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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00834782
First received: February 2, 2009
Last updated: September 13, 2009
Last verified: September 2009
  Purpose

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)


Condition Intervention Phase
Corneal Transplantation
Procedure: IOP measurement
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Pascal Dynamic Contour Tonometer, Reichart Ocular Response Analyzer and Goldmann Applanation Tonometer in Eyes After Penetrating Keratoplasty

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Intra ocular pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Corneal compensated intra ocular pressure, Corneal hysteresis, Corneal resistance factor [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IOP
Measuring IOP
Procedure: IOP measurement
Measuring IOP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients post keratoplasty surgery

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834782

Contacts
Contact: Ido Didi Fabian, Dr +9727830444 didifabian@gmail.com

Locations
Israel
Goldschleger eye institute, Sheba medical center Not yet recruiting
Ramat Gan, Israel
Contact: Ido D Fabian, Dr    +9724830444    didifabian@gmail.com   
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         
The Goldschleger eye institute, Sheba Medical Center, Tel Aviv University Recruiting
Ramat Gan, Israel
Contact: Ido Didi Fabian, MD    +9727830444    didifabian@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Chair: Shlomo Melamed, Prof Sheba medical center, head of Sam rotberg glaucoma center
  More Information

Publications:

Responsible Party: Dr Ido Didi Fabian, Sheba Medical Center, Goldschleger eye institute
ClinicalTrials.gov Identifier: NCT00834782     History of Changes
Other Study ID Numbers: SHEBA-09-6902-IDF-CTIL
Study First Received: February 2, 2009
Last Updated: September 13, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
PK
IOP

ClinicalTrials.gov processed this record on July 22, 2014