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OpenTrials
Completed

NCT Number: NCT04044274

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

IOPstim

Device

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

Suction cup

Device

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

Primary outcomes

  1. Intraocular pressure (IOP)

    Time frame: 15 Minutes

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2019
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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