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RecruitingNCT03423758Updated May 23, 2025

Investigating the Genetic Basis of Pseudoexfoliation Syndrome, Angle-closure Glaucoma and Primary Open-angle Glaucoma

An observational study in Glaucoma, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Medical University of Vienna · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
21 Years to 105 Years
Sex
All
01

Study summary

There is increasing evidence that there are genetic risk factors for several forms of glaucoma, such as glaucoma caused by pseudoexfoliation syndrome (PXF) ,primary angle closure glaucoma (PACG) and primary open-angle glaucoma (POAG). The aim of the present prospective, multi-center, case-control study is to identify susceptibility genes/loci for PXF, PACG and POAG using a whole genome association (WGA) approach.

Read the detailed description

As worldwide populations become older because of shifts in demography, PXF may become a matter of greater concern. The search for genes responsible for PXF may lead to the identification of key molecules in pathways critical to the normal functioning of the eye. A better understanding of normal eye function may in turn lead to more accurate diagnosis and prognosis of ocular development, and inevitably to the emergence of novel classifications based on knowledge of the molecular pathology. Such knowledge may lead to more rational disease classification, better diagnostic tests, and improved prognostic accuracy. This is of particular relevance to PXF since there is a shortage of early reliable diagnostic tests and much evidence that the early commencement of treatment can arrest progressive asymptomatic loss of vision due to PXF-related glaucoma.

The search for genes responsible for PACG may lead to the identification of key molecules in pathways critical to the normal development of the eye. A better understanding of eye development may in turn lead to more accurate diagnosis and prognosis of ocular development, and inevitably to the emergence of novel classifications based on knowledge of the molecular pathology. Such knowledge may lead to more rational disease classification, better diagnostic tests, and improved prognostic accuracy. This is of particular relevance to glaucoma since there is a shortage of early reliable diagnostic tests and much evidence that the early commencement of treatment can arrest progressive asymptomatic loss of vision for which the disease is renowned.

Identification of responsible genes for POAG development can on one hand broaden our knowledge on disease pathophysiology and on the other hand open new doors in the search for pharmacological disease modification. Especially the latter is urgently needed as IOP has for many years been the only pharmacological target and fails to prevent disease progression in a certain proportion of POAG patients.

02

Conditions studied

  • Glaucoma

Keywords

  • Pseudoexfoliation Glaucoma, Angle block glaucoma, Primary Open-Angle Glaucoma, Genetic
03

Who can participate

Ages eligible
21 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

  1. Normal Healthy group
  2. Patients with Pseudoexfoliation Glaucoma
  3. Patients with Angle closure Glaucoma
  4. Patients with Primary open-angle Glaucoma

Inclusion criteria

  1. For patients with PXF:

    • Patients with confirmed pseudoexfoliation syndrome (exfoliation glaucoma / pseudoexfoliation of the lens) in the medical history
    • Informed consent
    • Age 50 years or more
  2. For patients with PACG:

    • Patients with confirmed acute primary angle closure (PAC) or primary angle closure glaucoma (PACG) in the medical history
    • Informed consent
    • Age 21 years or more
  3. For healthy controls:

    • No evidence of PXF, glaucoma or uveitis during clinical examination or in the medical history
    • No evidence of major ocular disease such as diabetic retinopathy, age related macular degeneration or conditions with genetic background during clinical examination or in the medical history
    • Age more than 60 years
    • Informed consent
  4. For patients with POAG:

    • Patients with confirmed primary open angle glaucoma (POAG)
    • No evidence of exfoliation glaucoma / pseudoexfoliation of the lens or pigment glaucoma
    • Informed consent
    • Age 30 or more

Exclusion criteria

Exclusion Criteria:

  • Patients and subjects will be excluded if one or more of the following criteria apply:
  • Neovascular glaucoma
  • Active or history of uveitis
  • Secondary angle closure such as neovascular glaucoma or uveitis/inflammatory eye disease
  • Inability to give informed consent
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy controls

    Healthy subjects with age more than 60 years

    Other: Blood sample

  • Pseudoexfoliation Glaucoma

    Already diagnosed Pseudoexfoliation glaucoma patients with age more than 50 years

    Other: Blood sample

  • Angle closure Glaucoma

    Already diagnosed Angle closure Glaucoma patients with age more than 21 years

    Other: Blood sample

  • Primary open-angle Glaucoma

    Already diagnosed primary open-angle glaucoma with age more than 30 years

    Other: Blood sample

Interventions

  • OtherBlood sample

    Blood sample

05

What researchers measure

Primary outcomes

  1. Genetic markers

    To identify the genetic markers in a whole genome association screen which show very strong association with PXF, ACG and POAG. The genomic regions identified from the above analyses will be analyzed using high density single nucleotide polymorphism (SNP) chips and/or sequencing of positional candidate genes to identify causal variants.

    Time frame: 1 day

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03423758
Lead sponsor
Medical University of Vienna
Responsible party
Gerhard Garhofer (Assoc. Prof. PD Dr., Medical University of Vienna) — Principal investigator
First posted
Feb 6, 2018
Start date
May 30, 2017
Primary completion
Jan 30, 2026 (estimated)
Completion
Jan 30, 2026 (estimated)
Last update
May 23, 2025

Study contacts

Gerhard Garhöfer
Contact
gerhard.garhoefer@meduniwien.ac.at
0140 400 29880
Doreen Schmidl
Contact
doreen.schmidl@meduniwien.ac.at
0140 400 29880
Gerhard Garhöfer
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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