Genetic and Risk Factors in Exfoliation Glaucoma Patients

NCT06237764 | Completed

• 1 other identifier: Glaugene1
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma Capsulare; Genetic Predisposition to Disease; Risk Reduction

Keywords

Glaucoma; Exfoliation; Risk factors; Genetics

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Genetics in exfoliation glaucoma

Prospective recruited patients suffering from exfoliation glaucoma.

Other: No intervention

Interventions

No intervention OTHER

No intervention.

Genetics in exfoliation glaucoma

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Skaraborg Hospital

Skövde, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36564963 RESULT

Biospecimen

Retention: NONE RETAINED

Blood samples.

MeSH Terms

Conditions

Exfoliation Syndrome; Genetic Predisposition to Disease; Risk Reduction Behavior; Glaucoma

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Ocular Hypertension

Study Officials

• Marcelo Ayala, MD/PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: February 1, 2024
• Study Start: January 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: January 1, 2019
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data already available upon request until the end of 2026.
• Access Criteria: Other researchers working with exfoliation glaucoma patients.

Locations

SE (1)