Glaucoma SuspectWDTRGPNCT03014349
Water Drinking Test and Its Reproducibility in Goldmann Applanation Tonometry and Pneumatic Tonometry
An observational study of Glaucoma Suspect, run by VER Excelência em Oftalmologia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glaucoma Suspect
- What is being tested?
- Analysis of medical records
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be composed of individuals with primary open-angle glaucoma and/or glaucoma suspects
Who may be able to join
- Older than 18 years
- Intraocular pressure greater than 21 mmhg
- Optic neuropathy more than 0.5
- CampimetryPerimetric suggestive of glaucoma
Who cannot join
- Were patients under 18 years of age
- Incomplete data in electronic records
- Had previous ophthalmologic surgeries or other non-glaucoma-related ophthalmic diseases.
About this study
The purpose of this study is to evaluate the reproducibility of tonometry in the Goldmann applanation apparatus and pneumatic in the water drinking test.
Read the 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.
- Conditions
- Glaucoma Suspect
- Being tested
- Analysis of medical records
- Keywords
- Glaucoma, Ocular hypertension
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of medical recordsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Analysis of medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Water drinking test and its reproducibility in Goldmann applanation tonometry
Measured: Six months
Water drinking test and its reproducibility in pneumatic tonometry
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Glaucoma SuspectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- VER Excelência em Oftalmologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Egidio da Silva, VER Excelência em Oftalmologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014349
- Sponsor's protocol ID
- VEREO
- Acronym
- WDTRGP
- Status last verified
- Jan 2017
- First submitted
- 9 Dec 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27921133Sakata 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.
PubMed 23821194Medina 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.
PubMed 19668954Meirelles 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.
PubMed 17768555Medeiros 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.
PubMed 14597030Caiado 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.
PubMed 25494373Regev 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.
PubMed 20577097Guler 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.
PubMed 25264986Quaranta 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.
PubMed 19960033
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Drinking Test and Its Reproducibility in Goldmann Applanation Tonometry and Pneumatic Tonometry
- ClinicalTrials.gov ID
- NCT03014349
- Acronym / sponsor ID
- WDTRGP / VEREO
- Conditions
- Glaucoma Suspect
- Keywords
- Glaucoma, Ocular hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- VER Excelência em OftalmologiaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the reproducibility of tonometry in the Goldmann applanation apparatus and pneumatic in the water drinking test.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primary open-angle glaucoma and/or glaucoma suspects | – | Other: Analysis of medical recordsIndividuals 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of individuals with primary open-angle glaucoma and/or glaucoma suspects
Key inclusion criteria (4 listed)
- Older than 18 years
- Intraocular pressure greater than 21 mmhg
- Optic neuropathy more than 0.5
- CampimetryPerimetric suggestive of glaucoma
Key exclusion criteria (3 listed)
- Were patients under 18 years of age
- Incomplete data in electronic records
- Had previous ophthalmologic surgeries or other non-glaucoma-related ophthalmic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of medical recordsIndividuals 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 | primary open-angle glaucoma and/or glaucoma suspects |
Primary outcome
Water drinking test and its reproducibility in Goldmann applanation tonometry
Time frame: Six months
Water drinking test and its reproducibility in pneumatic tonometry
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Background: PubMed 27921133Wachtl 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.
- Background: PubMed 23821194Sakata 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.
- Background: PubMed 19668954Medina 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.
- Background: PubMed 17768555Meirelles 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.
- Background: PubMed 14597030Medeiros 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.
- Background: PubMed 25494373Caiado 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.
- Background: PubMed 20577097Regev 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.
- Background: PubMed 25264986Guler 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.
- Background: PubMed 19960033Quaranta 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.
- Individual participant dataSharing planned: No
Related trials for Glaucoma Suspect
Not yet recruiting
Know Your Pressures NYC
Glaucoma, Hypertension
RecruitingPhase 4
Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects
Ocular Hypertension, Suspect Glaucoma
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 4
Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
Glaucoma, Open-Angle Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma Suspect, run by VER Excelência em Oftalmologia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Water drinking test and its reproducibility in Goldmann applanation tonometry (time frame: Six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014349, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.