CorneaNCT06220578
Analysis of Topographic Corneal Parameters
An observational study of Cornea, run by Minia University at 1 site in Egypt.
Trial summary
The Pentacam HR system (OCULUS) has been suggested to be one of the most sensitive instruments for corneal examination before corneal refractive surgery Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cornea
- What is being tested?
- Oculus pentacam HR
- Type of treatment
- Medical device
- How many people
- 2,694 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 31 Dec 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 45 years
- All sexes
- Adult
Study population: patients examined in Roaa LASIK center from both sexes between 18-45 years seeking corneal refractive surgery
Who may be able to join
- Persons from both sexes between 18 and 45 years seeking corneal refractive surgery
Who cannot join
- Previous intraocular surgery
- Previous corneal surgery
- Corneal opacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Topographic Corneal Parameters in a Large Cohort of Corneal Refractive Surgery Candidates
The Pentacam HR system (OCULUS) has been suggested to be one of the most sensitive instruments for corneal examination before corneal refractive surgery
Read the detailed description
Retrospective non randomized study Analysis of different corneal paremeters obtained by Pentacam for corneal refractive surgery candidates during last 3 years from both sexes between 18 and 45 years K1 - K2 - K max - Pachymetry apex - Pachymetry thinnest - Distance between apex and thinnest - Back elevation - Topography shape - Keratoconus (If present)
- Conditions
- Cornea
- Being tested
- Oculus pentacam HR
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus pentacam HRDevice
Examination of corneal parameters by pentacam
| Study group | Role | What they receive |
|---|---|---|
| candidates seeking corneal refractive surgery | Persons from both sexes between 18 and 45 years seeking corneal refractive surgery Receives: Device: Oculus pentacam HR |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal curvature
radii of curvature in diopters
Measured: 7 months
corneal pachymetry
measured in microns
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2023
- Primary completion30 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies of the same condition, open and under way.
- More trials run by Minia 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,694 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahemd Abdelghany, Minia University
- Investigators
- Ahmed Abdelghany, professor, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220578
- Sponsor's protocol ID
- 592/2023
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not plan to share
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Topographic Corneal Parameters in a Large Cohort of Corneal Refractive Surgery Candidates
- ClinicalTrials.gov ID
- NCT06220578
- Acronym / sponsor ID
- 592/2023
- Conditions
- Cornea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,694 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Jan 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 Pentacam HR system (OCULUS) has been suggested to be one of the most sensitive instruments for corneal examination before corneal refractive surgery
Detailed description
Retrospective non randomized study Analysis of different corneal paremeters obtained by Pentacam for corneal refractive surgery candidates during last 3 years from both sexes between 18 and 45 years K1 - K2 - K max - Pachymetry apex - Pachymetry thinnest - Distance between apex and thinnest - Back elevation - Topography shape - Keratoconus (If present)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| candidates seeking corneal refractive surgery | – | Device: Oculus pentacam HRPersons from both sexes between 18 and 45 years seeking corneal refractive surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- patients examined in Roaa LASIK center from both sexes between 18-45 years seeking corneal refractive surgery
Key inclusion criteria (1 listed)
- Persons from both sexes between 18 and 45 years seeking corneal refractive surgery
Key exclusion criteria (3 listed)
- Previous intraocular surgery
- Previous corneal surgery
- Corneal opacity
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 |
|---|---|---|
| Oculus pentacam HRExamination of corneal parameters by pentacam | Device | candidates seeking corneal refractive surgery |
Primary outcome
corneal curvature
Time frame: 7 months
radii of curvature in diopters
corneal pachymetry
Time frame: 7 months
measured in microns
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 24 Jan 2024.
- Individual participant dataSharing planned: No. not plan to share
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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.
Ahmed Abdelghany, professor principal investigator
Minia University
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 Cornea, run by Minia University at 1 site 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 1 inclusion and 3 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 24 Jan 2024. 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 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?
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?
corneal curvature (time frame: 7 months). The study lists 2 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 24 Jan 2024.