Intraocular PressureNCT01998568
The Intraocular Pressure Measured by Different Tonometers in Corneal Edema
An observational study of Intraocular Pressure and Corneal Edema, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The investigators conduct this study to access the effect of corneal edema (the investigators are particularly interested in those who have the clinical central corneal edema) on the variation of intraocular pressure values measured by 3 commercial-available tonometers compare to the current gold standard tonometer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure, Corneal Edema
- What is being tested?
- Intraocular pressure measurement
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2013to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have a clinical central corneal edema after clear cornea phacoemulsification and intraocular lens implantation
Who may be able to join
- Age more than 18 year-old
- Patients who have a clinical central corneal edema after clear cornea phacoemulsification and intraocular lens implantation
- Agree to participate in the study and willing to sign an informed consent
Who cannot join
- Combined phacoemulsification and trabeculectomy
- Clear cornea phacoemulsification that has suture on the cornea
- Previous history of intraocular surgery, ocular trauma prior to phacoemulsification
- Vitrectomized eye
- History of glaucoma or ocular hypertension or using IOP lowering medication
- History of diabetic retinopathy staged as severe non-proliferative or worse
Show all 17Show fewer
- Pregnant or breast-feeding women
- History of refractive surgery or any keratoplastic procedure
- Corneal opacities or diseases making no suitable tonometry
- Severe dry eye syndrome
- Wears contact lenses
- Astigmatism higher than 2.5 diopters
- Microphthalmos or buphthalmos
- Subjects with having poor or eccentric fixation or nystagmus
- Excessive eye squeezing
- Known allergy to topical anesthesia
- Known allergy to fluorescein solution
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: The Variation of the Intraocular Pressure Measured by Different Tonometers in Patients With Clinical Corneal Edema
The investigators conduct this study to access the effect of corneal edema (the investigators are particularly interested in those who have the clinical central corneal edema) on the variation of intraocular pressure values measured by 3 commercial-available tonometers compare to the current gold standard tonometer; Goldmann applanation tonometer.
Read the detailed description
Previous published articles reported on the effect of corneal edema on the accuracy of tonometry were performed in enucleated cadaver eyes, or contact lens-induced corneal edema eyes. Thus, it remains unclear as to how the clinical corneal edema that is found in routine clinical practice will affect the variation of intraocular pressure measurement using the standard Goldmann applanation tonometer and other more modern tonometers such as the dynamic contour tonometer, the iCare, and the Tonopen.
- Conditions
- Intraocular Pressure, Corneal Edema
- Being tested
- Intraocular pressure measurement
- Keywords
- Intraocular pressure, Corneal edema, Tonometer, Dynamic contour tonometer, Tonopen, iCare, Goldmann applanation
- Medical subject headings
- Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressure measurementOther
Using different tonometers for intraocular pressure measurement
| Study group | Role | What they receive |
|---|---|---|
| Corneal edema | Intraocular pressure measurement Receives: Other: Intraocular pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
The intraocular pressure measured by each tonometer compare with Goldmann applanation tonometer (When measure in eyes with corneal edema and when the edema is clinically resolve)
Measured: A day after cataract surgery and when the corneal edema is resolve (usually within 1-2 weeks post operatively)
Secondary outcomes (1)
Relationship between the central corneal thickness and intraocular pressure measured by each tonometer
The severity of corneal edema may affect the reliability of intraocular pressure measurement measured by different tonometers
Measured: A day after surgery (clinical corneal edema was detected) and within 1-2 weeks (resolution of edema)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weerawat Kiddee, Prince of Songkla University
- Investigators
- Weerawat Kiddee, MD, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998568
- Sponsor's protocol ID
- 56-451-02-1
- Status last verified
- Nov 2017
- First submitted
- 23 Nov 2013
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Variation of the Intraocular Pressure Measured by Different Tonometers in Patients With Clinical Corneal Edema
- ClinicalTrials.gov ID
- NCT01998568
- Acronym / sponsor ID
- 56-451-02-1
- Conditions
- Intraocular Pressure, Corneal Edema
- Keywords
- Intraocular pressure, Corneal edema, Tonometer, Dynamic contour tonometer, Tonopen, iCare, Goldmann applanation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Dec 2013 (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 investigators conduct this study to access the effect of corneal edema (the investigators are particularly interested in those who have the clinical central corneal edema) on the variation of intraocular pressure values measured by 3 commercial-available tonometers compare to the current gold standard tonometer; Goldmann applanation tonometer.
Detailed description
Previous published articles reported on the effect of corneal edema on the accuracy of tonometry were performed in enucleated cadaver eyes, or contact lens-induced corneal edema eyes. Thus, it remains unclear as to how the clinical corneal edema that is found in routine clinical practice will affect the variation of intraocular pressure measurement using the standard Goldmann applanation tonometer and other more modern tonometers such as the dynamic contour tonometer, the iCare, and the Tonopen.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal edema | – | Other: Intraocular pressure measurementIntraocular pressure measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a clinical central corneal edema after clear cornea phacoemulsification and intraocular lens implantation
Key inclusion criteria (3 listed)
- Age more than 18 year-old
- Patients who have a clinical central corneal edema after clear cornea phacoemulsification and intraocular lens implantation
- Agree to participate in the study and willing to sign an informed consent
Key exclusion criteria (17 listed)
- Combined phacoemulsification and trabeculectomy
- Clear cornea phacoemulsification that has suture on the cornea
- Previous history of intraocular surgery, ocular trauma prior to phacoemulsification
- Vitrectomized eye
- History of glaucoma or ocular hypertension or using IOP lowering medication
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 |
|---|---|---|
| Intraocular pressure measurementUsing different tonometers for intraocular pressure measurement | Other | Corneal edema |
Primary outcome
Intraocular pressure
Time frame: A day after cataract surgery and when the corneal edema is resolve (usually within 1-2 weeks post operatively)
The intraocular pressure measured by each tonometer compare with Goldmann applanation tonometer (When measure in eyes with corneal edema and when the edema is clinically resolve)
1 secondary outcome
Relationship between the central corneal thickness and intraocular pressure measured by each tonometer
Time frame: A day after surgery (clinical corneal edema was detected) and within 1-2 weeks (resolution of edema)
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 6 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Weerawat Kiddee, MD principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure and Corneal Edema, run by Prince of Songkla University at 1 site in Thailand.
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 3 inclusion and 17 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Intraocular pressure (time frame: A day after cataract surgery and when the corneal edema is resolve (usually within 1-2 weeks post operatively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2017.