Lasik Eye SurgeryNCT06806306
Assessment of the Preoperative Risk Factors for the Development of Post-LASIK Ectasia
An observational study of Lasik Eye Surgery, run by Al-Azhar University.
Trial summary
: Laser-assisted in situ keratomileusis (LASIK) is one of the most widely performed refractive surgeries, offering effective and long-lasting correction for visual refractive errors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lasik Eye Surgery
- What is being tested?
- LASIK
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2013to 25 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: LASIK patients
Who may be able to join
- Clinical diagnosis of corneal ectasia was made by progressive central or inferior corneal steepening, increased myopia and/or astigmatism, and decreased visual acuity
Who cannot join
- Subjects who had glaucoma diagnosis, other corneal surgeries (other than LASIK), and central corneal opacity
About this study
: Laser-assisted in situ keratomileusis (LASIK) is one of the most widely performed refractive surgeries, offering effective and long-lasting correction for visual refractive errors. While LASIK has a high success rate and is generally safe, post-LASIK ectasia remains a rare but serious complication that compromises visual outcomes. Several risk factors for post-LASIK ectasia have been identified. The aim of the present study is to determine the preoperative risk factors for the development of post-LASIK ectasia.
- Conditions
- Lasik Eye Surgery
- Being tested
- LASIK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIKProcedure or surgery
Laser-assisted in situ keratomileusis is one of the most widely performed refractive surgeries for correcting myopia, hyperopia, and astigmatism
What is being measured
The primary outcome is the main question the study is designed to answer.
Randleman ectasia score
Measured: At the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Oct 2013
- Primary completion1 Aug 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lasik Eye SurgeryStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Shaban Abdella, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806306
- Sponsor's protocol ID
- Post-LASIK Ectasia
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Preoperative Risk Factors for the Development of Post-LASIK Ectasia
- ClinicalTrials.gov ID
- NCT06806306
- Acronym / sponsor ID
- Post-LASIK Ectasia
- Conditions
- Lasik Eye Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 4 Feb 2025 (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.
: Laser-assisted in situ keratomileusis (LASIK) is one of the most widely performed refractive surgeries, offering effective and long-lasting correction for visual refractive errors. While LASIK has a high success rate and is generally safe, post-LASIK ectasia remains a rare but serious complication that compromises visual outcomes. Several risk factors for post-LASIK ectasia have been identified. The aim of the present study is to determine the preoperative risk factors for the development of post-LASIK ectasia.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- LASIK patients
Key inclusion criteria (1 listed)
- Clinical diagnosis of corneal ectasia was made by progressive central or inferior corneal steepening, increased myopia and/or astigmatism, and decreased visual acuity
Key exclusion criteria (1 listed)
- Subjects who had glaucoma diagnosis, other corneal surgeries (other than LASIK), and central 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 |
|---|---|---|
| LASIKLaser-assisted in situ keratomileusis is one of the most widely performed refractive surgeries for correcting myopia, hyperopia, and astigmatism | Procedure or surgery | – |
Primary outcome
Randleman ectasia score
Time frame: At the baseline
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 4 Feb 2025.
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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 Lasik Eye Surgery, run by Al-Azhar 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: finished, as of the sponsor's last update on 4 Feb 2025. 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?
Randleman ectasia score (time frame: At the baseline). 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 4 Feb 2025.