AstigmatismNCT06179355
Limbal Astigmatic Keratotomy to Correct High Degrees of Astigmatism After Phacoemulsification
A study testing manual astigmatic keratotomy and femtosecond laser astigmatic keratotomy in people with Astigmatism, run by Assiut University at 1 site in Egypt.
Trial summary
Compare manually performed Astigmatic Keratotomy to femtosecond laser astigmatic keratotomy to manage corneal astigmatism more than three diopters after phacoemulsification. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- manual astigmatic keratotomy and femtosecond laser astigmatic keratotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Jan 2024
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Possibility to have informed consent and attendance of all study visits.
- Patients who have undergone conventional phacoemulsification at least one month ago.
- Clear cornea.
- Astigmatism more than 0.5 diopters.
Who cannot join
- Corneal opacity.
- History of corneal surgery.
- Thin cornea.
- Astigmatism equal to or less than 0.5 diopters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Manual Limbal Astigmatic Keratotomy and Femtosecond Laser-guided Limbal Astigmatic Keratotomy for Correction of Astigmatism More Than Three Diopters After Phacoemulsification
Compare manually performed Astigmatic Keratotomy to femtosecond laser astigmatic keratotomy to manage corneal astigmatism more than three diopters after phacoemulsification.
Read the detailed description
create circumferential corneal incisions, following the limbal curvature, at 1-1.5 mm anterior to the limbus, manually and by using femtosecond laser to correct corneal astigmatism more than three diopters after phacoemulsification.
- Conditions
- Astigmatism
- Being tested
- manual astigmatic keratotomy, femtosecond laser astigmatic keratotomy
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual astigmatic keratotomyProcedure or surgery
manual astigmatic keratotomy using a diamond knife
femtosecond laser astigmatic keratotomyProcedure or surgery
astigmatic keratotomy using femtosecond lase
| Study group | Role | What they receive |
|---|---|---|
| manual Astigmatic Keratotomy | Experimental | manual limbal Astigmatic Keratotomy using a diamond knife group Receives: Procedure: manual astigmatic keratotomy |
| femtosecond laser Astigmatic Keratotomy | Experimental | Femtosecond laser-guided astigmatic keratotomy group Receives: Procedure: femtosecond laser astigmatic keratotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
astigmatism (Keratometric reading)
diopters of the astigmatism after the procedure measured by Pentacam
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Oct 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Rashwan, Assiut University
- Investigators
- Ashraf Rashwan, MD, Principal investigator, assiut univrsity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179355
- Sponsor's protocol ID
- 1727367365
- Status last verified
- Oct 2023
- First submitted
- 10 Dec 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Manual Limbal Astigmatic Keratotomy and Femtosecond Laser-guided Limbal Astigmatic Keratotomy for Correction of Astigmatism More Than Three Diopters After Phacoemulsification
- ClinicalTrials.gov ID
- NCT06179355
- Acronym / sponsor ID
- 1727367365
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 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.
Compare manually performed Astigmatic Keratotomy to femtosecond laser astigmatic keratotomy to manage corneal astigmatism more than three diopters after phacoemulsification.
Detailed description
create circumferential corneal incisions, following the limbal curvature, at 1-1.5 mm anterior to the limbus, manually and by using femtosecond laser to correct corneal astigmatism more than three diopters after phacoemulsification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual Astigmatic Keratotomy | Experimental | Procedure: manual astigmatic keratotomymanual limbal Astigmatic Keratotomy using a diamond knife group |
| femtosecond laser Astigmatic Keratotomy | Experimental | Procedure: femtosecond laser astigmatic keratotomyFemtosecond laser-guided astigmatic keratotomy group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Possibility to have informed consent and attendance of all study visits.
- Patients who have undergone conventional phacoemulsification at least one month ago.
- Clear cornea.
- Astigmatism more than 0.5 diopters.
Key exclusion criteria (4 listed)
- Corneal opacity.
- History of corneal surgery.
- Thin cornea.
- Astigmatism equal to or less than 0.5 diopters.
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 |
|---|---|---|
| manual astigmatic keratotomymanual astigmatic keratotomy using a diamond knife | Procedure or surgery | manual Astigmatic Keratotomy |
| femtosecond laser astigmatic keratotomyastigmatic keratotomy using femtosecond lase | Procedure or surgery | femtosecond laser Astigmatic Keratotomy |
Primary outcome
astigmatism (Keratometric reading)
Time frame: three month
diopters of the astigmatism after the procedure measured by Pentacam
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 5 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Ashraf Rashwan, MD principal investigator
assiut univrsity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual astigmatic keratotomy and femtosecond laser astigmatic keratotomy in people with Astigmatism, run by Assiut 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 4 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: finished, as of the sponsor's last update on 5 Mar 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?
astigmatism (Keratometric reading) (time frame: three month). 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 5 Mar 2024.