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

NCT ID: NCT02843971

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intraocular Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Group Type EXPERIMENTAL

Intraocular pressure measurement with the Sensimed triggerfish Device

Intervention Type DEVICE

Interventions

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Intraocular pressure measurement with the Sensimed triggerfish Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
* Aged over 18 years
* No previous ophthalmic conditions
* Spherical equivalent from - 6 to +3 diopters

Exclusion Criteria

* Contact lens use
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florent APTEL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology CHU de Grenoble/University Hospital of Grenoble

Locations

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University Hospital of Grenoble

Grenoble, , France

Site Status

Countries

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France

References

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Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.

Reference Type BACKGROUND
PMID: 16488940 (View on PubMed)

Guo L, Moss SE, Alexander RA, Ali RR, Fitzke FW, Cordeiro MF. Retinal ganglion cell apoptosis in glaucoma is related to intraocular pressure and IOP-induced effects on extracellular matrix. Invest Ophthalmol Vis Sci. 2005 Jan;46(1):175-82. doi: 10.1167/iovs.04-0832.

Reference Type BACKGROUND
PMID: 15623771 (View on PubMed)

Fuchshofer R. The pathogenic role of transforming growth factor-beta2 in glaucomatous damage to the optic nerve head. Exp Eye Res. 2011 Aug;93(2):165-9. doi: 10.1016/j.exer.2010.07.014. Epub 2010 Aug 12.

Reference Type BACKGROUND
PMID: 20708611 (View on PubMed)

Leske MC, Wu SY, Hennis A, Honkanen R, Nemesure B; BESs Study Group. Risk factors for incident open-angle glaucoma: the Barbados Eye Studies. Ophthalmology. 2008 Jan;115(1):85-93. doi: 10.1016/j.ophtha.2007.03.017. Epub 2007 Jul 16.

Reference Type BACKGROUND
PMID: 17629563 (View on PubMed)

Le A, Mukesh BN, McCarty CA, Taylor HR. Risk factors associated with the incidence of open-angle glaucoma: the visual impairment project. Invest Ophthalmol Vis Sci. 2003 Sep;44(9):3783-9. doi: 10.1167/iovs.03-0077.

Reference Type BACKGROUND
PMID: 12939292 (View on PubMed)

Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Kass MA. The Ocular Hypertension Treatment Study: baseline factors that predict the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):714-20; discussion 829-30. doi: 10.1001/archopht.120.6.714.

Reference Type BACKGROUND
PMID: 12049575 (View on PubMed)

European Glaucoma Prevention Study (EGPS) Group; Miglior S, Pfeiffer N, Torri V, Zeyen T, Cunha-Vaz J, Adamsons I. Predictive factors for open-angle glaucoma among patients with ocular hypertension in the European Glaucoma Prevention Study. Ophthalmology. 2007 Jan;114(1):3-9. doi: 10.1016/j.ophtha.2006.05.075. Epub 2006 Oct 27.

Reference Type BACKGROUND
PMID: 17070596 (View on PubMed)

Sommer A, Tielsch JM, Katz J, Quigley HA, Gottsch JD, Javitt J, Singh K. Relationship between intraocular pressure and primary open angle glaucoma among white and black Americans. The Baltimore Eye Survey. Arch Ophthalmol. 1991 Aug;109(8):1090-5. doi: 10.1001/archopht.1991.01080080050026.

Reference Type BACKGROUND
PMID: 1867550 (View on PubMed)

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. doi: 10.1001/archopht.120.6.701.

Reference Type BACKGROUND
PMID: 12049574 (View on PubMed)

Miglior S, Zeyen T, Pfeiffer N, Cunha-Vaz J, Torri V, Adamsons I; European Glaucoma Prevention Study (EGPS) Group. Results of the European Glaucoma Prevention Study. Ophthalmology. 2005 Mar;112(3):366-75. doi: 10.1016/j.ophtha.2004.11.030.

Reference Type BACKGROUND
PMID: 15745761 (View on PubMed)

The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators. Am J Ophthalmol. 2000 Oct;130(4):429-40. doi: 10.1016/s0002-9394(00)00538-9.

Reference Type BACKGROUND
PMID: 11024415 (View on PubMed)

Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.

