Posterior Capsule OpacificationNCT01786356
Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two IOLs: Hoya iMics Y-60H vs. Bausch&Lomb MI60 (MIMI)
A study testing HOYA iMics Y-60H and B&L MI60 in people with Posterior Capsule Opacification and Cataract, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Age-related cataract is the main cause of impaired vision in the elderly population worldwide. The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Posterior Capsule Opacification, Cataract
- What is being tested?
- HOYA iMics Y-60H and B&L MI60
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2008to Jan 2013
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral age-related cataract
- good overall physical constitution
Who cannot join
- previous intraocular surgery or ocular trauma
- intraocular complication like posterior capsular tear
- glaucoma
- uveitis
- corneal diseases, diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
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
Age-related cataract is the main cause of impaired vision in the elderly population worldwide.
The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.
Read more
The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.
Modifications in IOL design and material lead to a decrease in the incidence of PCO.
During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.
The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 4 years.
- Conditions
- Posterior Capsule Opacification, Cataract
- Being tested
- HOYA iMics Y-60H, B&L MI60
- Keywords
- posterior capsule opacification, PCO, after cataract, intraocular lens
- Medical subject headings
- Cataract, Capsule Opacification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOYA iMics Y-60HDevice
same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye
B&L MI60Other
same-day bilateral cataract surgery with implantation of intraocular lens B\&L MI60 in one eye
| Study group | Role | What they receive |
|---|---|---|
| HOYA iMics Y-60H | Other | eyes with implanted intraocular lens HOYA iMics Y-60H Receives: Device: HOYA iMics Y-60H |
| B&L MI60 | Other | eyes with implanted intraocular lens B\&L MI60 Receives: Other: B&L MI60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
posterior capsular opacification (PCO)
subjective and objective PCO scoring
Measured: 4 years
Secondary outcomes (2)
best corrected visual acuity (BCVA)
Measured: 4 years
Nd:YAG rate
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startMar 2008
- Primary completionDec 2012
- Study completionJan 2013
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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
- NCT01786356
- Sponsor's protocol ID
- EK Nr: 931/2010
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two IOLs: Hoya iMics Y-60H vs. Bausch&Lomb MI60 (MIMI)
- ClinicalTrials.gov ID
- NCT01786356
- Acronym / sponsor ID
- EK Nr: 931/2010
- Conditions
- Posterior Capsule Opacification, Cataract
- Keywords
- posterior capsule opacification, PCO, after cataract, intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Feb 2013 (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.
Age-related cataract is the main cause of impaired vision in the elderly population worldwide.
The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.
The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.
Modifications in IOL design and material lead to a decrease in the incidence of PCO.
During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.
The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 4 years.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOYA iMics Y-60H | Other | Device: HOYA iMics Y-60Heyes with implanted intraocular lens HOYA iMics Y-60H |
| B&L MI60 | Other | Other: B&L MI60eyes with implanted intraocular lens B\&L MI60 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- bilateral age-related cataract
- good overall physical constitution
Key exclusion criteria (5 listed)
- previous intraocular surgery or ocular trauma
- intraocular complication like posterior capsular tear
- glaucoma
- uveitis
- corneal diseases, diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
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 |
|---|---|---|
| HOYA iMics Y-60Hsame-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye | Device | HOYA iMics Y-60H |
| B&L MI60same-day bilateral cataract surgery with implantation of intraocular lens B\&L MI60 in one eye | Other | B&L MI60 |
Primary outcome
posterior capsular opacification (PCO)
Time frame: 4 years
subjective and objective PCO scoring
2 secondary outcomes
best corrected visual acuity (BCVA)
Time frame: 4 years
Nd:YAG rate
Time frame: 4 years
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 7 Feb 2013.
Related trials for Posterior Capsule Opacification
RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Dysphotopsia, Posterior Capsule Opacification
Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
RecruitingObservational study
IC-8 Apthera IOL New Enrollment Post Approval Study
Cataract, Presbyopia
Active, not recruiting
Role of Metformin in Posterior Capsule Opacification
Cataract, Diabetes Mellitus Type 2
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 HOYA iMics Y-60H and B&L MI60 in people with Posterior Capsule Opacification and 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 2 inclusion and 5 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 7 Feb 2013. 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?
posterior capsular opacification (PCO) (time frame: 4 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 7 Feb 2013.