Correlation of Structure and Function in Glaucoma

• Sponsor: Vienna Hospital Association (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05954637
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 10.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: Optical coherence tomography

Study Design

• Study Type: Observational
• Anticipated Enrollment: 84 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Correlation of Structure and Function in Glaucoma
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Outcome Measures

Primary Outcome Measures

1. Association of retinal sensitivity with peripapillary retinal nerve fiber layer thickness [1 day]

2. Association of retinal sensitivity with peripapillary vessel density [1 day]

Secondary Outcome Measures

1. Glaucoma Activity Limitation score [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, Clinic Hietzing, Vienna Healthcare Group	Vienna		Austria	1130

Sponsors and Collaborators

• Vienna Hospital Association

Investigators

• Principal Investigator: Pia V Vécsei-Marlovits, MD, MSc, MBA, Department of Ophthalmology, Clinic Hietzing, Vienna Healthcare Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prim. Univ.-Prof. Dr. Pia Veronika Vécsei-Marlovits, MSc, MB, Head of Department of Ophthalmology, Vienna Hospital Association
• ClinicalTrials.gov Identifier: NCT05954637
• Other Study ID Numbers: struct_funct_glaucoma
• First Posted: Jul 20, 2023
• Last Update Posted: Jul 20, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Jul 20, 2023