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Assessing a new technique for Intracranial pressure Recording Without Invasion or Needles

Assessing Intracranial Pressure Recording Without Invasion or Needles using retinal photoplethysmography in adults.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001040550
Acronym
IRWIN
Enrollment
50
Registered
2024-08-28
Start date
2024-09-13
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We have developed a non-Invasive Intracranial Pressure Measurement via a Modified Photoplethysmography Technique. We have published several papers, demonstrating the accuracy of the system, which was large and unwieldy. We have shrunk the system down so that it can now be held by an examiners hand and used in patients who were bedbound, or have other medical problems. We wish to measure the accuracy and utility of such a portable photoplethysmographic system in assessing intracranial pressure. If the system is accurate, then it could save many patients from requiring invasive lumbar puncture or external ventricular drain when they have conditions where elevated intracranial pressure is thought to be a factor.

Interventions

All subjects will need to have their pupils dilated using Tropicamide 1% 2 drops 5 min apart, so that we can view the retina and take the necessary video photographs. Dilation does blur the vision for 2 hours and so subjects will be advised not to drive for 2 hours after dilation. We then apply a contact lens on the eye after topical anaesthesia (Oxyprobucaine 2%) so that the retina can be viewed and intraocular pressure altered. Multiple video-recordings of the retina and retinal vessels are

All subjects will need to have their pupils dilated using Tropicamide 1% 2 drops 5 min apart, so that we can view the retina and take the necessary video photographs. Dilation does blur the vision for 2 hours and so subjects will be advised not to drive for 2 hours after dilation. We then apply a contact lens on the eye after topical anaesthesia (Oxyprobucaine 2%) so that the retina can be viewed and intraocular pressure altered. Multiple video-recordings of the retina and retinal vessels are taken, which are later analysed. The contact lens is made of medical grade polymethyl methacrylate, lathed and polished to have zero optical power. A standard retinal camera is attached behind the contact lens and records video recordings of the central retinal vessels. The pupil dilation takes 20 minutes and the anaesthesia of the cornea takes one minute with the video recording taking 20 to 60 minutes. There is no follow-up required because all of the measurements needed are taken at the one sitting. So there is no need to monitor adherence. The only intervention is the dilation and the installation of the anaesthetic drops to allow contact lens imaging to take good quality video recordings of the retina. The new technique uses photoplethysmography, which is a system for measuring pulsation amplitudes in the retinal vessels. We have invented this technique and have published five papers, illustrating and validating the technique and demonstrating its accuracy in terms of predicting intracranial pressure. The system has been developed on a large benchtop optical set up. With this study, we have compressed the optical elements and camera into a small portable system which can be handheld. The underlying optical and analytical system with contact lens remains exactly the same, but the form factor has been reduced in size to allow an operator to hold the instrument in one hand.

Sponsors

Lions Eye Institute
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Suspected raised ICP, consideration of need for either lumbar puncture, direct brain (eg EVD) pressure monitoring or revision of Ventricle-Perioneal (or other relevant) CSF shunt. Healthy volunteers can be enrolled to test optimal postural positioning for the contact lens photoplethysmography. No invasive ICP procedures would be performed.

Exclusion criteria

corneal eye disease, poor view of retina in both eyes.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026