The Intraocular Pressure Measured by Different Tonometers... | NCT01998568

Studies
The Intraocular Pressure Measured by Different Tonometers in Corneal Edema

NCT01998568

Sponsor

Prince of Songkla University

Status

Completed

Last Update Posted

Nov 6, 2017Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Intraocular Pressure
Corneal Edema

Interventions

Intraocular pressure measurement

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Nov 23, 2013

First Submission Date that Met QC Criteria

Nov 29, 2013

First Posted Date

Dec 2, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2017

Last Update Posted Date

Nov 6, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Corneal edema		Intraocular pressure measurement	Other: Intraocular pressure measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraocular pressure measurement	Other	Using different tonometers for intraocular pressure measurement	Corneal edema

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Weerawat Kiddee, MD	Prince of Songkla University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases