Corneal TransplantationNCT00834782
Comparison of DCT, ORA and GAT in Eyes After Penetrating Keratoplasty
An observational study of Corneal Transplantation, run by Sheba Medical Center at 2 sites in Israel.
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) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Corneal Transplantation
- What is being tested?
- IOP measurement
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2009to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients post keratoplasty surgery
Who may be able to join
- Eyes after KPL surgery at the Goldschleger Eye Institute in the last 10 years.
Who cannot join
- Uncooperative subjects for whom good quality results are unattainable.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Goldschleger eye institute, Sheba medical center
Ramat Gan
Ido D Fabian, Dr, +9724830444, didifabian@gmail.com
Ido D Fabian, Dr
- Recruiting
The Goldschleger eye institute, Sheba Medical Center, Tel Aviv University
Ramat Gan
Ido Didi Fabian, MD, +9727830444, didifabian@gmail.com
About this study
Official title: 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)
Read the 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.
- Conditions
- Corneal Transplantation
- Being tested
- IOP measurement
- Keywords
- PK, IOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOP measurementProcedure or surgery
Measuring IOP
| Study group | Role | What they receive |
|---|---|---|
| IOP | Measuring IOP Receives: Procedure: IOP measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra ocular pressure
Measured: 1 year
Secondary outcomes (1)
Corneal compensated intra ocular pressure, Corneal hysteresis, Corneal resistance factor
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Corneal TransplantationStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Shlomo Melamed, Prof, Study chair, Sheba medical center, head of Sam rotberg glaucoma center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834782
- Sponsor's protocol ID
- SHEBA-09-6902-IDF-CTIL
- Status last verified
- Sep 2009
- First submitted
- 2 Feb 2009
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1016/j.ajo.2005.12.007. Epub 2006 Mar 9.
PubMed 16527231Jain 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.
PubMed 11271930Kerautret 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.
PubMed 18299080Luce DA. Determining in vivo biomechanical properties of the cornea with an ocular response analyzer. J Cataract Refract Surg. 2005 Jan;31(1):156-62. doi: 10.1016/j.jcrs.2004.10.044.
PubMed 15721708Medeiros 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. doi: 10.1097/01.ijg.0000212268.42606.97.
PubMed 16988597Mollan 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.
PubMed 18757471Pandav 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. doi: 10.1016/s0161-6420(02)00974-0.
PubMed 11986107Rao 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. doi: 10.1097/00003226-200111000-00011.
PubMed 11685061Touboul D, Roberts C, Kerautret 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.
PubMed 18361984
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pascal Dynamic Contour Tonometer, Reichart Ocular Response Analyzer and Goldmann Applanation Tonometer in Eyes After Penetrating Keratoplasty
- ClinicalTrials.gov ID
- NCT00834782
- Acronym / sponsor ID
- SHEBA-09-6902-IDF-CTIL
- Conditions
- Corneal Transplantation
- Keywords
- PK, IOP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOP | – | Procedure: IOP measurementMeasuring IOP |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients post keratoplasty surgery
Key inclusion criteria (1 listed)
- Eyes after KPL surgery at the Goldschleger Eye Institute in the last 10 years.
Key exclusion criteria (1 listed)
- Uncooperative subjects for whom good quality results are unattainable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOP measurementMeasuring IOP | Procedure or surgery | IOP |
Primary outcome
Intra ocular pressure
Time frame: 1 year
1 secondary outcome
Corneal compensated intra ocular pressure, Corneal hysteresis, Corneal resistance factor
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
- Background: PubMed 16527231Congdon 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. doi: 10.1016/j.ajo.2005.12.007. Epub 2006 Mar 9.
- Background: PubMed 11271930Jain 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.
- Background: PubMed 18299080Kerautret 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.
- Background: PubMed 15721708Luce DA. Determining in vivo biomechanical properties of the cornea with an ocular response analyzer. J Cataract Refract Surg. 2005 Jan;31(1):156-62. doi: 10.1016/j.jcrs.2004.10.044.
- Background: PubMed 16988597Medeiros 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. doi: 10.1097/01.ijg.0000212268.42606.97.
- Background: PubMed 18757471Mollan 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.
- Background: PubMed 11986107Pandav 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. doi: 10.1016/s0161-6420(02)00974-0.
- Background: PubMed 11685061Rao 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. doi: 10.1097/00003226-200111000-00011.
- Background: PubMed 18361984Touboul D, Roberts C, Kerautret 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.
Related trials for Corneal Transplantation
Not yet recruiting
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
Cornea Disease
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
RecruitingObservational study
Factors Influencing Corneal Donation in Palliative Care Unit
Corneal Transplantation, Corneal Diseases
Not yet recruiting
Utilization of Residual Donor Tissue for Regrafting in Bullous Keratopathy After Corneal Transplantation
Bullous Keratopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomo Melamed, Prof study chair
Sheba medical center, head of Sam rotberg glaucoma center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Transplantation, run by Sheba Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ido Didi Fabian, Dr (+9727830444, didifabian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra ocular pressure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00834782, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.