Aberration, Corneal WavefrontNCT05741190
Correlation of Angle Kappa , Corneal High Order Aberrations and Total Eye Aberrations in Various Refractive Errors
An observational study of Aberration, Corneal Wavefront, run by Sohag University.
Trial summary
Identification of the correlation between angle kappa , corneal high order aberrations and total eye aberrations in myopic hyperopic and astigmatic patients Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aberration, Corneal Wavefront
- What is being tested?
- Pentacam Imaging
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Nov 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with no ocular disease other than errors of refraction over 18 years old
Who may be able to join
- Patients with errors of refraction above the age of 18
- No history of trauma.
- No other ocular disease .
Who cannot join
- patient under age of 18
- patients with systemic disease.
- patient with corneal diseases
- Patient who did any sort of occular surgery
- patient refusal
Trial locations and contacts
No sites are listed yet.
Mohammed Anbar, ass.Prof contact
About this study
Identification of the correlation between angle kappa , corneal high order aberrations and total eye aberrations in myopic hyperopic and astigmatic patients
Read the detailed description
The patient will be thoroughly examined clinically on slit lamp detailed history will be obtained visual acuity will be measured and patient refraction will be taken then imaging on Sirius topographer will be used to obtain angle Kappa and high order aberrations of the cornea and I-design pentacam imaging will be used to get the total aberrations of the eye
- Conditions
- Aberration, Corneal Wavefront
- Being tested
- Pentacam Imaging
- Medical subject headings
- Corneal Wavefront Aberration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacam ImagingDevice
Imaging of the corneal surface
| Study group | Role | What they receive |
|---|---|---|
| myope | Patients with myopia Receives: Device: Pentacam Imaging | |
| Hypermetrope | Patients with hypermetropia Receives: Device: Pentacam Imaging | |
| Astigmatic | Patients with Astigmatism Receives: Device: Pentacam Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between angle Kappa and high order aberrations of the cornea and total aberrations of the eye in various refractive errors
does the refraction affect the angle kappa or the corneal high order aberrations or the total aberrations of the eye
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (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 Aberration, Corneal WavefrontStudies of the same condition, open and under way.
- More trials run by Sohag 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Magdy Ezzat, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741190
- Sponsor's protocol ID
- Angle Kappa and aberrations
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gharieb Ibrahim HM, Gharieb HM, Othman IS. Angle kappa Measurement and Its Correlation with Other Ocular Parameters in Normal Population by a New Imaging Modality. Optom Vis Sci. 2022 Jul 1;99(7):580-588. doi: 10.1097/OPX.0000000000001910. Epub 2022 Jun 3.
PubMed 35657347
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Angle Kappa , Corneal High Order Aberrations and Total Eye Aberrations in Various Refractive Errors
- ClinicalTrials.gov ID
- NCT05741190
- Acronym / sponsor ID
- Angle Kappa and aberrations
- Conditions
- Aberration, Corneal Wavefront
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 23 Feb 2023 (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.
Identification of the correlation between angle kappa , corneal high order aberrations and total eye aberrations in myopic hyperopic and astigmatic patients
Detailed description
The patient will be thoroughly examined clinically on slit lamp detailed history will be obtained visual acuity will be measured and patient refraction will be taken then imaging on Sirius topographer will be used to obtain angle Kappa and high order aberrations of the cornea and I-design pentacam imaging will be used to get the total aberrations of the eye
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| myope | – | Device: Pentacam ImagingPatients with myopia |
| Hypermetrope | – | Device: Pentacam ImagingPatients with hypermetropia |
| Astigmatic | – | Device: Pentacam ImagingPatients with Astigmatism |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with no ocular disease other than errors of refraction over 18 years old
Key inclusion criteria (3 listed)
- Patients with errors of refraction above the age of 18
- No history of trauma.
- No other ocular disease .
Key exclusion criteria (5 listed)
- patient under age of 18
- patients with systemic disease.
- patient with corneal diseases
- Patient who did any sort of occular surgery
- patient refusal
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 ImagingImaging of the corneal surface | Device | Astigmatic, Hypermetrope, myope |
Primary outcome
correlation between angle Kappa and high order aberrations of the cornea and total aberrations of the eye in various refractive errors
Time frame: baseline
does the refraction affect the angle kappa or the corneal high order aberrations or the total aberrations of the eye
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 35657347Gharieb Ibrahim HM, Gharieb HM, Othman IS. Angle kappa Measurement and Its Correlation with Other Ocular Parameters in Normal Population by a New Imaging Modality. Optom Vis Sci. 2022 Jul 1;99(7):580-588. doi: 10.1097/OPX.0000000000001910. Epub 2022 Jun 3.
Related trials for Aberration, Corneal Wavefront
Not yet recruiting
Factors Influencing Subjective Visual Quality in Human Eyes
Corneal Wavefront Aberration, Refractive Errors
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.
Mohammed Anbar, ass.Prof contact
Questions about this trial
What is this clinical trial studying?
An observational study of Aberration, Corneal Wavefront, run by Sohag University.
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 5 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 12 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Magdy, Resident (+201111902538, mariomagdy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between angle Kappa and high order aberrations of the cornea and total aberrations of the eye in various refractive errors (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 NCT05741190, 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 12 Apr 2023.