Refractive ErrorsNCT01663597
Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes
An observational study of Refractive Errors and Axial Length, Eye, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Aberrations play a significant role in the visual process and can be divided in lower-order and higher-order aberrations. The former can be measured using the commercially available IOL Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Axial Length, Eye, Corneal Wavefront Aberration
- How many people
- 160 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2012to May 2013
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participants will be selected by the Department of Clinical Pharmacology
Who may be able to join
- men and women aged between 40 and 60 years
- normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- normal ophthalmic findings unless the investigator considers an abnormality to be clinically irrelevant
Who cannot join
- presence of any corneal or retinal disease
- Dry eye syndrome
- high astigmatism (>1 diopter)
- history of refractive surgery
- abuse of alcoholic beverages
- participation in a clinical trial in the 3 weeks preceding the study
- symptoms of a clinically relevant illness in the 3 weeks before the study day
- pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Aberrations play a significant role in the visual process and can be divided in lower-order and higher-order aberrations. The former can be measured using the commercially available IOL Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity. Higher-order aberrations do not significantly influence visual acuity but affect the quality of vision and can cause halos, double vision, and night vision disturbances.
Background Cataract surgery has become a routine procedure in the developed countries. During this surgery, a foldable intraocular lens is usually inserted into the capsular bag. However, these lenses do not account for individual optical biometry data or aberrations. Therefore, it is important to provide data for ametropic and emmetropic eyes as this information might improve future intraocular lens design and lead to individually adapted lenses for yielding optimal visual acuity and quality results.
The aim of the present study is to clarify the correlation between refractive errors/axial eye length and spherical aberrations of the cornea.
- 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 |
|---|---|---|
| Cohort 1 | 40 subjects with high grarde myopia ranging from -10 diopters to -4.01 diopters | |
| Cohort 2 | 40 subjects with moderate myopia ranging from -4 diopters to -1.01 diopter | |
| Cohort 3 | 40 subjects with emmetropia, -1 diopter to +1 diopter | |
| Cohort 4 | 40 subjects with hyperopia, +1.01 diopter and more |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial eye length
Measured: 1 day
Secondary outcomes (6)
Refractive error
Measured: 1 day
Corneal radius
Measured: 1 day
Pupil diameter
Measured: 1 day
Anterior chamber depth
Measured: 1 day
Anterior corneal topography
Measured: 1 day
Corneal thickness map
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMay 2013
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.
- More trials run by Medical University of ViennaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663597
- Sponsor's protocol ID
- OPHTH-240512
- Status last verified
- Aug 2013
- First submitted
- 9 Aug 2012
- Last updated
- 29 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Biometry and Spherical Aberration in Ametropic and Emmetropic Eyes
- ClinicalTrials.gov ID
- NCT01663597
- Acronym / sponsor ID
- OPHTH-240512
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Aug 2012 (estimated)
- 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.
Aberrations play a significant role in the visual process and can be divided in lower-order and higher-order aberrations. The former can be measured using the commercially available IOL Master (Carl Zeiss Meditec AG, Germany) and have profound influence on visual acuity. Higher-order aberrations do not significantly influence visual acuity but affect the quality of vision and can cause halos, double vision, and night vision disturbances.
Background Cataract surgery has become a routine procedure in the developed countries. During this surgery, a foldable intraocular lens is usually inserted into the capsular bag. However, these lenses do not account for individual optical biometry data or aberrations. Therefore, it is important to provide data for ametropic and emmetropic eyes as this information might improve future intraocular lens design and lead to individually adapted lenses for yielding optimal visual acuity and quality results.
The aim of the present study is to clarify the correlation between refractive errors/axial eye length and spherical aberrations of the cornea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –40 subjects with high grarde myopia ranging from -10 diopters to -4.01 diopters |
| Cohort 2 | – | –40 subjects with moderate myopia ranging from -4 diopters to -1.01 diopter |
| Cohort 3 | – | –40 subjects with emmetropia, -1 diopter to +1 diopter |
| Cohort 4 | – | –40 subjects with hyperopia, +1.01 diopter and more |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants will be selected by the Department of Clinical Pharmacology
Key inclusion criteria (3 listed)
- men and women aged between 40 and 60 years
- normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- normal ophthalmic findings unless the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (8 listed)
- presence of any corneal or retinal disease
- Dry eye syndrome
- high astigmatism (>1 diopter)
- history of refractive surgery
- abuse of alcoholic beverages
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
Axial eye length
Time frame: 1 day
6 secondary outcomes
Refractive error
Time frame: 1 day
Corneal radius
Time frame: 1 day
Pupil diameter
Time frame: 1 day
Anterior chamber depth
Time frame: 1 day
Anterior corneal topography
Time frame: 1 day
Corneal thickness map
Time frame: 1 day
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 29 Aug 2013.
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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.
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 Axial Length, Eye, run by Medical University of Vienna at 1 site in Austria.
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 8 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 29 Aug 2013. 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 Austria. 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?
Axial eye length (time frame: 1 day). 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 Aug 2013.