KeratoconusNCT01448408
Corneal Biomechanical Properties and Anterior Segment Parameters, in Forme Fruste Keratoconus
An observational study of Keratoconus and Forme Fruste Keratoconus, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
The present study attempts to evaluate the diagnostic capacity of a) anterior segment parameters b) biomechanical metrics and c) a combination model, in differentiating Forme Fruste Keratoconus (FFK) from healthy corneas. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Keratoconus, Forme Fruste Keratoconus
- How many people
- Not given
- Where
- 1 siteGreece
- Study dates
- May 2007to Jul 2011
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: All participants were recruited from the Outpatients Cornea service of the EIT in a consecutive if eligible basis
Who may be able to join
- Diagnosis of Forme Fruste Keratoconus
Who cannot join
- previous incisional eye surgery
- corneal scars and opacities
- a history of herpetic keratitis
- severe eye dryness
- pregnancy or nursing
- current corneal infection
- underlying autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Sensitivity, Specificity, and Test Accuracy of Corneal Biomechanical Metrics, Anterior Segment Data and a Combination Model, in Differentiating Forme Fruste Keratoconus (FFK) From Healthy Corneas.
The present study attempts to evaluate the diagnostic capacity of a) anterior segment parameters b) biomechanical metrics and c) a combination model, in differentiating Forme Fruste Keratoconus (FFK) from healthy corneas.
The study adhered to the tenets of the Declaration of Helsinki and written informed consent was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ), in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing primarily on the conditions of the anterior segment of the eye.
Read more
All participants underwent a complete clinical evaluation including review of medical history, visual acuity measurements, uncorrected and best corrected visual acuity, placido disc topography, Scheimpflug camera measurements, ORA measurements , slitlamp biomicroscopy and fundoscopic examination.
All study participants were divided in two groups. The FFK group (FFKG) consisted of patients with unilateral KC.
The control group (CG) was formed by refractive surgery candidates who visited EIT's outpatients service for their preoperative examination.
CRF and CH parameters were obtained while the patient was sitting on a chair in front of the Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device. Upon successful fixation of the patient's eye on a red blinking target, the operator activated the device. An air puff was released by a non-contact probe, which scanned the central area of the eye and sent a signal to the ORA. In brief, the air puff causes the cornea to move inward, past applanation, and into slight concavity. After milliseconds, the air pumps shut off, the pressure decreases, and the cornea begins to return in its normal state. The system monitors the entire process and measures two pressure values, which are determined from the inward and outward applanation processes. The aforementioned measuring procedure enables the determination of CH which is related to the viscoelastic structure of the corneal tissue, and is calculated as the difference between the two pressure values at the two applanation processes, and CRF which is indicative of the overall resistance of the cornea and is calculated as a linear function of the two pressures associated with the two applanation. In order to ensure accurate results, ORA was done four times for each eye, by the same operator. Signals that differ significantly in appearance from the other signals from the same eye were deleted.
Corneal Astigmatism (Cyl), Anterior Chamber Depth (ACD), Corneal Volume at 3mm (CV3), at 5mm (CV5), and overall (CV), Central Corneal Thickness (CCT), Thinnest Corneal Thickness (TCT) and TCT co-ordinates (TCTx, TCTy) were obtained using Pentacam. KISA index was calculated using Pentacam derived topography. Pentacam is based on a rotating Scheimpflug camera and monochromatic slit light source (a blue light emitted diode at 475 nm) which rotate together. After proper alignment of the patient's head, a fixation target is shown which guides the patients gaze. A real time image of the patient's eye is shown to the examiner on the computer screen, and the image is manually focused and centered. Acceptable maps had at least 10.0mm of corneal coverage. Moreover, images with extrapolated data in the central 9.0mm zone were excluded. Regarding the measuring procedure itself, patients were asked to blink and then look at the fixation device. In case of low-quality image, the procedure was repeated until the acceptable criteria were met.
