CataractLow AstiNCT03538964
Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism
A study testing toric intraocular lens and non toric intraocular lens in people with Cataract and Astigmatism, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Comparison of the astigmatism reducing effect of a toric IOL with a non toric IOL in eyes with low corneal astigmatism. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- toric intraocular lens and non toric intraocular lens
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 2 May 2018to 1 Aug 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cataract
- Age 21 and older
- Regular corneal astigmatism 0.5D up to 1.5 D and difference between eyes not more than 0.75D
- written informed consent prior to surgery
Who cannot join
- relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
- Irregular corneal astigmatism on corneal topography
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
Julius Hienert, MD, 01 90121-57564, j.hienert@viros.at
Nino Hirnschall, MD, 01 90121-57564, nino.hirnschall@wgkk.at
About this study
Comparison of the astigmatism reducing effect of a toric IOL with a non toric IOL in eyes with low corneal astigmatism.
Read the detailed description
With increasing demands of patients concerning refractive outcome after cataract surgery, toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more widely to cataract surgery. Originally, toric IOLs were used mainly for patients with high degrees of astigmatism. Since a couple of years, toric IOLs are available from numerous manufacturers to correct moderate amounts of astigmatism which are much more prevalent with about 8% having a corneal astigmatism of 2.0D or more in the cataract population. 5Using toric IOLs for these eyes results in less spectacle dependence of patients due to the astigmatic correction. Other astigmatism reducing techniques, such as peripheral corneal relaxing incisions and opposite clear corneal incisions were shown to be less predictable. Although the use of toric IOLs became the gold standard to correct corneal astigmatism during cataract surgery , there is still uncertainty, if low astigmatism should be corrected. Visser et al. showed that moderate astigmatism of than 1.5D should be corrected for monofocal IOLs and Hayashi showed that remaining astigmatism of 1.0D already decreases visual quality in eyes with multifocal IOLs. Although correction of low corneal astigmatism appears to be beneficial, some hurdles have to be taken into account. In eyes with low corneal astigmatism the accuracy of measuring the astigmatism meridian is relatively low. Furthermore, different corneal measurement techniques are not always comparable and it is difficult to know, which device shows the correct amount of astigmatism. Additionally, the correction of the spherical equivalent is of high importance, as a refractive surprise will also attenuate the astigmatism reducing effect of the toric IOL. Aim of this study is to assess, if toric IOLs are useful in patients with low amounts of corneal astigmatism and to quantify the sources of error in toric IOL power calculation.
- Conditions
- Cataract, Astigmatism
- Being tested
- toric intraocular lens, non toric intraocular lens
- Keywords
- Cataract, Low Astigmatism
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toric intraocular lensProcedure or surgery
cataract surgery with implantation of an toric intraocular lens
non toric intraocular lensProcedure or surgery
cataract surgery with implantation of a non toric intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Toric intraocular lens (IOL) | Active comparator | toric intraocular lens for low astigmatism correction Receives: Procedure: toric intraocular lens |
| Non toric intraocular lens (IOL) | Sham comparator | non toric intraocular lens Receives: Procedure: non toric intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective refraction to detect remaining astigmatism (in Diopters) between both groups
Measured: 12 months
Secondary outcomes (4)
Biometrical measurement of axial length (in mm), anterior chamber depth (in mm), corneal astigmatism (radii and axial degrees)
Measured: 12 months
Purkinjemeter measurement of Tilt (in degrees) and Decentration (in degrees) of the intraocular lens
Measured: 12 months
Wavefront analysis of high order aberrations (root mean square, in microns)
Measured: 12 months
Questionnaire to asses patients subjective satisfaction with visual outcome
In the questionnaire the patient has to choose if different tasks (e.g. reading, driving, watching TV) are easier for him/ her with the right eye, the left eye, or if there is no difference between both eyes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start2 May 2018
- Primary completion2 May 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538964
- Sponsor's protocol ID
- Low Asti
- Acronym
- Low Asti
- Status last verified
- Oct 2019
- First submitted
- 30 Apr 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism
- ClinicalTrials.gov ID
- NCT03538964
- Acronym / sponsor ID
- Low Asti / Low Asti
- Conditions
- Cataract, Astigmatism
- Keywords
- Cataract, Low Astigmatism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 2 May 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 29 May 2018 (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.
