Water Drinking Test and Its Reproducibility in Goldmann Applanation Tonometry and Pneumatic Tonometry (WDTRGP)

January 6, 2017 updated by: Rodrigo Egidio da Silva, VER Excelência em Oftalmologia
The purpose of this study is to evaluate the reproducibility of tonometry in the Goldmann applanation apparatus and pneumatic in the water drinking test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Glaucoma consists of a multifactorial disease caused by a deficiency in drainage of the aqueous humor, which may cause an increase in intraocular pressure (IOP), an impairment of the optic nerve and visual field changes. According to the most recent data , this disease is the second cause of blindness in the world (12.3%). An estimate indicates that, by 2020, there will be 79.6 million glaucomatous individuals in the world. The estimated prevalence of primary glaucoma in the Brazilian population was 3.4%, consisting of 2.4% open angle and 0.7% closed angle.

Glaucoma can be: open angle, angle-closure, congenital or secondary. Increased IOP is the major risk factor for glaucoma progression as well as its fluctuation (difference between the highest and lowest IOP measure) in primary open-angle glaucoma (POAG). In addition, age, family history, central corneal thickness, race, high myopia, hypermetropia, diabetes mellitus, hypertension and hypotension, gender, optic disc hemorrhages, suspected optic nerve excavation, and cardiovascular and cerebrovascular diseases.

The treatment depends on the classification of glaucoma, since in the POAG, the initial treatment is with topical monotherapy (ocular hypotensors). However, in some situations, drug treatment is not enough to stabilize the process of glaucomatous progression. In these cases, incisional surgery or laser treatment is necessary.

Trabeculectomy consists of an intervention to increase drainage of the aqueous humor, in order to control the IOP and prevent the progression of the disease. However, due to its complications, such as atalamia, hypotonia, the development of cataract and the risk of endophthalmitis, this procedure is indicated in the refractory cases to clinical and/or laser treatment. Thus, clinical treatment and trabeculoplasty are the treatments of choice. Trabeculoplasty is indicated in the cases of POAG, pseudoexfoliative, pigmented and in some cases of secondary and trabecular glaucoma visible to the gonioscopy.

The tonometer is the device used to detect IOP increase. Despite the existence of several models, Goldmann's applanation is considered the gold standard for this measurement, since it evaluates the force necessary to deform the surface of the cornea. This method is quite accurate, however, errors may occur in the result due to fluorescein patterns, very thick corneas, excessive pressure on the eyeball when holding the patient's eyelids or elevated corneal astigmatism without the adequate compensatory positioning of the planer.

The measurement of IOP can also be performed through another type of tonometer: non-contact, pneumatic or blow. It was first used in 1973 by Forbes and its advantages are: 1) no need for the use of eye drops, 2) it can be performed by people who are not doctors, 3) it has a low risk of contamination and 4) it can be used for screening programs. However, a study by Britt et al. showed the presence of lachrymal film dehiscence and the existence of microaerosol with the air blow, which would make this method not so aseptic.

According to the study, where the pneumatic tonometer was compared with that of Goldmann, the results obtained were: 50% of the evaluated eyes showed no differences between the two devices and in 85% they were between approximately 2 mmHg. In another study which compared the IOP values measured by the mentioned tonometers, it was verified that the pneumatic tonometer underestimates the IOP values, compared to Goldmann, in thin corneas; however, there is no significant difference between the measurements of the two tonometers in thick corneas.

The Water Drinking Test (WDT) is a propaedeutic widely used to evaluate the maximum intraocular pressure (IOP) and its fluctuation. These data are extremely important for the expected result in relation to the reproducibility of the exams, since in the study , showed that the WDT can be used to estimate the peak and diurnal fluctuation of supine IOP in the simplified daily stress curve (another method for the same purpose of the WDT) in patients under treatment for glaucoma.

Glaucoma is a serious eye health problem, as it has a high incidence and prevalence worldwide and is the leading cause of irreversible blindness in the world. Therefore, it is extremely important to perform tests that will detect altered IOP values.

The IOP values obtained over a 24 hour period are important data, since they are required to control and conduct the treatment of glaucoma. In the past, the WDT has often been used to diagnose patients with this pathology. Due to a series of studies,it was found that the WDT can not be used as a diagnostic test, but as a tool to evaluate changes in IOP peaks. In addition, a comparison of reproducibility between devices will facilitate a better evaluation, speed, safety and efficacy in the treatment, contributing to increase the quality of life of the patient and also to guide other studies in this area.

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Water drinking test and its reproducibility in Goldmann applanation tonometry
Time Frame: Six months
Six months
Water drinking test and its reproducibility in pneumatic tonometry
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 9, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEREO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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