Comparison of DCT, ORA and GAT in Eyes After Penetrating Keratoplasty

September 13, 2009 updated by: Sheba Medical Center

Comparison of Pascal Dynamic Contour Tonometer, Reichart Ocular Response Analyzer and Goldmann Applanation Tonometer in Eyes After Penetrating Keratoplasty

To compare intraocular pressure (IOP) measured by the Reichert Ocular Response Analyzer (ORA), Pascal dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT) in eyes after Penetrating Keratoplasty (KPL)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A few tonometers are used today in clinical practice for measuring intra ocular pressure (IOP). Each tonometer is based on different technology.

Post penetrating keratoplasty (PK) eyes are at risk for developing secondary glaucoma (9-14%). Elevation of the IOP may cause rejection of the graft or alternately a loss in the endothelial cell layer count causing decompensation of the cornea. Therefore, measuring accurately the IOP in this population is of great importance.

Measuring IOP in post PK is not an easy challenge, mainly because of parameters like the central corneal thickness (CCT), the curvature of the cornea, the axial length and biomechanical properties which diverse from normal eyes.

The Goldmann applanation tonometer (GAT) is the gold standard tonometer for measuring IOP and is the most popular tonometer clinically used. IOP measurements via the GAT are based on the assumption that the CCT is constant. post PK eyes CCT might diverse from normal eyes causing GAT IOP measurements to be inaccurate. The Pascal dynamic contour tonometer (DCT) measures IOP independently of corneal parameters. The Ocular response analyzer (ORA) is based on a non contact technique of measurement. The tonometer is thought to be independent of factors such as CCT.

The aim of the study is to compare intraocular pressure (IOP) measured by the Reichert Ocular Response Analyzer (ORA), Pascal dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT) in eyes after Penetrating Keratoplasty (KPL). In addition its aim is to discover the dependence of different parameters, like - CCT, curvature of the cornea, axial length and biomechanical properties on IOP measurement to elucidate the appropriate tonometer for this population.

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Not yet recruiting
        • Goldschleger Eye Institute, Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Ido D Fabian, Dr
        • Sub-Investigator:
          • Mordechai Gldenfeld, Dr
        • Sub-Investigator:
          • Alon Skaat, Dr
        • Sub-Investigator:
          • Ehud Rechtman, Dr
        • Sub-Investigator:
          • Irena Barequet, Dr
        • Sub-Investigator:
          • Shlomo Melamed, Prof
      • Ramat Gan, Israel
        • Recruiting
        • The Goldschleger eye institute, Sheba Medical Center, Tel Aviv University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients post keratoplasty surgery

Description

Inclusion Criteria:

  • Eyes after KPL surgery at the Goldschleger Eye Institute in the last 10 years.

Exclusion Criteria:

  • Uncooperative subjects for whom good quality results are unattainable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IOP
Measuring IOP
Procedure: IOP measurement
Measuring IOP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intra ocular pressure
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Corneal compensated intra ocular pressure, Corneal hysteresis, Corneal resistance factor
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Study Chair: Shlomo Melamed, Prof, Sheba medical center, head of Sam rotberg glaucoma center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

February 2, 2009

First Submitted That Met QC Criteria

February 2, 2009

First Posted (Estimate)

February 3, 2009

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 13, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHEBA-09-6902-IDF-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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