KeratoconusFFTKCNCT02617368
Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus
An observational study of Keratoconus, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of this study was evaluate the diagnostic capacity of fourier analysis of keratometric data in differentiating moderate KC and FFK from healthy corneas. Study participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Keratoconus
- How many people
- 185 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2014to Nov 2015
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants were recruited from the Outpatients Cornea service, in a consecutive if eligible basis
Who may be able to join
- diagnosis of keratoconus KC in the fellow eye according to the Amsler-Krumleich criteria (FFKG)
- KISA index between 60 and 100% in the FFK eye (FFKG)
- lack of any KC-related findings / signs in the slit-lamp biomicroscopy (FFKG)
- uneventful ophthalmologic history (CG)
- no indications of corneal pathology in slit-lamp biomicroscopy and Placido *disk-based videokeratography (CG)
- KISA index value less than 60% (CG)
- diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system (KCG)
Who cannot join
- for all study groups:
- previous incisional eye surgery
- corneal scars and opacities
- history of herpetic keratitis, severe eye dryness
- pregnancy or nursing
- current corneal infection
Show all 10Show fewer
- glaucoma
- suspicion for glaucoma
- IOP lowering treatment
- underlying autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Primary objective of this study was evaluate the diagnostic capacity of fourier analysis of keratometric data in differentiating moderate KC and FFK from healthy corneas.
Study participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Two study groups were formed: a)KC group included patients those were diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system, b) FFK group (FFKG) that included patients diagnosed with FFK, and c) Control group (CG) was formed by refractive surgery candidates. Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced operator in a consistent way.
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Corneal crosslinking, Fourier Analysis of Topographic Data
- 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 |
|---|---|---|
| KC group | KC group included patients those were diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system | |
| Forme Fruste Keratoconus Group (FFKG) | Forme Fruste Keratoconus Group (FFKG) included patients diagnosed with FFK. | |
| Control Group (CG) | Control group(CG) was formed by refractive surgery candidates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical Component (SphRmin)
Spherical Component (SphRmin) displays the arithmetic mean of all radii of curvature for each ring
Measured: One Day
Spherical Eccentricity (SphEcc)
Spherical Eccentricity is the asphericity that is calculated
Measured: One Day
Maximum Decentration (MaxDec)
decentration or asymmetry of the astigmatic component which is derived from first order component of fourier analysis
Measured: One Day
Regular Astigmatism at the Center(AstC)
the regular astigmatic component is calculated in the center and it is derived from the second order component of Fourier Analysis
Measured: One Day
Regular Astigmatism at the Periphery (AstP)
the regular astigmatic component is calculated in the periphery and it is derived from the second order component of Fourier Analysis
Measured: One day
Mean Astigmatism (MAst)
Mean Astigmatism is the average of astigmatism at the center and the periphery (MAst)
Measured: One Day
Irregularitiy (Irr)
Measured: one Day
Astigmatism at the Center plus the Irregularities (AstCir)
the irregularities of the cornea which can not be corrected by sphere, cylinder or prism and it is derived from higher order components of Fourier Analysis of Keratometric Data
Measured: One day
Total Astigmatism (Tast) which is the sum of Mean Astigmatism and Irregularities.
Total Astigmatism (Tast) is the sum of Mean Astigmatism and Irregularities.
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionNov 2015
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
- Enrolment
- 185 participants (actual)
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
- NCT02617368
- Sponsor's protocol ID
- 304/23/11/2015
- Acronym
- FFTKC
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2015
- Last updated
- 1 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fourier Transform of Videokeratography Data: Clinical Usefulness in Moderate and Frome Fruste Keratoconus
- ClinicalTrials.gov ID
- NCT02617368
- Acronym / sponsor ID
- FFTKC / 304/23/11/2015
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Corneal crosslinking, Fourier Analysis of Topographic Data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Dec 2015 (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.
Primary objective of this study was evaluate the diagnostic capacity of fourier analysis of keratometric data in differentiating moderate KC and FFK from healthy corneas.
Study participants were recruited from the Cornea Outpatient service in a consecutive if eligible basis. Two study groups were formed: a)KC group included patients those were diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system, b) FFK group (FFKG) that included patients diagnosed with FFK, and c) Control group (CG) was formed by refractive surgery candidates. Pentacam (Pentacam HR, Oculus Optikgerate GmbH, Heidelberg, Germany)measurements were performed by the same experienced operator in a consistent way.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KC group | – | –KC group included patients those were diagnosed and classified for moderate keratoconus according to the Amsler-Krumeich classification system |
| Forme Fruste Keratoconus Group (FFKG) | – | –Forme Fruste Keratoconus Group (FFKG) included patients diagnosed with FFK. |
| Control Group (CG) | – | –Control group(CG) was formed by refractive surgery candidates. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants were recruited from the Outpatients Cornea service, in a consecutive if eligible basis
Key inclusion criteria (7 listed)
- diagnosis of keratoconus KC in the fellow eye according to the Amsler-Krumleich criteria (FFKG)
- KISA index between 60 and 100% in the FFK eye (FFKG)
- lack of any KC-related findings / signs in the slit-lamp biomicroscopy (FFKG)
- uneventful ophthalmologic history (CG)
- no indications of corneal pathology in slit-lamp biomicroscopy and Placido *disk-based videokeratography (CG)
Key exclusion criteria (10 listed)
- for all study groups:
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
Spherical Component (SphRmin)
Time frame: One Day
Spherical Component (SphRmin) displays the arithmetic mean of all radii of curvature for each ring
Spherical Eccentricity (SphEcc)
Time frame: One Day
Spherical Eccentricity is the asphericity that is calculated
Maximum Decentration (MaxDec)
Time frame: One Day
decentration or asymmetry of the astigmatic component which is derived from first order component of fourier analysis
Regular Astigmatism at the Center(AstC)
Time frame: One Day
the regular astigmatic component is calculated in the center and it is derived from the second order component of Fourier Analysis
Regular Astigmatism at the Periphery (AstP)
Time frame: One day
the regular astigmatic component is calculated in the periphery and it is derived from the second order component of Fourier Analysis
Mean Astigmatism (MAst)
Time frame: One Day
Mean Astigmatism is the average of astigmatism at the center and the periphery (MAst)
Irregularitiy (Irr)
Time frame: one Day
Astigmatism at the Center plus the Irregularities (AstCir)
Time frame: One day
the irregularities of the cornea which can not be corrected by sphere, cylinder or prism and it is derived from higher order components of Fourier Analysis of Keratometric Data
Total Astigmatism (Tast) which is the sum of Mean Astigmatism and Irregularities.
Time frame: One Day
Total Astigmatism (Tast) is the sum of Mean Astigmatism and Irregularities.
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 1 Dec 2015.
Related trials for Keratoconus
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
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, 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 7 inclusion and 10 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 1 Dec 2015. 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?
Spherical Component (SphRmin) (time frame: One Day). The study lists 9 primary outcomes in all. 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 1 Dec 2015.