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OpenTrials
Completed

NCT Number: NCT01998568

The Intraocular Pressure Measured by Different Tonometers in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraocular pressure measurement

Other

Using different tonometers for intraocular pressure measurement

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

The Variation of the Intraocular Pressure Measured by Different Tonometers in Patients With Clinical Corneal Edema

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2013
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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