CataractNCT02208232
Observation of Rotation of an Intraocular Lens
An observational study of Cataract, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125 AS IOL. At the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2012to Dec 2012
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eyes of patients with uni- or bilateral cataract applying for cataract surgery at the Department of Ophthalmology, Medical University Vienna.
Who may be able to join
- Uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
Who cannot join
- Preceding ocular surgery or trauma
- Recurrent intraocular inflammation of unknown etiology
- Uncontrolled glaucoma
- Uncontrolled systemic or ocular disease
- Blind fellow eye
- Microphthalmus
Show all 11Show fewer
- Corneal abnormality
- History of uveitis/iritis
- Iris neovascularization
- Pseudoexfoliation
- Proliferative diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Ophthalmology and Optometry of the Medical University Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Observation of Rotation of the MC 6125 AS Intraocular Lens
The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125 AS IOL.
At the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. Rotational stability of the IOL is assessed using retroillumination images with a method to avoid bias from cyclorotation or head tilt.
- Conditions
- Cataract
- Being tested
- cataract surgery
- Keywords
- IOL rotation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
cataract surgery with implantation of intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| MC 6125 AS IOL | cataract surgery with implantation of intraocular lens MC 6125 AS in one eye Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL rotation
The rotation of the IOLs over the first 6 postoperative months
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 posted5 Aug 2014 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Menapace, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208232
- Sponsor's protocol ID
- EK Nr: 1267/2012
- Status last verified
- Aug 2014
- First submitted
- 27 Mar 2014
- Last updated
- 5 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Rotation of the MC 6125 AS Intraocular Lens
- ClinicalTrials.gov ID
- NCT02208232
- Acronym / sponsor ID
- EK Nr: 1267/2012
- Conditions
- Cataract
- Keywords
- IOL rotation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Aug 2014 (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.
The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125 AS IOL.
At the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. Rotational stability of the IOL is assessed using retroillumination images with a method to avoid bias from cyclorotation or head tilt.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MC 6125 AS IOL | – | Procedure: cataract surgerycataract surgery with implantation of intraocular lens MC 6125 AS in one eye |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eyes of patients with uni- or bilateral cataract applying for cataract surgery at the Department of Ophthalmology, Medical University Vienna.
Key inclusion criteria (1 listed)
- Uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
Key exclusion criteria (11 listed)
- Preceding ocular surgery or trauma
- Recurrent intraocular inflammation of unknown etiology
- Uncontrolled glaucoma
- Uncontrolled systemic or ocular disease
- Blind fellow eye
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 |
|---|---|---|
| cataract surgerycataract surgery with implantation of intraocular lens | Procedure or surgery | MC 6125 AS IOL |
Primary outcome
IOL rotation
Time frame: 6 months
The rotation of the IOLs over the first 6 postoperative months
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 5 Aug 2014.
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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 Cataract, 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 1 inclusion and 11 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 5 Aug 2014. 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?
IOL rotation (time frame: 6 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 5 Aug 2014.