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

Corneal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00834782
• Other study ID #: SHEBA-09-6902-IDF-CTIL
• Status: Unknown status
• Phase: Phase 4
• First received: February 2, 2009
• Last updated: September 13, 2009
• Start date: May 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2009
• Source: Sheba Medical Center
• Contact: Ido Didi Fabian, Dr
• Phone: +9727830444
• Email: didifabian[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 35
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Transplantation

Intervention

Procedure:
• IOP measurement
Measuring IOP

Locations

Country	Name	City	State
Israel	Goldschleger eye institute, Sheba medical center	Ramat Gan
Israel	The Goldschleger eye institute, Sheba Medical Center, Tel Aviv University	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (9)

Congdon NG, Broman AT, Bandeen-Roche K, Grover D, Quigley HA. Central corneal thickness and corneal hysteresis associated with glaucoma damage. Am J Ophthalmol. 2006 May;141(5):868-75. Epub 2006 Mar 9. — View Citation

Jain AK, Saini JS, Gupta R. Tonometry in normal and scarred corneas, and in postkeratoplasty eyes: a comparative study of the Goldmann, the ProTon and the Schiotz tonometers. Indian J Ophthalmol. 2000 Mar;48(1):25-32. — View Citation

Kerautret J, Colin J, Touboul D, Roberts C. Biomechanical characteristics of the ectatic cornea. J Cataract Refract Surg. 2008 Mar;34(3):510-3. doi: 10.1016/j.jcrs.2007.11.018. — View Citation

Luce DA. Determining in vivo biomechanical properties of the cornea with an ocular response analyzer. J Cataract Refract Surg. 2005 Jan;31(1):156-62. — View Citation

Medeiros FA, Weinreb RN. Evaluation of the influence of corneal biomechanical properties on intraocular pressure measurements using the ocular response analyzer. J Glaucoma. 2006 Oct;15(5):364-70. — View Citation

Mollan SP, Wolffsohn JS, Nessim M, Laiquzzaman M, Sivakumar S, Hartley S, Shah S. Accuracy of Goldmann, ocular response analyser, Pascal and TonoPen XL tonometry in keratoconic and normal eyes. Br J Ophthalmol. 2008 Dec;92(12):1661-5. doi: 10.1136/bjo.2007.136473. Epub 2008 Aug 29. — View Citation

Pandav SS, Sharma A, Gupta A, Sharma SK, Gupta A, Patnaik B. Reliability of proton and goldmann applanation tonometers in normal and postkeratoplasty eyes. Ophthalmology. 2002 May;109(5):979-84. — View Citation

Rao VJ, Gnanaraj L, Mitchell KW, Figueiredo FC. Clinical comparison of ocular blood flow tonometer, Tonopen, and Goldmann applanation tonometer for measuring intraocular pressure in postkeratoplasty eyes. Cornea. 2001 Nov;20(8):834-8. — View Citation

Touboul D, Roberts C, Kérautret J, Garra C, Maurice-Tison S, Saubusse E, Colin J. Correlations between corneal hysteresis, intraocular pressure, and corneal central pachymetry. J Cataract Refract Surg. 2008 Apr;34(4):616-22. doi: 10.1016/j.jcrs.2007.11.051. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra ocular pressure		1 year
Secondary	Corneal compensated intra ocular pressure, Corneal hysteresis, Corneal resistance factor		1 year