KeratoconusNCT06739018
Anterior Segment and Corneal Parameters in Keratoconus and High Myopic Astigmatism Using Schiempflug Imaging
An observational study of Keratoconus and High Myopia, run by Assiut University at 2 sites in Egypt.
Trial summary
The purpose of this study was to compare Scheimpflug corneal tomography findings in keratoconus and high myopic astigmatic eyes, as well as to establish the parameters distinguishing keratoconus from high myopic astigmatism. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Keratoconus, High Myopia
- What is being tested?
- pentacam scheimpflug tomography
- How many people
- 66 participants
- Where
- 2 sitesEgypt
- Study dates
- Dec 2024to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The population represents individuals either have keratoconus or high mopic astigmatism and fit the inclusion and exclusion criteria to ensure proper comparison of corneal parameters .
Who may be able to join
- keratoconus patient
- virgin clear cornea with high myopic astigmatism
- normal cornea with high myopic astigmatism
Who cannot join
- patients had previous ocular surgery
- ocular diseases rather than keratoconus
- contact lens wearer
- corneal opacity and corneal dystrophy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Assiut university
Asyut, Asyut Governorate, 71526
Assiut university
Asyut, 71515
About this study
Official title: Comparison of Anterior Segment and Corneal Parameters in Keratoconus and High Myopic Astigmatism Using Schiempflug Imaging
The purpose of this study was to compare Scheimpflug corneal tomography findings in keratoconus and high myopic astigmatic eyes, as well as to establish the parameters distinguishing keratoconus from high myopic astigmatism.
Read the detailed description
Keratoconus is a progressive, non-inflammatory corneal ecstatic disorder caused by alteration in the structure and organization of corneal collagen fibers. It results in uneven steepening of the cornea, resulting in irregular astigmatism that cannot be totally corrected with glasses, impairing the quality of life . However, in many cases, increased axial length adds to the myopic component of refractive error . Thereafter, keratoconus patients frequently have axial high myopia with irregular astigmatism . Furthermore, early diagnosis of keratoconus aids in the timely management of the condition, thus improving patients' quality of life. According to research, high myopia, in addition to the degree of astigmatism, is an alarming sign that requires further corneal assessment to rule out any corneal abnormalities such as keratoconus. Furthermore, keratoconus could be misdiagnosed as meridional amblyopia attributable to myopic astigmatism due to the lack of corneal tomography measurements . As a result, it is critical to evaluate all high myopia patients, particularly those considering refractive surgery, for high-risk corneas.
The criteria for diagnosing and classifying keratoconus are based on anterior corneal curvature data obtained using Placido-based corneal topography . Early alterations in eyes with keratoconus, however, have been found on the posterior corneal surface . Scheimpflug imaging uses a revolving Scheimpflug camera to determine the front and back surfaces of the cornea, hence measuring the overall thickness. Several studies have utilized Scheimpflug tomography to evaluate anterior segment parameters between normal eyes and eyes with keratoconus , but the utility of Scheimpflug imaging to distinguish between keratoconus and high myopic astigmatism has not been thoroughly examined.
- Conditions
- Keratoconus, High Myopia
- Being tested
- pentacam scheimpflug tomography
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentacam scheimpflug tomographyOther
Pentacam tomography is not radiation-based. It uses Scheimpflug imaging, which involves a rotating camera that captures multiple images of the anterior segment of the eye. The system employs light-based technology to measure the front and back surfaces of the cornea, along with the anterior chamber and lens, creating a 3D model of the anterior eye structures.
it uses light instead of ionizing radiation (like X-rays), it is considered safe and non-invasive for routine use in ophthalmology.
- It was used to assess 23 parameters from topographic maps and 15 parameters from Belin-Ambrosio enhanced ectasia (BAD) display maps.
- Parameters included keratometry readings, anterior and posterior sagittal curvature, corneal thickness, anterior chamber volume, and several indices from the BAD display map.
- These parameters were analyzed to discriminate between keratoconus and high myopic astigmatism using Receiver Operating Characteristic (ROC) curves for diagnostic accuracy.
| Study group | Role | What they receive |
|---|---|---|
| keratoconic group | patients with keratoconus Receives: Other: pentacam scheimpflug tomography | |
| high myopic astigmatim group | patients with high myopic astigmatism Receives: Other: pentacam scheimpflug tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall corneal mean difference thickness between keratoconus and mopc astigmatism
Scheimpflug imaging uses a revolving Scheimpflug camera to determine the front and back surfaces of the cornea, hence measuring the overall corneal mean difference thickness between keratoconus and mopc astigmatism as regarding central anterior chamber depth
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youstena Saied Waheb, Assiut University
- Investigators
- Momen Aly, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739018
- Sponsor's protocol ID
- pentacam parameters compare
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zaabaar E, Kyei S, Parkson Brew MAA, Boadi-Kusi SB, Assiamah F, Asiedu K. The utility of measures of anterior segment parameters of a Pentacam Scheimpflug tomographer in discriminating high myopic astigmatism from keratoconus. PLoS One. 2021 Dec 2;16(12):e0260648. doi: 10.1371/journal.pone.0260648. eCollection 2021.
