NCT05954637

Brief Summary

The aim of the study is to correlate structure and function in patients with glaucoma. To this end, a cross-sectional study unsing perimetry and optical coherence tomography is performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

July 10, 2023

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Association of retinal sensitivity with peripapillary retinal nerve fiber layer thickness

    1 day

  • Association of retinal sensitivity with peripapillary vessel density

    1 day

Secondary Outcomes (1)

  • Glaucoma Activity Limitation score

    1 day

Interventions

Heidelberg Engineering Spectralis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the Department of Ophthalmology, Clinic Hietzing, Vienna Healthcare Group, who have been diagnosed with "glaucomatous optic neuropathy" are eligible for inclusion in the study.

You may qualify if:

  • \- Diagnosis of glaucomatous optic neuropathy

You may not qualify if:

  • Age \< 18 years
  • Diabetes
  • Pregnancy
  • Hypertensive retinopathy
  • Smoking
  • Intraocular surgery 1 month prior to study entry
  • Systemic or ocular disease, excluding glaucoma, which the investigator believes could affect the test results
  • Insufficient quality of the optical coherence tomography imaging
  • Insufficient cooperation during examinations or measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Clinic Hietzing, Vienna Healthcare Group

Vienna, Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Pia V Vécsei-Marlovits, MD, MSc, MBA

    Department of Ophthalmology, Clinic Hietzing, Vienna Healthcare Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Ophthalmology

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 20, 2023

Study Start

July 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations