The Intraocular Pressure Measured by Different Tonometers in Corneal Edema

Intraocular Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998568
• Other study ID #: 56-451-02-1
• Status: Completed
• Phase: N/A
• First received: November 23, 2013
• Last updated: November 1, 2017
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2017
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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; Goldmann applanation tonometer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Edema
• Edema
• Intraocular Pressure

Intervention

Other:
• Intraocular pressure measurement
Using different tonometers for intraocular pressure measurement

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)