The data from the FFKG were compared with those from the CG in separate series analyses. Receiver operating characteristics (ROC) curves were applied to determine the overall predictive accuracy of the test for each studied parameter, as described by the area under the curve. We also used this approach to identify the cut-off points for studied parameters to maximize sensitivity and specificity in discriminating FFK cases from normal corneas. Logistic regression was used to support the cut-off point identified in the ROC curve analysis. We determined a cutoff value that will gave us the best predictive fit for our sample data. Furthermore, logistic regression analysis was performed to determine the predictive capability of a model that combined both corneal biomechanical properties and pentacam derived anterior segment parameters.
Differences between groups were evaluated using the Welch modified Student's two sample t-test and Mann-Whitney U test, according to normality of distribution for each parameter. A Kolmogorov-Smirnov test of normality was applied to all variables of each group. The level of significance for each parameter was set at p<0.05. The Pearson and Spearman tests were performed in order to assess correlations between anterior segment parameters and biomechanical properties, depending on their parametric evaluation.
- Conditions
- Keratoconus, Forme Fruste Keratoconus
- Keywords
- Forme Fruste Keratoconus, Corneal Biomechanical properties, Anterior Segment Parameters, Diagnostic Capacity
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Forme Fruste Keratoconus group (FFKG) | FFK eyes had to present a) no apparent signs of KC in clinical examination b) stage 0 in the Amsler-Krumeich scale, and c) demonstrate a KISA index value between 60-100% | |
| Normal Group (CG) | Eligibility for participation in the CG was confirmed by consecutive topographies, while all CG participants had to present uneventful ophthalmologic history, no indications of corneal pathology in slit-lamp biomicroscopy and Placido disk-based videokeratography and KISA index value less than 60%, as well. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, Specificity and Predictive accuracy of CH, CRF, Cyl, ACD,CV, CV3, CV5 CCT, TCT, TCTx, TCTy and of a combination model
The data from the FFKG were compared with those from the CG in separate series analysis. ROC curves were applied to determine the overall predictive accuracy of the test for each parameter. We also used this approach to identify the cut-off points for all parameters in discriminating FFK cases from normal corneas. Logistic regression was used to support the cut-off points identified in the ROC curve analysis. Furthermore, same analysis was performed to determine the predictive capability of a model that combined both corneal biomechanical properties and anterior segment parameters.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startMay 2007
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448408
- Sponsor's protocol ID
- 26/27-09-2011
- Status last verified
- Oct 2011
- First submitted
- 5 Oct 2011
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Sensitivity, Specificity, and Test Accuracy of Corneal Biomechanical Metrics, Anterior Segment Data and a Combination Model, in Differentiating Forme Fruste Keratoconus (FFK) From Healthy Corneas.
- ClinicalTrials.gov ID
- NCT01448408
- Acronym / sponsor ID
- 26/27-09-2011
- Conditions
- Keratoconus, Forme Fruste Keratoconus
- Keywords
- Forme Fruste Keratoconus, Corneal Biomechanical properties, Anterior Segment Parameters, Diagnostic Capacity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- May 2007
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Oct 2011 (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.
The present study attempts to evaluate the diagnostic capacity of a) anterior segment parameters b) biomechanical metrics and c) a combination model, in differentiating Forme Fruste Keratoconus (FFK) from healthy corneas.
The study adhered to the tenets of the Declaration of Helsinki and written informed consent was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ), in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing primarily on the conditions of the anterior segment of the eye.
All participants underwent a complete clinical evaluation including review of medical history, visual acuity measurements, uncorrected and best corrected visual acuity, placido disc topography, Scheimpflug camera measurements, ORA measurements , slitlamp biomicroscopy and fundoscopic examination.
All study participants were divided in two groups. The FFK group (FFKG) consisted of patients with unilateral KC.
The control group (CG) was formed by refractive surgery candidates who visited EIT's outpatients service for their preoperative examination.
CRF and CH parameters were obtained while the patient was sitting on a chair in front of the Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device. Upon successful fixation of the patient's eye on a red blinking target, the operator activated the device. An air puff was released by a non-contact probe, which scanned the central area of the eye and sent a signal to the ORA. In brief, the air puff causes the cornea to move inward, past applanation, and into slight concavity. After milliseconds, the air pumps shut off, the pressure decreases, and the cornea begins to return in its normal state. The system monitors the entire process and measures two pressure values, which are determined from the inward and outward applanation processes. The aforementioned measuring procedure enables the determination of CH which is related to the viscoelastic structure of the corneal tissue, and is calculated as the difference between the two pressure values at the two applanation processes, and CRF which is indicative of the overall resistance of the cornea and is calculated as a linear function of the two pressures associated with the two applanation. In order to ensure accurate results, ORA was done four times for each eye, by the same operator. Signals that differ significantly in appearance from the other signals from the same eye were deleted.
