Genetic and Risk Factors in Exfoliation Glaucoma Patients

Completed

• Conditions: Glaucoma Capsulare; Genetic Predisposition to Disease; Risk Reduction
• Interventions: Other: No intervention

• Registration Number: NCT06237764
• Lead Sponsor: Göteborg University

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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2019-01-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-06
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Genetics in exfoliation glaucoma	No intervention	Prospective recruited patients suffering from exfoliation glaucoma.

Primary Outcome Measures

Name	Time	Method
Visual field progression using the guided progression analysis (GPA) strategy	At least three years follow-up	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.
Visual field progression using visual field index (VFI)	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.
Visual field progression using mean deviation (MD)	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.

Trial Locations

Locations (1)

Skaraborg Hospital; 🇸🇪 Skövde, Sweden