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Evaluation of non-invasive intracranial pressure technology for use in glaucoma

Evaluation of non-invasive intracranial pressure technology for use in glaucoma - Non invasive ICP measurement technology in glaucoma

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46482
Enrollment
60
Registered
2019-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Glaucoma POAG

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 50-75 years of age - Presence of DPOAEs and tympanometry in at least one ear - Group 1: Upright IOP of 21mmHg or lower (determined during the screening test) - Group 2: Diagnosed Glaucoma, upright IOP of 21mmHg or lower with or without IOP lowering treatment, and established disease progression rate based on perimetry - Sign the informed consent.

Exclusion criteria

Exclusion criteria: - Poor condition of both middle ears during the tympanometric test - No presence of DPOAEs - Abnormality of the middle ear or external auditory canal (sequelae of ear infections, cerumen, sequelae of intervention on the tympanic membrane). - For healthy controls, any eye disease or family history of glaucoma. This will be determined by form F1 and the ophthalmologic screening described in section 2 of C1 (reseach protocol).

Design outcomes

Primary

MeasureTime frame
Ear absorbance as a function of posture : Postures which provoked high ICP increase perilymphatic pressure which displaces the stapes outward from the oval window, when this happen we can see a smaller absorbance. We should be able to repositioned the stapes using positive air pressure through the ear canal making the absorbance curve equal to the upright position curve and having the same ICP (normal iCP) that in this position. In the case of low ICP, perilymphatic pressure decrease and displaces the stapes inward of the oval window which should produce a bigger absorbance. We hypothesize that should be used negative pressure by the ear canal for repositioned the stapes in this case. Necessary pressure (measured in daPa) to repositioned the stapes (putting at the same place that upright position, that mean in a normal ICP) is going to be register in every subject an compared with each group making a t-student test.

Secondary

MeasureTime frame
Phase of DPOAEs as a function of posture.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)