CataractNCT02649257
Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)
A study testing cataract surgery, intraocular lens (MC 6125 AS) and capsular tension ring (CTR 13/11) in people with Cataract, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to observe the axial IOL rotation after surgery with a capsular tension ring (CTR) and a MC6125 AS IOL. At the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. 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, intraocular lens (MC 6125 AS) and capsular tension ring (CTR 13/11)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2014to May 2015
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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, Vianne, 1090
About this study
The purpose of this study is to observe the axial IOL rotation after surgery with a capsular tension ring (CTR) and a MC6125 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, intraocular lens (MC 6125 AS), capsular tension ring (CTR 13/11)
- Keywords
- IOL rotation, capsular tension ring, IOL rotational stability
- 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
intraocular lens (MC 6125 AS)Device
capsular tension ring (CTR 13/11)Device
| Study group | Role | What they receive |
|---|---|---|
| MC 6125 AS IOL + CTR | Experimental | All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS). Receives: Procedure: cataract surgery; Device: intraocular lens (MC 6125 AS); Device: capsular tension ring (CTR 13/11) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL rotation
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 posted7 Jan 2016 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionMay 2015
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT02649257
- Sponsor's protocol ID
- EK-Nr.: 1435/2014
- Status last verified
- Jan 2016
- First submitted
- 22 Dec 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)
- ClinicalTrials.gov ID
- NCT02649257
- Acronym / sponsor ID
- EK-Nr.: 1435/2014
- Conditions
- Cataract
- Keywords
- IOL rotation, capsular tension ring, IOL rotational stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Jan 2016 (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 observe the axial IOL rotation after surgery with a capsular tension ring (CTR) and a MC6125 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MC 6125 AS IOL + CTR | Experimental | Procedure: cataract surgery, Device: intraocular lens (MC 6125 AS), Device: capsular tension ring (CTR 13/11)All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS). |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 surgery | Procedure or surgery | MC 6125 AS IOL + CTR |
| intraocular lens (MC 6125 AS) | Device | MC 6125 AS IOL + CTR |
| capsular tension ring (CTR 13/11) | Device | MC 6125 AS IOL + CTR |
Primary outcome
IOL rotation
Time frame: 6 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 12 Jan 2016.
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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?
A study testing cataract surgery, intraocular lens (MC 6125 AS) and capsular tension ring (CTR 13/11) in people with 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 12 Jan 2016. 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 12 Jan 2016.