- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06237764
Genetic and Risk Factors in Exfoliation Glaucoma Patients
Genetic and Risk Factors in Exfoliation Glaucoma Patients in Sweden
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Skövde, Sweden
- Skaraborg Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- A diagnosis of exfoliation glaucoma based on the criteria established by the European Glaucoma Society Terminology and Guidelines for Glaucoma, i.e., an untreated IOP of ≥21 mmHg, an open anterior chamber angle, glaucomatous visual field defects (at least two repeatable Humphrey 24-2 tests), glaucomatous optic nerve damage, and the presence of exfoliation material.
- Patients must performed at least five reliable visual field tests during the 3-year follow-up, with reliability defined as false positives ≤15%, false negatives ≤20%, and/or fixation losses ≤30%.
- Age ≤85 years at the recruiting visit.
Exclusion Criteria:
- A diagnosis of advanced glaucoma defined as mean deviation (MD) ≥18 decibel (dB) and/or visual field index (VFI) ≤40% because of 'floor effects,' in which further loss of visual field defects can no longer be detected.
- History of glaucoma surgery other than uneventful cataract surgery or selective laser trabeculoplasty (SLT).
- Other eye diseases (central venous occlusion, retinal detachment, etc.) that could affect the visual fields during the 3-year follow-up.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Genetics in exfoliation glaucoma
Prospective recruited patients suffering from exfoliation glaucoma.
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No intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual field progression using mean deviation (MD)
Time Frame: At least three years follow-up
|
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)
Time Frame: At least three years follow-up
|
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.
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At least three years follow-up
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Visual field progression using the guided progression analysis (GPA) strategy
Time Frame: At least three years follow-up
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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.
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At least three years follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcelo Ayala, MD/PhD, Göteborg University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Glaugene1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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