Corneal AstigmatismNCT03097302
Tomographic Analysis of Anterior, Posterior, Total Corneal Refractive Power Changes After Laser-assisted Keratotomy
An observational study of Corneal Astigmatism, run by University Clinic Frankfurt.
Trial summary
To analyze the effect of femtolaser-assisted keratotomy on corneal astigmatism (anterior, posterior and Total corneal refractive power) measured by Scheimpflug tomography after laser lens surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Astigmatism
- What is being tested?
- Laser keratotomy
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2013to 31 Jul 2014
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism during lens surgery
Who may be able to join
- Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism
Who cannot join
- Eyes with irregular corneal astigmatism such as keratoconus, previous corneal surgery, acute or chronic ophthalmic diseases of the anterior segment and intraoperative complications were not included in this study.
About this study
Official title: Tomographic Analysis of Anterior, Posterior and Total Corneal Refractive Power Changes After Femtosecond Laser-assisted Keratotomy After Laser Lens Surgery
To analyze the effect of femtolaser-assisted keratotomy on corneal astigmatism (anterior, posterior and Total corneal refractive power) measured by Scheimpflug tomography after laser lens surgery.
Read the detailed description
This study investigated patients' eyes with low to moderate total corneal refractive power determined with Scheimpflug tomography (Pentacam HR) after penetrating femtosecond laser-assisted keratotomy (pFLAK) and laser lens surgery. The anterior corneal astigmatism, posterior corneal astigmatism and total corneal refractive power were determined before, 1 month and 3 months after lens surgery. Vector analysis according to the Alpins' method was used to calculate surgically induced astigmatism (SIA).
- Conditions
- Corneal Astigmatism
- Being tested
- Laser keratotomy
- Keywords
- laser-assisted keratotomy, anterior astigmatism, posterior astigmatism, total corneal refractive power, nomogram
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser keratotomyProcedure or surgery
Penetrating femtosecond laser assisted keratotomy to treat preexisting corneal astigmatism during lens surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Total corneal refractive power at 3 months
Total corneal astigmatism (anterior and posterior astigmatism)
Measured: Before and 3 months after lens surgery
Secondary outcomes (2)
Change from Baseline Anterior corneal astigmatism at 3 months
Anterior corneal astigmatism
Measured: Before and 3 months after lens surgery
Change from Baseline Posterior corneal astigmatism at 3 months
Posterior corneal astigmatism
Measured: Before and 3 months after lens surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start6 Jun 2013
- Primary completion31 Jul 2014
- Study completion31 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal AstigmatismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Clinic Frankfurt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myriam Böhm, University Clinic Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097302
- Sponsor's protocol ID
- 140/13
- Status last verified
- Mar 2017
- First submitted
- 18 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Via a Publication in a reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tomographic Analysis of Anterior, Posterior and Total Corneal Refractive Power Changes After Femtosecond Laser-assisted Keratotomy After Laser Lens Surgery
- ClinicalTrials.gov ID
- NCT03097302
- Acronym / sponsor ID
- 140/13
- Conditions
- Corneal Astigmatism
- Keywords
- laser-assisted keratotomy, anterior astigmatism, posterior astigmatism, total corneal refractive power, nomogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Clinic FrankfurtUniversity, hospital or other
- Study start
- 6 Jun 2013 (actual)
- Primary completion
- 31 Jul 2014 (actual)
- Study completion
- 31 Jul 2014 (actual)
- First posted
- 31 Mar 2017 (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.
To analyze the effect of femtolaser-assisted keratotomy on corneal astigmatism (anterior, posterior and Total corneal refractive power) measured by Scheimpflug tomography after laser lens surgery.
Detailed description
This study investigated patients' eyes with low to moderate total corneal refractive power determined with Scheimpflug tomography (Pentacam HR) after penetrating femtosecond laser-assisted keratotomy (pFLAK) and laser lens surgery. The anterior corneal astigmatism, posterior corneal astigmatism and total corneal refractive power were determined before, 1 month and 3 months after lens surgery. Vector analysis according to the Alpins' method was used to calculate surgically induced astigmatism (SIA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism during lens surgery
Key inclusion criteria (1 listed)
- Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism
Key exclusion criteria (1 listed)
- Eyes with irregular corneal astigmatism such as keratoconus, previous corneal surgery, acute or chronic ophthalmic diseases of the anterior segment and intraoperative complications were not included in this study.
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 |
|---|---|---|
| Laser keratotomyPenetrating femtosecond laser assisted keratotomy to treat preexisting corneal astigmatism during lens surgery. | Procedure or surgery | – |
Primary outcome
Change from Baseline Total corneal refractive power at 3 months
Time frame: Before and 3 months after lens surgery
Total corneal astigmatism (anterior and posterior astigmatism)
2 secondary outcomes
Change from Baseline Anterior corneal astigmatism at 3 months
Time frame: Before and 3 months after lens surgery
Change from Baseline Posterior corneal astigmatism at 3 months
Time frame: Before and 3 months after lens surgery
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 31 Mar 2017.
- Individual participant dataSharing planned: Yes. Via a Publication in a reviewed journal.
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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 Corneal Astigmatism, run by University Clinic Frankfurt.
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 31 Mar 2017. 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?
Change from Baseline Total corneal refractive power at 3 months (time frame: Before and 3 months after lens surgery). 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 31 Mar 2017.