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

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00834782
Collaborator
(none)
35
2
12
17.5
1.5

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: IOP measurement

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 Design

Study Type:
Observational
Anticipated Enrollment :
35 participants
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
Study Start Date :
May 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2009
Anticipated Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
IOP

Measuring IOP

Procedure: IOP measurement
Measuring IOP

Outcome Measures

Primary Outcome Measures

  1. Intra ocular pressure [1 year]

Secondary Outcome Measures

  1. Corneal compensated intra ocular pressure, Corneal hysteresis, Corneal resistance factor [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Goldschleger eye institute, Sheba medical center Ramat Gan Israel
2 The Goldschleger eye institute, Sheba Medical Center, Tel Aviv University Ramat Gan Israel

Sponsors and Collaborators

  • Sheba Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00834782
Other Study ID Numbers:
  • SHEBA-09-6902-IDF-CTIL
First Posted:
Feb 3, 2009
Last Update Posted:
Sep 15, 2009
Last Verified:
Sep 1, 2009
Keywords provided by , ,

Study Results

No Results Posted as of Sep 15, 2009