Corneal Astigmatism (Cyl), Anterior Chamber Depth (ACD), Corneal Volume at 3mm (CV3), at 5mm (CV5), and overall (CV), Central Corneal Thickness (CCT), Thinnest Corneal Thickness (TCT) and TCT co-ordinates (TCTx, TCTy) were obtained using Pentacam. KISA index was calculated using Pentacam derived topography. Pentacam is based on a rotating Scheimpflug camera and monochromatic slit light source (a blue light emitted diode at 475 nm) which rotate together. After proper alignment of the patient's head, a fixation target is shown which guides the patients gaze. A real time image of the patient's eye is shown to the examiner on the computer screen, and the image is manually focused and centered. Acceptable maps had at least 10.0mm of corneal coverage. Moreover, images with extrapolated data in the central 9.0mm zone were excluded. Regarding the measuring procedure itself, patients were asked to blink and then look at the fixation device. In case of low-quality image, the procedure was repeated until the acceptable criteria were met.
The data from the FFKG were compared with those from the CG in separate series analyses. Receiver operating characteristics (ROC) curves were applied to determine the overall predictive accuracy of the test for each studied parameter, as described by the area under the curve. We also used this approach to identify the cut-off points for studied parameters to maximize sensitivity and specificity in discriminating FFK cases from normal corneas. Logistic regression was used to support the cut-off point identified in the ROC curve analysis. We determined a cutoff value that will gave us the best predictive fit for our sample data. Furthermore, logistic regression analysis was performed to determine the predictive capability of a model that combined both corneal biomechanical properties and pentacam derived anterior segment parameters.
Differences between groups were evaluated using the Welch modified Student's two sample t-test and Mann-Whitney U test, according to normality of distribution for each parameter. A Kolmogorov-Smirnov test of normality was applied to all variables of each group. The level of significance for each parameter was set at p<0.05. The Pearson and Spearman tests were performed in order to assess correlations between anterior segment parameters and biomechanical properties, depending on their parametric evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forme Fruste Keratoconus group (FFKG) | – | –FFK eyes had to present a) no apparent signs of KC in clinical examination b) stage 0 in the Amsler-Krumeich scale, and c) demonstrate a KISA index value between 60-100% |
| Normal Group (CG) | – | –Eligibility for participation in the CG was confirmed by consecutive topographies, while all CG participants had to present uneventful ophthalmologic history, no indications of corneal pathology in slit-lamp biomicroscopy and Placido disk-based videokeratography and KISA index value less than 60%, as well. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All participants were recruited from the Outpatients Cornea service of the EIT in a consecutive if eligible basis
Key inclusion criteria (1 listed)
- Diagnosis of Forme Fruste Keratoconus
Key exclusion criteria (7 listed)
- previous incisional eye surgery
- corneal scars and opacities
- a history of herpetic keratitis
- severe eye dryness
- pregnancy or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity, Specificity and Predictive accuracy of CH, CRF, Cyl, ACD,CV, CV3, CV5 CCT, TCT, TCTx, TCTy and of a combination model
The data from the FFKG were compared with those from the CG in separate series analysis. ROC curves were applied to determine the overall predictive accuracy of the test for each parameter. We also used this approach to identify the cut-off points for all parameters in discriminating FFK cases from normal corneas. Logistic regression was used to support the cut-off points identified in the ROC curve analysis. Furthermore, same analysis was performed to determine the predictive capability of a model that combined both corneal biomechanical properties and anterior segment parameters.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus and Forme Fruste Keratoconus, run by Democritus University of Thrace at 1 site in Greece.
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 7 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: finished, as of the sponsor's last update on 7 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, Specificity and Predictive accuracy of CH, CRF, Cyl, ACD,CV, CV3, CV5 CCT, TCT, TCTx, TCTy and of a combination model. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2011.