion. Blood samples were taken for genetic analysis.
Patients & examinations In this prospective non-randomised cohort study, the investigators enrolled patients with exfoliation glaucoma at the Ophthalmology Department of the Skaraborg's Hospital, Skövde, and Sahlgrenska University Hospital, Gothenburg, from 1st January, 2014, to 31st December, 2017. All patients were followed-up for three years ± three months. Informed consent was obtained from all patients. The study protocol was granted ethical approval by the University of Gothenburg (DN:119-12). The study was performed in accordance with the tenets of the Declaration of Helsinki.
At the recruiting visit, an ophthalmic nurse checked the visual acuity of patients with a Snellen's chart and performed a visual field test. Humphrey Field Analysis was performed using the software threshold 24-2. Subsequently, an ophthalmologist measured the intracoular pressure (IOP) with a Goldmann applanation tonometer and performed slit-lamp biomicroscopy, including gonioscopy. Pupils were then dilated with 2.5% phenylephrine and 0.5% tropicamide. After 20 min, the presence of exfoliation was confirmed, and the optic nerve was assessed using a 90-D lens. Subsequently, the central corneal thickness (CCT) was measured using an ultrasound device. The average value of seven measurements was automatically calculated. At the end of the visit, blood samples were collected. The number of medicines was registered as the number of compounds and not the number of bottles used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genetics in exfoliation glaucoma | Prospective recruited patients suffering from exfoliation glaucoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual field progression using mean deviation (MD) | The visual field progression was studied with three methods. The first method was based on MD visual field. The difference in MD values from the beginning to the end of the study was calculated. Higher values indicated higher progression. Results will be analyzed using linear regression. | At least three years follow-up |
| Visual field progression using visual field index (VFI) | The second method was based on VFI. A device calculated the VFI and performed a regression analysis to calculate the rate of progression (ROP). The machine calculated the ROP as the amount of VFI deterioration (%)/year. The ROP calculation is also referred to as a 'trend analysis.' Results will be analyzed using linear regression. | At least three years follow-up |
| Visual field progression using the guided progression analysis (GPA) strategy | The third method was the GPA, which is also included in the device and performed automatically (GPA Alert) but differs from ROP. GPA is an 'event analysis,' while ROP is a 'trend analysis'. The machine compares every single point before examinations. The GPA alert result options for progression are 'no', 'possible', and 'likely'. We evaluated glaucoma as 'no progression' or 'progression', the latter including both 'possible' and 'likely'. Results will be analyzed using logistic regression. | At least three years follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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In this prospective non-randomised cohort study, the investigators enrolled patients with exfoliation glaucoma at the Ophthalmology Department of the Skaraborg's Hospital, Skövde, and Sahlgrenska University Hospital, Gothenburg.
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo Ayala, MD/PhD | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skaraborg Hospital | Skövde | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36564963 | Result | Ayala M, Zetterberg M, Zettergren A. Single nucleotide polymorphisms in LOXL1 as biomarkers for progression of exfoliation glaucoma in Sweden. Acta Ophthalmol. 2023 Aug;101(5):521-529. doi: 10.1111/aos.15630. Epub 2022 Dec 23. |
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Ground information of the cohort like age, sex, genetic analysis, risk factors, etc.
Data already available upon request until the end of 2026.
Other researchers working with exfoliation glaucoma patients.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2012 | Jan 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2012 | Jan 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017889 | Exfoliation Syndrome |
| D020022 | Genetic Predisposition to Disease |
| D040242 | Risk Reduction Behavior |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D004198 | Disease Susceptibility |
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Blood samples.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D009798 | Ocular Hypertension |