KeratoconusNCT03288116
Objective and Subjective Diagnostic Parameters in the Fellow Eye of Unilateral Keratoconus
An observational study of Keratoconus, run by Dar Al Shifa Hospital.
Trial summary
patients with keratoconus in one eye and forme fruste keratoconus in the fellow eye compared to normal subjects .the patients were examined by schemipflug imaging system (Pentacam) Read more about this study
- Who is it for?
- Ages 14 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Scheimplug imaging and contrast and sensitivity test
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2014to 5 Feb 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 14 to 44 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: unilateral keratoconus
Who may be able to join
- patients with clinically evident keratoconus in one eye and apparently normal in the fellow eye
Who cannot join
- previous ocular surgery or truama,significant corneal scarring or associatedocular pathology
About this study
Official title: Literature in Mansoura Ophthalmic Center ,Mansoura University
patients with keratoconus in one eye and forme fruste keratoconus in the fellow eye compared to normal subjects .the patients were examined by schemipflug imaging system (Pentacam)
Read the detailed description
This cross-sectional study was carried out on patients presenting keratoconus in one eye and forme fruste keratoconus in the fellow eye; the patients attended the outpatient clinic of Mansoura ophthalmic center between January 2014 and February 2015. This study was approved by the institutional research board of the Mansoura faculty of medicine and was performed in accordance with the ethical standards of the Declaration of Helsinki. All patients included in the study provided informed consent.
Ocular examinations were performed on all eyes included in the study. Clinical Keratoconus was diagnosed if all the following criteria were found:1)asymmetric bow tie with skewed radial axis (SRAX), inferior or central steepening on the topography map, 2)mean keratometry (K)>47diopters or an inferior-superior (I-S) value >1.4diopters according to the Rabinowitz and McDonnell criteria[8],and 3)at least one clinical symptom(i.e., stromal thinning, conical protrusion of corneal apex,Fleischer ring, Vogt striae or anterior stromal scar). Forme fruste keratoconus was diagnosed if all the following criteria were found: 1) normal topography, 2) mean K<47D and I-S ≤1.4,3) normal slit lamp, and 4)keratoconus in the fellow eye.
The eyes with an evident keratoconus diagnosis were included in (Group A)and the fellow eyes were included in (Group B).Control cases(Group C) were selected from the normal database of candidates for refractive surgery with the following:1)normal topography, 2)negative rotating Scheimpflug device indices and negative topographic keratoconus classification, 3)normal slit lamp examination, and 4)no history of eye disease(only one eye of each normal candidate was included in the study depending on a computer-based randomizing program).
The exclusion criteria included previous ocular surgery or trauma, significant corneal scarring or associated ocular pathology.
All eyes were examined by rotating Scheimpflug corneal tomography (Pentacam, Oculus Optikgerate GmbH).No patients in the study wore contact lenses. During the Scheimpflug corneal tomography examination, the patient was properly positioned on the chin rest and forehead strap. The patient was asked to blink several times then open both eyes and stare at a fixed target. After obtaining proper alignment, the automatic release mode started the scan; a total of25 single Scheimpflug images were captured within 2 sec for each eye. Three consecutive scans were taken of each eye by the same examiner. The average of the results of three acceptable measurements was included in the study. Each eye was required to have a corneal map with at least 9 mm of corneal coverage and no extrapolated data.
The Pentacam maps were analyzed. The following anterior and posterior corneal surface parameters were evaluated by the Scheimpflug system: corneal dioptric power at the flattest meridian in the 3 mm-central zone(K1),corneal dioptric power in the steepest meridian in the 3mm-central zone (K2)and mean corneal power in the 3mm-zone (mean K).
The pachymetric map was analyzed, including the central corneal thickness (CCT) at the apex of the geometric center and corneal thickness at the thinnest point (CTmin).The average progression index (PPI avg) was calculated as the progression value at the different rings referenced to the mean curve. The minimum (PPI min) and maximum (PPI max) progression indices were recorded. The Ambrósior elational thickness (ART)was calculated as follows: ARTavg=CTmin/PPIavg,ARTmin = CTmin/PPImin, ARTmax =CTmin/PPImax[9].
