The Intraocular Pressure Measured by Different Tonometers in Corneal Edema

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure; Corneal Edema
• Intervention / Treatment: Other: 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Faculty of Medicine, Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have a clinical central corneal edema after clear cornea phacoemulsification and intraocular lens implantation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Corneal edema; Intraocular pressure measurement	Other: Intraocular pressure measurement; Using different tonometers for intraocular pressure measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	A day after cataract surgery and when the corneal edema is resolve (usually within 1-2 weeks post operatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A day after surgery (clinical corneal edema was detected) and within 1-2 weeks (resolution of edema)

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: November 23, 2013
• First Submitted That Met QC Criteria: November 29, 2013
• First Posted (ESTIMATE): December 2, 2013

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Intraocular pressure; Corneal edema; Goldmann applanation; Tonopen; Tonometer; iCare; Dynamic contour tonometer
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Edema; Corneal Edema
• Other Study ID Numbers: 56-451-02-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO