Posterior Capsule OpacificationNCT03831074
Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses
A study testing Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G in people with Posterior Capsule Opacification, run by Medical University of Vienna.
Trial summary
The most frequent long-term complication of cataract surgery remains to be posterior capsule opacification (PCO). During the past decades many new intraocular lenses (IOL) with optimized lens material and design were introduced. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Posterior Capsule Opacification
- What is being tested?
- Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- 27 Jan 2012to 7 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
- Age 40 and older
- Visual potential in both eyes of 20/30 or better as determined by investigators estimation
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Who cannot join
- Preceding ocular surgery or trauma
- Relevant other ophthalmic diseases (such as pseudoexfoliation, retinal degenerations, etc.)
- Uncontrolled systemic or ocular disease
About this study
The most frequent long-term complication of cataract surgery remains to be posterior capsule opacification (PCO). During the past decades many new intraocular lenses (IOL) with optimized lens material and design were introduced. We propose a study comparing three acrylic single-piece IOLs with different design and hydrophobic material. All IOLs (Hoya NY-60, HOYA Surgical Optics GmbH; EyeCee One, Nidek Co., Aichi, Japan) are commercially available and are used for routine cataract surgery. In this study a comparison of PCO score of all two IOLs, a comparison of optic quality with wavefront analyses, visual acuity, contrast sensitivity, IOL decentration and tilt, slitlamp examination, fibrosis, glistening intensity (subjectively scored), YAG capsulotomy rate, and safety parameters (IOL related adverse reactions) of the investigated IOLs will be performed. Since PCO develops slowly within years, a long-term follow-up of three years will be necessary.
As those IOLs are currently often implanted IOLs, their performance on PCO development and their optical quality is of high interest for the ophthalmologic community.
- Conditions
- Posterior Capsule Opacification
- Being tested
- Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60GDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior capsule opacification
Posterior capsule opacification in the 2 IOLs will be assessed with semi automated quantification of cataract software
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start27 Jan 2012
- Primary completion7 Jul 2015
- Study completion7 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Capsule OpacificationStudies 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
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katharina Kriechbaum, Medical University of Vienna
- Investigators
- Katharina Kriechbaum, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831074
- Sponsor's protocol ID
- 933/2011
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses
- ClinicalTrials.gov ID
- NCT03831074
- Acronym / sponsor ID
- 933/2011
- Conditions
- Posterior Capsule Opacification
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 27 Jan 2012 (actual)
- Primary completion
- 7 Jul 2015 (actual)
- Study completion
- 7 Jul 2015 (actual)
- First posted
- 5 Feb 2019 (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 most frequent long-term complication of cataract surgery remains to be posterior capsule opacification (PCO). During the past decades many new intraocular lenses (IOL) with optimized lens material and design were introduced. We propose a study comparing three acrylic single-piece IOLs with different design and hydrophobic material. All IOLs (Hoya NY-60, HOYA Surgical Optics GmbH; EyeCee One, Nidek Co., Aichi, Japan) are commercially available and are used for routine cataract surgery. In this study a comparison of PCO score of all two IOLs, a comparison of optic quality with wavefront analyses, visual acuity, contrast sensitivity, IOL decentration and tilt, slitlamp examination, fibrosis, glistening intensity (subjectively scored), YAG capsulotomy rate, and safety parameters (IOL related adverse reactions) of the investigated IOLs will be performed. Since PCO develops slowly within years, a long-term follow-up of three years will be necessary.
As those IOLs are currently often implanted IOLs, their performance on PCO development and their optical quality is of high interest for the ophthalmologic community.
Study design
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
- Age 40 and older
- Visual potential in both eyes of 20/30 or better as determined by investigators estimation
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (3 listed)
- Preceding ocular surgery or trauma
- Relevant other ophthalmic diseases (such as pseudoexfoliation, retinal degenerations, etc.)
- Uncontrolled systemic or ocular disease
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 lenses: iMics 1 NY-60 & NY-60G | Device | – |
Primary outcome
Posterior capsule opacification
Time frame: 3 years
Posterior capsule opacification in the 2 IOLs will be assessed with semi automated quantification of cataract software
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 Feb 2019.
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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.
Katharina Kriechbaum principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G in people with Posterior Capsule Opacification, run by Medical University of Vienna.
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: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Posterior capsule opacification (time frame: 3 years). 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 Feb 2019.