Clinical trial NCT06237764: Genetic and Risk Factors in Exfoliation Glaucoma Patients
Official title: Genetic and Risk Factors in Exfoliation Glaucoma Patients in Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma Capsulare
Genetic Predisposition to Disease
Risk Reduction
Keywords: Glaucoma
Exfoliation
Risk factors
Genetics
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: Prospective non-randomised cohort study enrolling patients with exfoliation glaucoma. All patients were ophthalmological examined at inclusion. Blood samples were taken for genetic analysis.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual field progression using mean deviation (MD)
timeFrame: At least three years follow-up
measure: Visual field progression using visual field index (VFI)
timeFrame: At least three years follow-up
measure: Visual field progression using the guided progression analysis (GPA) strategy
timeFrame: At least three years follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: Skaraborg Hospital
Study officials:
affiliation: Göteborg University
name: Marcelo Ayala, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.