Intraocular Lens RotationConTRolNCT04226196
Rotational Stability of a Hydrophobic Acrylic Plate Haptic Intraocular Lens Using a Capsular Tension Ring - An Intraindividual Comparative Study
A study testing Implantation of an intraocular lens in people with Intraocular Lens Rotation and Capsular Tension Ring, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The present study should investigate the influence of a capsular tension ring on postoperative rotational stability of a plate haptic hydrophilic acrylic intraocular lens. All patients will be operated on both eyes in one occasion. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Intraocular Lens Rotation, Capsular Tension Ring
- What is being tested?
- Implantation of an intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteAustria
- Study dates
- 27 Jan 2020to Apr 2021
- 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 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
- Need for spherical IOL correction between +0.00 and +32.00 D
- Pupil dilation of ≥ 7.0 mm
- Age 45 to 95
Who cannot join
- Corneal abnormality (Corneal scaring)
- Preceding ocular surgery or trauma
- Uncontrolled glaucoma
- Proliferative diabetic retinopathy
- Iris neovascularization
- History of uveitis/iritis
Show all 10Show fewer
- Microphthalmus
- Recurrent intraocular inflammation of unknown etiology Uncontrolled systemic or ocular disease
- Pregnancy
- Lactation
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna Allgemeines Krankenhaus
Vienna, 1090
Rupert Menapace, Prof., 014040066300, rupert.menapace@meduniwien.ac.at
About this study
The present study should investigate the influence of a capsular tension ring on postoperative rotational stability of a plate haptic hydrophilic acrylic intraocular lens. All patients will be operated on both eyes in one occasion. Both eyes receive a Zeiss 409MP plate haptic intraocular lens, while only on eye receives an additional capsular tension ring. Follow up visits take place 1 hour, 1 week, 1 month and 4 to 7 months after surgery. At the follow up visits, the actual IOL axis will be determined by retroillumination photography. IOL centration and tilt will be determined by anterior segment SS-OCT Casia II. IOLs will be implanted in 4 different axis 0 +/- 10 degrees, 45 +/- 10 degrees, 90 +/- 10 degrees, 135 +/- 10 degrees. IOL rotation, decentration and tilt then will be compared intraindividually.
- Conditions
- Intraocular Lens Rotation, Capsular Tension Ring
- Being tested
- Implantation of an intraocular lens
- Keywords
- Intraocular lens rotation, capsular tension ring, postoperative tilt & decentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of an intraocular lensDevice
Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.
| Study group | Role | What they receive |
|---|---|---|
| Axis 0 | Experimental | IOL Implantation at the 0 +/- 10 degrees axis Receives: Device: Implantation of an intraocular lens |
| Axis 45 | Experimental | IOL Implantation at the 45 +/- 10 degrees axis Receives: Device: Implantation of an intraocular lens |
| Axis 90 | Experimental | IOL Implantation at the 90 +/- 10 degrees axis Receives: Device: Implantation of an intraocular lens |
| Axis 135 | Experimental | IOL Implantation at the 135 +/- 10 degrees axis Receives: Device: Implantation of an intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of axial intraocular lens position
Change in axis position of an intraocular lens Zeiss 409 MP from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)
Measured: 7 months
Secondary outcomes (4)
Decentration
Decentration of the intraocular lens will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in millimeter"
Measured: 7 months
Tilt
Tilt of the intraocular lens will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"
Measured: 7 months
Anterior chamber depth
The anterior chamber depth (Axial position of the IOL) of the intraocular lens will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in millimeter
Measured: 7 months
Best corrected visual acuity (BCVA)
BCVA will be measured at 1 week, 1 month and 4 to 7 months. The BCVA will be described as the minimum angle of resolution (logMar)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start27 Jan 2020
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Lens RotationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (estimated)
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
- NCT04226196
- Sponsor's protocol ID
- ConTRol
- Acronym
- ConTRol
- Status last verified
- Apr 2020
- First submitted
- 9 Jan 2020
- Last updated
- 15 Apr 2020
- 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 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Stability of a Hydrophobic Acrylic Plate Haptic Intraocular Lens Using a Capsular Tension Ring - An Intraindividual Comparative Study
- ClinicalTrials.gov ID
- NCT04226196
- Acronym / sponsor ID
- ConTRol / ConTRol
- Conditions
- Intraocular Lens Rotation, Capsular Tension Ring
- Keywords
- Intraocular lens rotation, capsular tension ring, postoperative tilt & decentration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 13 Jan 2020 (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.
The present study should investigate the influence of a capsular tension ring on postoperative rotational stability of a plate haptic hydrophilic acrylic intraocular lens. All patients will be operated on both eyes in one occasion. Both eyes receive a Zeiss 409MP plate haptic intraocular lens, while only on eye receives an additional capsular tension ring. Follow up visits take place 1 hour, 1 week, 1 month and 4 to 7 months after surgery. At the follow up visits, the actual IOL axis will be determined by retroillumination photography. IOL centration and tilt will be determined by anterior segment SS-OCT Casia II. IOLs will be implanted in 4 different axis 0 +/- 10 degrees, 45 +/- 10 degrees, 90 +/- 10 degrees, 135 +/- 10 degrees. IOL rotation, decentration and tilt then will be compared intraindividually.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Axis 0 | Experimental | Device: Implantation of an intraocular lensIOL Implantation at the 0 +/- 10 degrees axis |
| Axis 45 | Experimental | Device: Implantation of an intraocular lensIOL Implantation at the 45 +/- 10 degrees axis |
| Axis 90 | Experimental | Device: Implantation of an intraocular lensIOL Implantation at the 90 +/- 10 degrees axis |
| Axis 135 | Experimental | Device: Implantation of an intraocular lensIOL Implantation at the 135 +/- 10 degrees axis |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
- Need for spherical IOL correction between +0.00 and +32.00 D
- Pupil dilation of ≥ 7.0 mm
- Age 45 to 95
Key exclusion criteria (10 listed)
- Corneal abnormality (Corneal scaring)
- Preceding ocular surgery or trauma
- Uncontrolled glaucoma
- Proliferative diabetic retinopathy
- Iris neovascularization
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 |
|---|---|---|
| Implantation of an intraocular lensImplantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens. | Device | Axis 0, Axis 135, Axis 45, Axis 90 |
Primary outcome
Change of axial intraocular lens position
Time frame: 7 months
Change in axis position of an intraocular lens Zeiss 409 MP from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)
4 secondary outcomes
Decentration
Time frame: 7 months
Tilt
Time frame: 7 months
Anterior chamber depth
Time frame: 7 months
Best corrected visual acuity (BCVA)
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Intraocular Lens Rotation
Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
RecruitingObservational study
Intraocular Lens Implant Registry Study
Intraocular Lens Complication, Intraocular Lens Rotation
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.
Medical University of Vienna Allgemeines Krankenhaus
Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of an intraocular lens in people with Intraocular Lens Rotation and Capsular Tension Ring, 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 4 inclusion and 10 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 15 Apr 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of axial intraocular lens position (time frame: 7 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 15 Apr 2020.