Refractive ErrorsNCT03893838
Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery
An observational study of Refractive Errors and Aberration, Corneal Wavefront, run by Wrocław University of Science and Technology at 1 site in Poland.
Trial summary
Refractive surgeries can be divided into two distinct categories: 1) corneal surgeries (superficial and deep procedures) carried on the surface of the eye and 2) lens surgeries (phakic IOL, refractive lens exchange) - an intraocular intervention, performed in the anterior or posterior chamber or on the lens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Aberration, Corneal Wavefront
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2019to 1 Feb 2024
- How long will I take part?
- 24 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients after refractive surgery
Who may be able to join
- patient after corneal refractive surgery at least for 4 months
- post surgical refraction within +/- 0.75 diopter of spherical and +/- 1.0 diopter of cylindrical error
- willing and able to understand and sign an informed consent form.
Who cannot join
- patient unable to participate in the study
- any corneal diseases, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus
- corneal macula and obvious pannus; current enrolment in another clinical trial/research project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery - Preliminary Study Assessing Their Prevalence, Methods of Reductions of Symptoms and Time-dependent Changes in Patients Symptoms
Refractive surgeries can be divided into two distinct categories: 1) corneal surgeries (superficial and deep procedures) carried on the surface of the eye and 2) lens surgeries (phakic IOL, refractive lens exchange) - an intraocular intervention, performed in the anterior or posterior chamber or on the lens. In the proposed protocol focus is on the corneal refractive surgeries impact on monochromatic higher-order aberrations on the one hand and chromatic aberrations on the other. During the surgery in order to get the patient emmetropic, refractive surgery corrects optical defects by decreasing aberrations of lower orders ) simultaneously increases high-order aberrations (that is perceived by the patient as halo, glare or starburst). Informations about prevalence and causes of higher order aberrations after refractive surgery are numerous but there is no information about chromatic aberrations.
- Conditions
- Refractive Errors, Aberration, Corneal Wavefront
- Medical subject headings
- Refractive Errors, Corneal Wavefront Aberration
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 |
|---|---|---|
| Post refractive surgery without HOA | Patients post refractive surgery that do not complain on the high order aberrations such as glare, halo and starburst. | |
| Post refractive surgery with HOA | Patients post refractive surgery that do complain on the high order aberrations such as glare, halo and starburst. | |
| Post refractive surgery with rainbow HOA | Patients post refractive surgery that do complain on: 1. the high order aberrations such as glare, halo and starburst but with the chromatic aureola 2. difficulties working with LCD projectors, monitors, cell phones and tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of high order and chromatic aberrations after refractive surgery
number of high order and chromatic aberrations after refractive surgery
Measured: 6 months
Chromoretinoscopy for near (MEM) and distance
Conducted with a modified by researchers retinoscopy with distinct filters
Measured: 6 months
Aberrometry reading for corneal HOA
Conducted with aberrometer and corneal tomography
Measured: 6 months
Transverse chromatic aberration
Conducted with a modified by researchers aniseikonia test (with red and green lenses)
Measured: 6 months
Secondary outcomes (3)
Change in Hue 100 test
without and after the introduction of glasses with accommodation support, a blue light filter or concave lenses up to -0,5 diopter
Measured: 6 months
Change of contrast sensitivity for near vision
without and after the introduction of glasses with accommodation support, a blue light filter or concave lenses up to -0,5 diopter
Measured: 6 months
Visual Function Questionaire 25
Conducted with VFQ-25 test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2022
- Study completion1 Feb 2024 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Wrocław University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University
- Responsible party
- Sponsor
- Investigators
- Joanna Przeździecka-Dołyk, PhD, Principal investigator, Wrocław University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893838
- Sponsor's protocol ID
- ST001.2018
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We intend to share anonymised data
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery - Preliminary Study Assessing Their Prevalence, Methods of Reductions of Symptoms and Time-dependent Changes in Patients Symptoms
- ClinicalTrials.gov ID
- NCT03893838
- Acronym / sponsor ID
- ST001.2018
- Conditions
- Refractive Errors, Aberration, Corneal Wavefront
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wrocław University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wroclaw Medical University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 28 Mar 2019 (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 surgeries can be divided into two distinct categories: 1) corneal surgeries (superficial and deep procedures) carried on the surface of the eye and 2) lens surgeries (phakic IOL, refractive lens exchange) - an intraocular intervention, performed in the anterior or posterior chamber or on the lens. In the proposed protocol focus is on the corneal refractive surgeries impact on monochromatic higher-order aberrations on the one hand and chromatic aberrations on the other. During the surgery in order to get the patient emmetropic, refractive surgery corrects optical defects by decreasing aberrations of lower orders ) simultaneously increases high-order aberrations (that is perceived by the patient as halo, glare or starburst). Informations about prevalence and causes of higher order aberrations after refractive surgery are numerous but there is no information about chromatic aberrations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post refractive surgery without HOA | – | –Patients post refractive surgery that do not complain on the high order aberrations such as glare, halo and starburst. |
| Post refractive surgery with HOA | – | –Patients post refractive surgery that do complain on the high order aberrations such as glare, halo and starburst. |
| Post refractive surgery with rainbow HOA | – | –Patients post refractive surgery that do complain on: 1. the high order aberrations such as glare, halo and starburst but with the chromatic aureola 2. difficulties working with LCD projectors, monitors, cell phones and tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after refractive surgery
Key inclusion criteria (3 listed)
- patient after corneal refractive surgery at least for 4 months
- post surgical refraction within +/- 0.75 diopter of spherical and +/- 1.0 diopter of cylindrical error
- willing and able to understand and sign an informed consent form.
Key exclusion criteria (3 listed)
- patient unable to participate in the study
- any corneal diseases, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus
- corneal macula and obvious pannus; current enrolment in another clinical trial/research project
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
number of high order and chromatic aberrations after refractive surgery
Time frame: 6 months
number of high order and chromatic aberrations after refractive surgery
Chromoretinoscopy for near (MEM) and distance
Time frame: 6 months
Conducted with a modified by researchers retinoscopy with distinct filters
Aberrometry reading for corneal HOA
Time frame: 6 months
Conducted with aberrometer and corneal tomography
Transverse chromatic aberration
Time frame: 6 months
Conducted with a modified by researchers aniseikonia test (with red and green lenses)
3 secondary outcomes
Change in Hue 100 test
Time frame: 6 months
Change of contrast sensitivity for near vision
Time frame: 6 months
Visual Function Questionaire 25
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Undecided. We intend to share anonymised data
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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.
Joanna Przeździecka-Dołyk, PhD principal investigator
Wrocław University of Science and Technology
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 Refractive Errors and Aberration, Corneal Wavefront, run by Wrocław University of Science and Technology at 1 site in Poland.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. 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 Poland. 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?
Results are not available in the source record.
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?
number of high order and chromatic aberrations after refractive surgery (time frame: 6 months). The study lists 4 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 29 Mar 2022.