Comparison of the astigmatism reducing effect of a toric IOL with a non toric IOL in eyes with low corneal astigmatism.
Detailed description
With increasing demands of patients concerning refractive outcome after cataract surgery, toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more widely to cataract surgery. Originally, toric IOLs were used mainly for patients with high degrees of astigmatism. Since a couple of years, toric IOLs are available from numerous manufacturers to correct moderate amounts of astigmatism which are much more prevalent with about 8% having a corneal astigmatism of 2.0D or more in the cataract population. 5Using toric IOLs for these eyes results in less spectacle dependence of patients due to the astigmatic correction. Other astigmatism reducing techniques, such as peripheral corneal relaxing incisions and opposite clear corneal incisions were shown to be less predictable. Although the use of toric IOLs became the gold standard to correct corneal astigmatism during cataract surgery , there is still uncertainty, if low astigmatism should be corrected. Visser et al. showed that moderate astigmatism of than 1.5D should be corrected for monofocal IOLs and Hayashi showed that remaining astigmatism of 1.0D already decreases visual quality in eyes with multifocal IOLs. Although correction of low corneal astigmatism appears to be beneficial, some hurdles have to be taken into account. In eyes with low corneal astigmatism the accuracy of measuring the astigmatism meridian is relatively low. Furthermore, different corneal measurement techniques are not always comparable and it is difficult to know, which device shows the correct amount of astigmatism. Additionally, the correction of the spherical equivalent is of high importance, as a refractive surprise will also attenuate the astigmatism reducing effect of the toric IOL. Aim of this study is to assess, if toric IOLs are useful in patients with low amounts of corneal astigmatism and to quantify the sources of error in toric IOL power calculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toric intraocular lens (IOL) | Active comparator | Procedure: toric intraocular lenstoric intraocular lens for low astigmatism correction |
| Non toric intraocular lens (IOL) | Sham comparator | Procedure: non toric intraocular lensnon toric intraocular lens |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cataract
- Age 21 and older
- Regular corneal astigmatism 0.5D up to 1.5 D and difference between eyes not more than 0.75D
- written informed consent prior to surgery
Key exclusion criteria (3 listed)
- relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
- Irregular corneal astigmatism on corneal topography
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
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 |
|---|---|---|
| toric intraocular lenscataract surgery with implantation of an toric intraocular lens | Procedure or surgery | Toric intraocular lens (IOL) |
| non toric intraocular lenscataract surgery with implantation of a non toric intraocular lens | Procedure or surgery | Non toric intraocular lens (IOL) |
Primary outcome
Subjective refraction to detect remaining astigmatism (in Diopters) between both groups
Time frame: 12 months
4 secondary outcomes
Biometrical measurement of axial length (in mm), anterior chamber depth (in mm), corneal astigmatism (radii and axial degrees)
Time frame: 12 months
Purkinjemeter measurement of Tilt (in degrees) and Decentration (in degrees) of the intraocular lens
Time frame: 12 months
Wavefront analysis of high order aberrations (root mean square, in microns)
Time frame: 12 months
Questionnaire to asses patients subjective satisfaction with visual outcome
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing toric intraocular lens and non toric intraocular lens in people with Cataract and Astigmatism, run by Prim. Prof. Dr. Oliver Findl, MBA 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 4 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 2 Oct 2019. 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. Some participants in this study may receive a placebo. 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?
Contact Julius Hienert, MD (+43 01 91021 57564, j.hienert@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective refraction to detect remaining astigmatism (in Diopters) between both groups (time frame: 12 months). 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 2 Oct 2019.