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The Intraocular Pressure Measured by Different Tonometers in Corneal Edema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01998568
First Posted: December 2, 2013
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Weerawat Kiddee, Prince of Songkla University
  Purpose
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.

Condition Intervention
Intraocular Pressure Corneal Edema Other: Intraocular pressure measurement

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Variation of the Intraocular Pressure Measured by Different Tonometers in Patients With Clinical Corneal Edema

Resource links provided by NLM:


Further study details as provided by Weerawat Kiddee, Prince of Songkla University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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) ]
    The severity of corneal edema may affect the reliability of intraocular pressure measurement measured by different tonometers


Enrollment: 50
Study Start Date: November 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Corneal edema
Intraocular pressure measurement
Other: Intraocular pressure measurement
Using different tonometers for intraocular pressure measurement

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have a clinical central corneal edema after clear cornea phacoemulsification and intraocular lens implantation
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998568


Locations
Thailand
Faculty of Medicine, Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Weerawat Kiddee, MD Prince of Songkla University
  More Information

Responsible Party: Weerawat Kiddee, Doctor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01998568     History of Changes
Other Study ID Numbers: 56-451-02-1
First Submitted: November 23, 2013
First Posted: December 2, 2013
Last Update Posted: November 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Weerawat Kiddee, Prince of Songkla University:
Intraocular pressure
Corneal edema
Tonometer
Dynamic contour tonometer
Tonopen
iCare
Goldmann applanation

Additional relevant MeSH terms:
Edema
Corneal Edema
Signs and Symptoms
Corneal Diseases
Eye Diseases