Reference Type BACKGROUND
PMID: 12365904 (View on PubMed)

The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol. 1998 Oct;126(4):498-505. doi: 10.1016/s0002-9394(98)00272-4.

Reference Type BACKGROUND
PMID: 9780094 (View on PubMed)

Mosaed S, Liu JH, Weinreb RN. Correlation between office and peak nocturnal intraocular pressures in healthy subjects and glaucoma patients. Am J Ophthalmol. 2005 Feb;139(2):320-4. doi: 10.1016/j.ajo.2004.09.062.

Reference Type BACKGROUND
PMID: 15733994 (View on PubMed)

Liu JH, Kripke DF, Hoffman RE, Twa MD, Loving RT, Rex KM, Gupta N, Weinreb RN. Nocturnal elevation of intraocular pressure in young adults. Invest Ophthalmol Vis Sci. 1998 Dec;39(13):2707-12.

Reference Type BACKGROUND
PMID: 9856781 (View on PubMed)

Hara T, Hara T, Tsuru T. Increase of peak intraocular pressure during sleep in reproduced diurnal changes by posture. Arch Ophthalmol. 2006 Feb;124(2):165-8. doi: 10.1001/archopht.124.2.165.

Reference Type BACKGROUND
PMID: 16476884 (View on PubMed)

Asrani S, Zeimer R, Wilensky J, Gieser D, Vitale S, Lindenmuth K. Large diurnal fluctuations in intraocular pressure are an independent risk factor in patients with glaucoma. J Glaucoma. 2000 Apr;9(2):134-42. doi: 10.1097/00061198-200004000-00002.

Reference Type BACKGROUND
PMID: 10782622 (View on PubMed)

Nouri-Mahdavi K, Hoffman D, Coleman AL, Liu G, Li G, Gaasterland D, Caprioli J; Advanced Glaucoma Intervention Study. Predictive factors for glaucomatous visual field progression in the Advanced Glaucoma Intervention Study. Ophthalmology. 2004 Sep;111(9):1627-35. doi: 10.1016/j.ophtha.2004.02.017.

Reference Type BACKGROUND
PMID: 15350314 (View on PubMed)

Caprioli J, Coleman AL. Intraocular pressure fluctuation a risk factor for visual field progression at low intraocular pressures in the advanced glaucoma intervention study. Ophthalmology. 2008 Jul;115(7):1123-1129.e3. doi: 10.1016/j.ophtha.2007.10.031. Epub 2008 Feb 20.

Reference Type BACKGROUND
PMID: 18082889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10549652 (View on PubMed)

Sit AJ, Weinreb RN, Crowston JG, Kripke DF, Liu JH. Sustained effect of travoprost on diurnal and nocturnal intraocular pressure. Am J Ophthalmol. 2006 Jun;141(6):1131-3. doi: 10.1016/j.ajo.2006.01.049.

Reference Type BACKGROUND
PMID: 16765686 (View on PubMed)

Romanet JP, Maurent-Palombi K, Noel C, Bourdon L, Pepin JL, Mouillon M, Buguet A. [Nyctohemeral variations in intraocular pressure]. J Fr Ophtalmol. 2004 Sep;27 Spec No 2:2S19-2S26. French.

Reference Type BACKGROUND
PMID: 15314571 (View on PubMed)

Hjortdal JO, Jensen PK. In vitro measurement of corneal strain, thickness, and curvature using digital image processing. Acta Ophthalmol Scand. 1995 Feb;73(1):5-11. doi: 10.1111/j.1600-0420.1995.tb00004.x.

Reference Type BACKGROUND
PMID: 7627759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21216796 (View on PubMed)

De Smedt S, Mermoud A, Schnyder C. 24-hour intraocular pressure fluctuation monitoring using an ocular telemetry Sensor: tolerability and functionality in healthy subjects. J Glaucoma. 2012 Oct-Nov;21(8):539-44. doi: 10.1097/IJG.0b013e31821dac43.

Reference Type BACKGROUND
PMID: 21602707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23229696 (View on PubMed)

Freiberg FJ, Lindell J, Thederan LA, Leippi S, Shen Y, Klink T. Corneal thickness after overnight wear of an intraocular pressure fluctuation contact lens sensor. Acta Ophthalmol. 2012 Nov;90(7):e534-9. doi: 10.1111/j.1755-3768.2012.02495.x. Epub 2012 Sep 13.

