NCT03014349

Brief Summary

The purpose of this study is to evaluate the reproducibility of tonometry in the Goldmann applanation apparatus and pneumatic in the water drinking test.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

December 9, 2016

Last Update Submit

January 6, 2017

Conditions

Keywords

GlaucomaOcular hypertension

Outcome Measures

Primary Outcomes (2)

  • Water drinking test and its reproducibility in Goldmann applanation tonometry

    Six months

  • Water drinking test and its reproducibility in pneumatic tonometry

    Six months

Study Arms (1)

primary open-angle glaucoma and/or glaucoma suspects

Individuals with primary open-angle glaucoma and/or glaucoma suspects, selected from the electronic records of the VER Hospital. The following variables will be observed: gender, age, race, systemic diseases, intraocular pressure, type of glaucoma, complementary exams and degree of evolution. All patients were given a complete ophthalmologic examination, including Goldmann and pneumatic tonometry.

Other: Analysis of medical records

Interventions

Individuals with primary open-angle glaucoma and/or glaucoma suspects, selected from the electronic records of the VER Hospital. The following variables will be observed: gender, age, race, systemic diseases, intraocular pressure, type of glaucoma, complementary exams and degree of evolution. All patients were given a complete ophthalmologic examination, including Goldmann and pneumatic tonometry.

primary open-angle glaucoma and/or glaucoma suspects

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be composed of individuals with primary open-angle glaucoma and/or glaucoma suspects

You may qualify if:

  • Older than 18 years
  • Intraocular pressure greater than 21 mmhg
  • Optic neuropathy more than 0.5
  • CampimetryPerimetric suggestive of glaucoma

You may not qualify if:

  • Were patients under 18 years of age
  • Incomplete data in electronic records
  • Had previous ophthalmologic surgeries or other non-glaucoma-related ophthalmic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Wachtl J, Toteberg-Harms M, Frimmel S, Kniestedt C. [Evaluation of correction formulas for tonometry : The Goldmann applanation tonometry in approximation to dynamic contour tonometry]. Ophthalmologe. 2017 Aug;114(8):716-721. doi: 10.1007/s00347-016-0409-3. German.

    PMID: 27921133BACKGROUND
  • Sakata R, Aihara M, Murata H, Saito H, Iwase A, Yasuda N, Araie M. Intraocular pressure change over a habitual 24-hour period after changing posture or drinking water and related factors in normal tension glaucoma. Invest Ophthalmol Vis Sci. 2013 Aug 7;54(8):5313-20. doi: 10.1167/iovs.13-11792.

    PMID: 23821194BACKGROUND
  • Medina FM, Rodrigues FK, Filho Pde T, Matsuo T, Vasconcellos JP, Costa VP. Reproducibility of water drinking test performed at different times of the day. Arq Bras Oftalmol. 2009 May-Jun;72(3):283-90. doi: 10.1590/s0004-27492009000300002.

    PMID: 19668954BACKGROUND
  • Meirelles SH, Yamane R, Alvares RM, Botelho PB, Morais FB, Moreira PB, Dantas AM, de Moraes Junior HV. [Comparative study between diurnal intraocular pressure curve and the association of ambulatory intraocular pressure curve with the water-drinking test in open angle glaucoma, normal tension glaucoma and normal eyes]. Arq Bras Oftalmol. 2007 May-Jun;70(3):471-9. doi: 10.1590/s0004-27492007000300015. Portuguese.

    PMID: 17768555BACKGROUND
  • Medeiros FA, Sample PA, Zangwill LM, Bowd C, Aihara M, Weinreb RN. Corneal thickness as a risk factor for visual field loss in patients with preperimetric glaucomatous optic neuropathy. Am J Ophthalmol. 2003 Nov;136(5):805-13. doi: 10.1016/s0002-9394(03)00484-7.

    PMID: 14597030BACKGROUND
  • Caiado RR, Badaro E, Kasahara N. Intraocular pressure fluctuation in healthy and glaucomatous eyes: a comparative analysis between diurnal curves in supine and sitting positions and the water drinking test. Arq Bras Oftalmol. 2014 Oct;77(5):288-292. doi: 10.5935/0004-2749.20140073. Epub 2014 Sep 1.

    PMID: 25494373BACKGROUND
  • Regev G, Harris A, Siesky B, Shoshani Y, Egan P, Moss A, Zalish M, WuDunn D, Ehrlich R. Goldmann applanation tonometry and dynamic contour tonometry are not correlated with central corneal thickness in primary open angle glaucoma. J Glaucoma. 2011 Jun-Jul;20(5):282-6. doi: 10.1097/IJG.0b013e3181e66498.

    PMID: 20577097BACKGROUND
  • Guler M, Bilak S, Bilgin B, Simsek A, Capkin M, Hakim Reyhan A. Comparison of Intraocular Pressure Measurements Obtained by Icare PRO Rebound Tonometer, Tomey FT-1000 Noncontact Tonometer, and Goldmann Applanation Tonometer in Healthy Subjects. J Glaucoma. 2015 Oct-Nov;24(8):613-8. doi: 10.1097/IJG.0000000000000132.

    PMID: 25264986BACKGROUND
  • Quaranta L, Konstas AG, Rossetti L, Garcia-Feijoo J, O'Brien C, Nasr MB, Fogagnolo P, Demos CM, Stewart JA, Stewart WC. Untreated 24-h intraocular pressures measured with Goldmann applanation tonometry vs nighttime supine pressures with Perkins applanation tonometry. Eye (Lond). 2010 Jul;24(7):1252-8. doi: 10.1038/eye.2009.300. Epub 2009 Dec 4.

    PMID: 19960033BACKGROUND

MeSH Terms

Conditions

Ocular HypertensionGlaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ophthalmologist

Study Record Dates

First Submitted

December 9, 2016

First Posted

January 9, 2017

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

November 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share