The posterior corneal elevation maps were evaluated; a reference best fit sphere was calculated at a fixed optical zone of 8 mm, and the posterior corneal elevation values relative to this reference were recorded. The back difference elevation and multimetric D index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia display of the Pentacam system.
Contrast and Glare sensitivity test:
The contract and glare tests were carried out with a Mesotest II (Oculus Optikgeräte GmbH, Wetzlar, Germany), which consists of Landolt rings of different contrast levels presented in front of a low-brightness background. There are 4 contrast levels, 1:23, 1:5, 1:2.7, and 1:2, which represent the ratio between the light intensity of the optotypes and the background. There were 8 tests, 4 without glare and 4 with glare. Test 1, with a contrast level of 1:23, is the most easily recognized. For statistical purposes, each level of the contrast or glare test was given a score ranging from 20% at the 1:23 level to 100% at the 1:2 level.
- Conditions
- Keratoconus
- Being tested
- Scheimplug imaging and contrast and sensitivity test
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheimplug imaging and contrast and sensitivity testDiagnostic test
examination of the patients using the schemiplug imaging with evaluation of keratometric parametres ,pachymetric parametres ,elevation parameters.
| Study group | Role | What they receive |
|---|---|---|
| patient | Scheimplug imaging and contrast and sensitivity test Receives: Diagnostic Test: Scheimplug imaging and contrast and sensitivity test | |
| early disease | Scheimplug imaging and contrast and sensitivity test Receives: Diagnostic Test: Scheimplug imaging and contrast and sensitivity test | |
| normal | Scheimplug imaging and contrast and sensitivity test Receives: Diagnostic Test: Scheimplug imaging and contrast and sensitivity test |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratometric power of the corneal surface
in diopter
Measured: 1 year
corneal thickness(pachymetry)
in micrometer
Measured: 1 year
corneal elevations
in micrometer
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 posted19 Sep 2017
- Study start2 Jan 2014
- Primary completion5 Feb 2015
- Study completion5 Feb 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dar Al Shifa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, magda torky, Dar Al Shifa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288116
- Sponsor's protocol ID
- 2352
- Status last verified
- Sep 2017
- First submitted
- 30 Aug 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Literature in Mansoura Ophthalmic Center ,Mansoura University
- ClinicalTrials.gov ID
- NCT03288116
- Acronym / sponsor ID
- 2352
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dar Al Shifa HospitalUniversity, hospital or other
- Study start
- 2 Jan 2014 (actual)
- Primary completion
- 5 Feb 2015 (actual)
- Study completion
- 5 Feb 2015 (actual)
- First posted
- 19 Sep 2017 (actual)
- 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.
patients with keratoconus in one eye and forme fruste keratoconus in the fellow eye compared to normal subjects .the patients were examined by schemipflug imaging system (Pentacam)
Detailed description
This cross-sectional study was carried out on patients presenting keratoconus in one eye and forme fruste keratoconus in the fellow eye; the patients attended the outpatient clinic of Mansoura ophthalmic center between January 2014 and February 2015. This study was approved by the institutional research board of the Mansoura faculty of medicine and was performed in accordance with the ethical standards of the Declaration of Helsinki. All patients included in the study provided informed consent.
Ocular examinations were performed on all eyes included in the study. Clinical Keratoconus was diagnosed if all the following criteria were found:1)asymmetric bow tie with skewed radial axis (SRAX), inferior or central steepening on the topography map, 2)mean keratometry (K)>47diopters or an inferior-superior (I-S) value >1.4diopters according to the Rabinowitz and McDonnell criteria[8],and 3)at least one clinical symptom(i.e., stromal thinning, conical protrusion of corneal apex,Fleischer ring, Vogt striae or anterior stromal scar). Forme fruste keratoconus was diagnosed if all the following criteria were found: 1) normal topography, 2) mean K<47D and I-S ≤1.4,3) normal slit lamp, and 4)keratoconus in the fellow eye.