PubMed 34855828
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anterior Segment and Corneal Parameters in Keratoconus and High Myopic Astigmatism Using Schiempflug Imaging
- ClinicalTrials.gov ID
- NCT06739018
- Acronym / sponsor ID
- pentacam parameters compare
- Conditions
- Keratoconus, High Myopia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 18 Dec 2024 (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.
The purpose of this study was to compare Scheimpflug corneal tomography findings in keratoconus and high myopic astigmatic eyes, as well as to establish the parameters distinguishing keratoconus from high myopic astigmatism.
Detailed description
Keratoconus is a progressive, non-inflammatory corneal ecstatic disorder caused by alteration in the structure and organization of corneal collagen fibers. It results in uneven steepening of the cornea, resulting in irregular astigmatism that cannot be totally corrected with glasses, impairing the quality of life . However, in many cases, increased axial length adds to the myopic component of refractive error . Thereafter, keratoconus patients frequently have axial high myopia with irregular astigmatism . Furthermore, early diagnosis of keratoconus aids in the timely management of the condition, thus improving patients' quality of life. According to research, high myopia, in addition to the degree of astigmatism, is an alarming sign that requires further corneal assessment to rule out any corneal abnormalities such as keratoconus. Furthermore, keratoconus could be misdiagnosed as meridional amblyopia attributable to myopic astigmatism due to the lack of corneal tomography measurements . As a result, it is critical to evaluate all high myopia patients, particularly those considering refractive surgery, for high-risk corneas.
The criteria for diagnosing and classifying keratoconus are based on anterior corneal curvature data obtained using Placido-based corneal topography . Early alterations in eyes with keratoconus, however, have been found on the posterior corneal surface . Scheimpflug imaging uses a revolving Scheimpflug camera to determine the front and back surfaces of the cornea, hence measuring the overall thickness. Several studies have utilized Scheimpflug tomography to evaluate anterior segment parameters between normal eyes and eyes with keratoconus , but the utility of Scheimpflug imaging to distinguish between keratoconus and high myopic astigmatism has not been thoroughly examined.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| keratoconic group | – | Other: pentacam scheimpflug tomographypatients with keratoconus |
| high myopic astigmatim group | – | Other: pentacam scheimpflug tomographypatients with high myopic astigmatism |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The population represents individuals either have keratoconus or high mopic astigmatism and fit the inclusion and exclusion criteria to ensure proper comparison of corneal parameters .
Key inclusion criteria (3 listed)
- keratoconus patient
- virgin clear cornea with high myopic astigmatism
- normal cornea with high myopic astigmatism
Key exclusion criteria (4 listed)
- patients had previous ocular surgery
- ocular diseases rather than keratoconus
- contact lens wearer
- corneal opacity and corneal dystrophy
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 |
|---|---|---|
| pentacam scheimpflug tomographyPentacam tomography is not radiation-based. It uses Scheimpflug imaging, which involves a rotating camera that captures multiple images of the anterior segment of the eye. The system employs light-based technology to measure the front and back surfaces of the cornea, along with the anterior chamber and lens, creating a 3D model of the anterior eye structures. it uses light instead of ionizing radiation (like X-rays), it is considered safe and non-invasive for routine use in ophthalmology. * It was used to assess 23 parameters from topographic maps and 15 parameters from Belin-Ambrosio enhanced ectasia (BAD) display maps. * Parameters included keratometry readings, anterior and posterior sagittal curvature, corneal thickness, anterior chamber volume, and several indices from the BAD display map. * These parameters were analyzed to discriminate between keratoconus and high myopic astigmatism using Receiver Operating Characteristic (ROC) curves for diagnostic accuracy. | Other | high myopic astigmatim group, keratoconic group |
Primary outcome
overall corneal mean difference thickness between keratoconus and mopc astigmatism
Time frame: baseline
Scheimpflug imaging uses a revolving Scheimpflug camera to determine the front and back surfaces of the cornea, hence measuring the overall corneal mean difference thickness between keratoconus and mopc astigmatism as regarding central anterior chamber depth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Background: PubMed 34855828Zaabaar E, Kyei S, Parkson Brew MAA, Boadi-Kusi SB, Assiamah F, Asiedu K. The utility of measures of anterior segment parameters of a Pentacam Scheimpflug tomographer in discriminating high myopic astigmatism from keratoconus. PLoS One. 2021 Dec 2;16(12):e0260648. doi: 10.1371/journal.pone.0260648. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Momen Aly, lecturer study director
Assiut University
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 Keratoconus and High Myopia, run by Assiut University at 2 sites in Egypt.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Dec 2024. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact youstena w saied, resident (02+01229887036, youstenasaied@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall corneal mean difference thickness between keratoconus and mopc astigmatism (time frame: baseline). 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 NCT06739018, which also lists 1 linked publication.
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 18 Dec 2024.