Evaluation of a Novel Method for Increasing Intraocular Pressure in Healthy Subjects

NCT04044274 | Completed

• 1 other identifier: OPHT-120219
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate perfusion is necessary for maintaining tissue function. This applies also for the eye, in which ocular perfusion pressure (OPP) is generally estimated as the difference between mean arterial pressure (MAP) and intraocular pressure (IOP). In the latter formula, IOP substitutes for central retinal venous pressure (CRVP), which is assumed to be slightly higher than IOP to allow blood flow to exit the eye. It has, however, been found that in some patients CRVP is elevated and significantly higher than IOP, which would lead to a decrease in OPP which is not taken in account with the proposed formula. Therefore, techniques for measurement of CRVP are warranted. Recently, a new, method for measurement of this parameter without corneal contact has been introduced. Briefly, with this method, IOP is elevated until the vein collapses, which then equals CRVP. In the present study this technique will be applied in 12 healthy subjects to validate whether the values that are preset by the device correlate to measurements obtained with standard Goldmann applanation tonometry. For this purpose, IOP will be experimentally increased in steps of approximately 5mmHg until it reaches 40mmHg as measured by applanation tonometry. After a resting period of 30 minutes, IOP will be again increased stepwise to 40 mmHg while retinal vessel diameters will be monitored using dynamic vessel analyzer. During this session CRVP will be measured. After another resting period of 30 minutes IOP will be stepwise increased a third time and after each step OCT, OCT-A and OCT EDI will be performed.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP)

  15 Minutes

Study Arms (1)

IOPstim

EXPERIMENTAL

Device: IOPstim; Device: Suction Cup

Interventions

IOPstim DEVICE

IOPstim (IMEDOS, Jena, Germany) is a device exerting defined pressure to the sclera and hence increasing IOP.

IOPstim

Suction Cup DEVICE

Suction Cup is a device exerting defined suction to the clear and hence increasing IOP

IOPstim

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged between 18 and 35 years
• Non-smokers
• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
• Normal ophthalmic findings, ametropia \< 1 Dpt.

You may not qualify if:

• Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
• Treatment in the previous 3 weeks with any drug (except contraceptives)
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• Blood donation during the previous 3 weeks
• Pregnancy, planned pregnancy or lactating

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

Study Officials

• Gerhard Garhöfer, MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv.-Doz. Dr.

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: July 24, 2019
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

AU (1)