The Intraocular Pressure Measured by Different Tonometers in Corneal Edema

NCT01998568 | Completed DMC

• 1 other identifier: 56-451-02-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraocular Pressure; Corneal Edema

Keywords

Intraocular pressure; Corneal edema; Tonometer; Dynamic contour tonometer; Tonopen; iCare; Goldmann applanation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relationship between the central corneal thickness and intraocular pressure measured by each tonometer

  A day after surgery (clinical corneal edema was detected) and within 1-2 weeks (resolution of edema)

Study Arms (1)

Corneal edema

Intraocular pressure measurement

Other: Intraocular pressure measurement

Interventions

Intraocular pressure measurement OTHER

Using different tonometers for intraocular pressure measurement

Corneal edema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Corneal Edema

Interventions

Intraocular Pressure

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

• Weerawat Kiddee, MD

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 23, 2013
• First Posted: December 2, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)