Reference Type BACKGROUND
PMID: 22974389 (View on PubMed)

Pajic B, Pajic-Eggspuchler B, Haefliger I. Continuous IOP fluctuation recording in normal tension glaucoma patients. Curr Eye Res. 2011 Dec;36(12):1129-38. doi: 10.3109/02713683.2011.608240. Epub 2011 Oct 6.

Reference Type BACKGROUND
PMID: 21978205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23139273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23524857 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 23848265 (View on PubMed)

Mottet B, Aptel F, Romanet JP, Hubanova R, Pepin JL, Chiquet C. 24-hour intraocular pressure rhythm in young healthy subjects evaluated with continuous monitoring using a contact lens sensor. JAMA Ophthalmol. 2013 Dec;131(12):1507-16. doi: 10.1001/jamaophthalmol.2013.5297.

Reference Type BACKGROUND
PMID: 24158696 (View on PubMed)

Danesh-Meyer HV. The water-drinking test: the elegance of simplicity. Clin Exp Ophthalmol. 2008 May;36(4):301-3. doi: 10.1111/j.1442-9071.2008.01782.x. No abstract available.

Reference Type BACKGROUND
PMID: 18700912 (View on PubMed)

Friberg TR, Sanborn G, Weinreb RN. Intraocular and episcleral venous pressure increase during inverted posture. Am J Ophthalmol. 1987 Apr 15;103(4):523-6. doi: 10.1016/s0002-9394(14)74275-8.

Reference Type BACKGROUND
PMID: 3565513 (View on PubMed)

Diestelhorst M, Krieglstein GK. The effect of the water-drinking test on aqueous humor dynamics in healthy volunteers. Graefes Arch Clin Exp Ophthalmol. 1994 Mar;232(3):145-7. doi: 10.1007/BF00176783.

Reference Type BACKGROUND
PMID: 8188063 (View on PubMed)

Hayreh SS. Acute occlusive disorders of the choroidal vasculature. Int Ophthalmol. 1983 Feb;6(2):139-48. doi: 10.1007/BF00127642. No abstract available.

Reference Type BACKGROUND
PMID: 6682094 (View on PubMed)

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 Exp Ophthalmol. 2008 May;36(4):312-5. doi: 10.1111/j.1442-9071.2008.01765.x.

Reference Type BACKGROUND
PMID: 18700916 (View on PubMed)

MILLER D. THE RELATIONSHIP BETWEEN DIURNAL TENSION VARIATION AND THE WATER-DRINKING TEST. Am J Ophthalmol. 1964 Aug;58:243-6. doi: 10.1016/0002-9394(64)91571-5. No abstract available.

Reference Type BACKGROUND
PMID: 14204331 (View on PubMed)

Frankelson EN. The role of the water test in evaluation of glaucoma control. Can J Ophthalmol. 1974 Oct;9(4):408-10. No abstract available.

Reference Type BACKGROUND
PMID: 4473065 (View on PubMed)

Chen CH, Lu DW, Chang CJ, Chiang CH, Chou PI. The application of water drinking test on the evaluation of trabeculectomy patency. J Ocul Pharmacol Ther. 2000 Feb;16(1):37-42. doi: 10.1089/jop.2000.16.37.

Reference Type BACKGROUND
PMID: 10673129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24240887 (View on PubMed)

Aptel F, Tamisier R, Pepin JL, Mottet B, Hubanova R, Romanet JP, Chiquet C. Hourly awakening vs continuous contact lens sensor measurements of 24-hour intraocular pressure: effect on sleep macrostructure and intraocular pressure rhythm. JAMA Ophthalmol. 2014 Oct;132(10):1232-8. doi: 10.1001/jamaophthalmol.2014.1761.

Reference Type BACKGROUND
PMID: 25074578 (View on PubMed)

Susanna R Jr, Hatanaka M, Vessani RM, Pinheiro A, Morita C. Correlation of asymmetric glaucomatous visual field damage and water-drinking test response. Invest Ophthalmol Vis Sci. 2006 Feb;47(2):641-4. doi: 10.1167/iovs.04-0268.

Reference Type BACKGROUND
PMID: 16431962 (View on PubMed)

Other Identifiers

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38RC14.317

Identifier Type: -

Identifier Source: org_study_id

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