Correlation of Structure and Function in Glaucoma | NCT05954637

Studies
Correlation of Structure and Function in Glaucoma

NCT05954637

Sponsor

Vienna Hospital Association

Status

Completed

Last Update Posted

Dec 2, 2025Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Glaucoma

Interventions

Optical coherence tomography

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Jul 10, 2023

First Submission Date that Met QC Criteria

Jul 10, 2023

First Posted Date

Jul 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Dec 2, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prim. Univ.-Prof. Dr. Pia Veronika Vécsei-Marlovits, MSc, MB, Head of Department of Ophthalmology, Vienna Hospital AssociationPrincipal Investigator

Lead Sponsor

Vienna Hospital AssociationOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical coherence tomography	Device	Heidelberg Engineering Spectralis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Glaucoma Activity Limitation score		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Diagnosis of glaucomatous optic neuropathy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pia V Vécsei-Marlovits, MD, MSc, MBA	Department of Ophthalmology, Clinic Hietzing, Vienna Healthcare Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Clinic Hietzing, Vienna Healthcare Group		Vienna	State of Vienna	1130	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided