Refractive ErrorsNCT06166212
Changes in Angle Kappa and Corneal Back Elevations After Laser in Situ Keratomileusis in Myopic Astigmatism
An observational study of Refractive Errors, run by Ain Shams University.
Trial summary
Refractive errors and corneal astigmatism are associated with changes in angle kappa and corneal back elevation at the thinnest point in Pentacam. The purpose of this study is to track: The effect of anterior corneal astigmatism treatment on angle kappa and corneal back elevation. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Refractive Errors
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Nov 2025
- 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 40 years
- All sexes
- Adult
Study population: 2 groups
Who may be able to join
- Myopic astigmatism
Who cannot join
- Corneal scar
Trial locations and contacts
No sites are listed yet.
About this study
Refractive errors and corneal astigmatism are associated with changes in angle kappa and corneal back elevation at the thinnest point in Pentacam.
The purpose of this study is to track:
The effect of anterior corneal astigmatism treatment on angle kappa and corneal back elevation.
Read the detailed description
This prospective observational study will be settled in Ain Shams University Hospital, Cairo, Egypt.
- Conditions
- Refractive Errors
- Medical subject headings
- Refractive Errors
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 |
|---|---|---|
| Cases with high myopic astigmatism | Cases having myopic astigmatism more than 1.5 diopter | |
| Cases with not high astigmatism | Cases having astigmatism less than 1.5 diopter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Track changes in angle kappa
Track changes in angle kappa with changes in corneal astigmatism
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsaiid, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166212
- Sponsor's protocol ID
- angle K relation e astigmatism
- Status last verified
- Dec 2023
- First submitted
- 19 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Angle Kappa and Corneal Back Elevations After Laser in Situ Keratomileusis in Myopic Astigmatism
- ClinicalTrials.gov ID
- NCT06166212
- Acronym / sponsor ID
- angle K relation e astigmatism
- Conditions
- Refractive Errors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 12 Dec 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.
Refractive errors and corneal astigmatism are associated with changes in angle kappa and corneal back elevation at the thinnest point in Pentacam.
The purpose of this study is to track:
The effect of anterior corneal astigmatism treatment on angle kappa and corneal back elevation.
Detailed description
This prospective observational study will be settled in Ain Shams University Hospital, Cairo, Egypt.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with high myopic astigmatism | – | –Cases having myopic astigmatism more than 1.5 diopter |
| Cases with not high astigmatism | – | –Cases having astigmatism less than 1.5 diopter |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- 2 groups
Key inclusion criteria (1 listed)
- Myopic astigmatism
Key exclusion criteria (1 listed)
- Corneal scar
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
Track changes in angle kappa
Time frame: through study completion, an average of 2 years
Track changes in angle kappa with changes in corneal astigmatism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
Related trials for Refractive Errors
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
Not yet recruiting
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
Refractive Errors
Not yet recruiting
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors, run by Ain Shams 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 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: status not confirmed, as of the sponsor's last update on 12 Dec 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 Mohamed Elsaiid (00201028518999, drmohammed1244@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Track changes in angle kappa (time frame: through study completion, an average of 2 years). 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 12 Dec 2023.