The eyes with an evident keratoconus diagnosis were included in (Group A)and the fellow eyes were included in (Group B).Control cases(Group C) were selected from the normal database of candidates for refractive surgery with the following:1)normal topography, 2)negative rotating Scheimpflug device indices and negative topographic keratoconus classification, 3)normal slit lamp examination, and 4)no history of eye disease(only one eye of each normal candidate was included in the study depending on a computer-based randomizing program).
The exclusion criteria included previous ocular surgery or trauma, significant corneal scarring or associated ocular pathology.
All eyes were examined by rotating Scheimpflug corneal tomography (Pentacam, Oculus Optikgerate GmbH).No patients in the study wore contact lenses. During the Scheimpflug corneal tomography examination, the patient was properly positioned on the chin rest and forehead strap. The patient was asked to blink several times then open both eyes and stare at a fixed target. After obtaining proper alignment, the automatic release mode started the scan; a total of25 single Scheimpflug images were captured within 2 sec for each eye. Three consecutive scans were taken of each eye by the same examiner. The average of the results of three acceptable measurements was included in the study. Each eye was required to have a corneal map with at least 9 mm of corneal coverage and no extrapolated data.
The Pentacam maps were analyzed. The following anterior and posterior corneal surface parameters were evaluated by the Scheimpflug system: corneal dioptric power at the flattest meridian in the 3 mm-central zone(K1),corneal dioptric power in the steepest meridian in the 3mm-central zone (K2)and mean corneal power in the 3mm-zone (mean K).
The pachymetric map was analyzed, including the central corneal thickness (CCT) at the apex of the geometric center and corneal thickness at the thinnest point (CTmin).The average progression index (PPI avg) was calculated as the progression value at the different rings referenced to the mean curve. The minimum (PPI min) and maximum (PPI max) progression indices were recorded. The Ambrósior elational thickness (ART)was calculated as follows: ARTavg=CTmin/PPIavg,ARTmin = CTmin/PPImin, ARTmax =CTmin/PPImax[9].
The posterior corneal elevation maps were evaluated; a reference best fit sphere was calculated at a fixed optical zone of 8 mm, and the posterior corneal elevation values relative to this reference were recorded. The back difference elevation and multimetric D index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia display of the Pentacam system.
Contrast and Glare sensitivity test:
The contract and glare tests were carried out with a Mesotest II (Oculus Optikgeräte GmbH, Wetzlar, Germany), which consists of Landolt rings of different contrast levels presented in front of a low-brightness background. There are 4 contrast levels, 1:23, 1:5, 1:2.7, and 1:2, which represent the ratio between the light intensity of the optotypes and the background. There were 8 tests, 4 without glare and 4 with glare. Test 1, with a contrast level of 1:23, is the most easily recognized. For statistical purposes, each level of the contrast or glare test was given a score ranging from 20% at the 1:23 level to 100% at the 1:2 level.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient | – | Diagnostic Test: Scheimplug imaging and contrast and sensitivity testScheimplug imaging and contrast and sensitivity test |
| early disease | – | Diagnostic Test: Scheimplug imaging and contrast and sensitivity testScheimplug imaging and contrast and sensitivity test |
| normal | – | Diagnostic Test: Scheimplug imaging and contrast and sensitivity testScheimplug imaging and contrast and sensitivity test |
Who may qualify
- Ages
- 14 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- unilateral keratoconus
Key inclusion criteria (1 listed)
- patients with clinically evident keratoconus in one eye and apparently normal in the fellow eye
Key exclusion criteria (1 listed)
- previous ocular surgery or truama,significant corneal scarring or associatedocular pathology
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 |
|---|---|---|
| Scheimplug imaging and contrast and sensitivity testexamination of the patients using the schemiplug imaging with evaluation of keratometric parametres ,pachymetric parametres ,elevation parameters. | Diagnostic test | early disease, normal, patient |
Primary outcome
keratometric power of the corneal surface
Time frame: 1 year
in diopter
corneal thickness(pachymetry)
Time frame: 1 year
in micrometer
corneal elevations
Time frame: 1 year
in micrometer
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 19 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Dar Al Shifa Hospital.
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: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
keratometric power of the corneal surface (time frame: 1 year). The study lists 3 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 19 Sep 2017.