Evaluation of the Water Drinking Test Response in Supine and Sitting Position Using the Continuous Measurement Device Sensimed Triggerfish Intraocular Pressure in Healthy Subjects

Intraocular Pressure Clinical Trial

— PIO-WDT  

Official title:

Evaluation of the Water Drinking Test Response in Supine and Sitting Position Using the Continuous Intraocular Pressure Measurement Device Sensimed Triggerfish in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843971
• Other study ID #: 38RC14.317
• Status: Completed
• Phase: N/A
• First received: January 13, 2015
• Last updated: July 22, 2016
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Monocentric, prospective study, comparison of the water drinking test response in the supine and in the sitting position using the intraocular pressure monitoring device Sensimed Triggerfish in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Healthy subjects

• Aged over 18 years

• No previous ophthalmic conditions

• Spherical equivalent from - 6 to +3 diopters

Exclusion Criteria:

• Contact lens use

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Device:
• Intraocular pressure measurement with the Sensimed triggerfish Device

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (43)

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Hubanova R, Aptel F, Chiquet C, Mottet B, Romanet JP. Effect of overnight wear of the Triggerfish(®) sensor on corneal thickness measured by Visante(®) anterior segment optical coherence tomography. Acta Ophthalmol. 2014 Mar;92(2):e119-23. doi: 10.1111/aos.12241. Epub 2013 Jul 15. — View Citation

Hubanova R, Aptel F, Zhou T, Arnol N, Romanet JP, Chiquet C. Comparison of intraocular pressure measurements with the Reichert Pt100, the Keeler Pulsair Intellipuff portable noncontact tonometers, and Goldmann applanation tonometry. J Glaucoma. 2015 Jun-Jul;24(5):356-63. doi: 10.1097/01.ijg.0000435776.99193.41. — View Citation

Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. — View Citation

Kumar RS, de Guzman MH, Ong PY, Goldberg I. Does peak intraocular pressure measured by water drinking test reflect peak circadian levels? A pilot study. Clin Experiment Ophthalmol. 2008 May;36(4):312-5. doi: 10.1111/j.1442-9071.2008.01765.x. — View Citation

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Liu JH, Kripke DF, Twa MD, Hoffman RE, Mansberger SL, Rex KM, Girkin CA, Weinreb RN. Twenty-four-hour pattern of intraocular pressure in the aging population. Invest Ophthalmol Vis Sci. 1999 Nov;40(12):2912-7. — View Citation

Lorenz K, Korb C, Herzog N, Vetter JM, Elflein H, Keilani MM, Pfeiffer N. Tolerability of 24-hour intraocular pressure monitoring of a pressure-sensitive contact lens. J Glaucoma. 2013 Apr-May;22(4):311-6. doi: 10.1097/IJG.0b013e318241b874. — View Citation

Mansouri K, Liu JH, Weinreb RN, Tafreshi A, Medeiros FA. Analysis of continuous 24-hour intraocular pressure patterns in glaucoma. Invest Ophthalmol Vis Sci. 2012 Dec 13;53(13):8050-6. doi: 10.1167/iovs.12-10569. — View Citation

Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/jamaophthalmol.2013.1350. — View Citation

Mansouri K, Shaarawy T. Continuous intraocular pressure monitoring with a wireless ocular telemetry sensor: initial clinical experience in patients with open angle glaucoma. Br J Ophthalmol. 2011 May;95(5):627-9. doi: 10.1136/bjo.2010.192922. Epub 2011 Jan 7. — View Citation

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of intraocular pressure while lying down	Peak IOP defined by the maximum level reached Peak period defined by the time from the ingestion of water and the occurrence of the IOP; and Time to get back to the initial pressure, as measured with the sensimed triggerfish device.; On one eye and the lens is inserted on the other eye.	30 minutes	No
Primary	Measure of intraocular pressure while sitting	Peak IOP defined by the maximum level reached; Peak period defined by the time from the ingestion of water and the occurrence of the IOP; and Time to get back to the initial pressure, as measured with the sensimed triggerfish device.; On one eye and the lens is inserted on the other eye.	30 minutes	No
Primary	Measure of intraocular pressure on the eye without the lens.	Peak IOP defined by the maximum level reached; Peak period defined by the time from the ingestion of water and the occurrence of the IOP; and Time to get back to the initial pressure, as measured with the non-contact tonometer.	30 minutes	No
Primary	Mesure of intraocular pressure on the eye	Six results. Without the lens each 15 minutes. After drinking 1 L of water.	One hour and a half	No
Primary	Mesure of intraocular pressure on the eye without the lens each 30 minutes.	Two results. After drinking 1 L of water.	One hour	No