AstigmatismNCT04776057
Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation
A study testing catarct surgery with toric intra ocular lenses in people with Astigmatism, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation. 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?
- catarct surgery with toric intra ocular lenses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2021to 30 Dec 2023
- 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
- Cataract
- Age 21 and older
- Regular corneal astigmatism ≥ 1.5 D
- written informed consent prior to surgery
Who cannot join
- Relevant other ophthalmic diseases such as: pseudoexfoliation, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
- High myopia (> 29 mm AL)
- 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
Hanusch Hospital, Department of Ophthalmology
Vienna, 1140
Oliver Findl, Prof. MD, +43 1 91021 57564, office@viros.at
About this study
To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.
Read the detailed description
To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.
- Conditions
- Astigmatism
- Being tested
- catarct surgery with toric intra ocular lenses
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catarct surgery with toric intra ocular lensesOther
rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation
| Study group | Role | What they receive |
|---|---|---|
| lying | Other | after cataract lying for 1 hour Receives: Other: catarct surgery with toric intra ocular lenses |
| sitting, walkin | Other | after cataract sitting or walking for 1 hour Receives: Other: catarct surgery with toric intra ocular lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of toric IOL rotation between both groups (mean ≠ SD)
Aim is to see if the lying down after the operation lowers the risk of toric IOL rotation compared to sitting down
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Feb 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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.
- 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
- 14 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
- NCT04776057
- Sponsor's protocol ID
- EK 20-302-1220
- Status last verified
- Oct 2022
- First submitted
- 25 Feb 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotation Stability of Toric Intraocularlens (IOL) Compared Sitting Against Lying After Cataract Operation
- ClinicalTrials.gov ID
- NCT04776057
- Acronym / sponsor ID
- EK 20-302-1220
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 Mar 2021 (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 assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.
Detailed description
To assess the rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lying | Other | Other: catarct surgery with toric intra ocular lensesafter cataract lying for 1 hour |
| sitting, walkin | Other | Other: catarct surgery with toric intra ocular lensesafter cataract sitting or walking for 1 hour |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cataract
- Age 21 and older
- Regular corneal astigmatism ≥ 1.5 D
- written informed consent prior to surgery
Key exclusion criteria (4 listed)
- Relevant other ophthalmic diseases such as: pseudoexfoliation, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
- High myopia (> 29 mm AL)
- 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 |
|---|---|---|
| catarct surgery with toric intra ocular lensesrotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation | Other | lying, sitting, walkin |
Primary outcome
Comparison of toric IOL rotation between both groups (mean ≠ SD)
Time frame: 1 Year
Aim is to see if the lying down after the operation lowers the risk of toric IOL rotation compared to sitting down
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
Related trials for Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
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 catarct surgery with toric intra ocular lenses in people with 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 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: status not confirmed, as of the sponsor's last update on 13 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julius Hienert, MD (+436646415113, j.hienert@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of toric IOL rotation between both groups (mean ≠ SD) (time frame: 1 Year). 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 13 Oct 2022.