The Intraocular Pressure Measured by Different Tonometers in Corneal Edema

Sponsor
Prince of Songkla University (Other)
Overall Status
Completed
CT.gov ID
NCT01998568
Collaborator
(none)
50
1
31
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
The Variation of the Intraocular Pressure Measured by Different Tonometers in Patients With Clinical Corneal Edema
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Corneal edema

Intraocular pressure measurement

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

Outcome Measures

Primary Outcome Measures

  1. Intraocular pressure [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 Outcome Measures

  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)]

    The severity of corneal edema may affect the reliability of intraocular pressure measurement measured by different tonometers

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, Prince of Songkla University Hat Yai Songkhla Thailand 90110

Sponsors and Collaborators

  • Prince of Songkla University

Investigators

  • Principal Investigator: Weerawat Kiddee, MD, Prince of Songkla University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weerawat Kiddee, Doctor, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01998568
Other Study ID Numbers:
  • 56-451-02-1
First Posted:
Dec 2, 2013
Last Update Posted:
Nov 6, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Weerawat Kiddee, Doctor, Prince of Songkla University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 6, 2017