Posterior Capsule OpacificationMIPHYNCT01734343
Posterior Capsule Opacification Development With Two Different Intraocular Lenses
A study testing HOYA iMics Y-60H and PhysIOL microAY 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 PhysIOL microAY
- 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
- Jan 2009to Jun 2012
- 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
Official title: Posterior Capsule Opacification Development and Frequency of Nd:YAG Treatment of Two Microincision IOLs: Hoya iMics Y-60H vs. PhysIOL microAY
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 3 years.
- Conditions
- Posterior Capsule Opacification, Cataract
- Being tested
- HOYA iMics Y-60H, PhysIOL microAY
- 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
PhysIOL microAYDevice
same-day bilateral cataract surgery with implantation of intraocular lens PhysIOL microAY 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 |
| PhysIOL microAY | Other | eyes with implanted intraocular lens PhysIOL microAY Receives: Device: PhysIOL microAY |
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: 3 years
Secondary outcomes (2)
best corrected visual acuity (BCVA)
Measured: 3 years
Nd:YAG rate
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 posted27 Nov 2012 (estimated)
- Study startJan 2009
- Primary completionMay 2012
- Study completionJun 2012
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
- 65 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
- Investigators
- Rupert Menapace, Prof. Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734343
- Sponsor's protocol ID
- EK Nr:847/2010
- Acronym
- MIPHY
- Status last verified
- Nov 2012
- First submitted
- 22 Nov 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Capsule Opacification Development and Frequency of Nd:YAG Treatment of Two Microincision IOLs: Hoya iMics Y-60H vs. PhysIOL microAY
- ClinicalTrials.gov ID
- NCT01734343
- Acronym / sponsor ID
- MIPHY / EK Nr:847/2010
- Conditions
- Posterior Capsule Opacification, Cataract
- Keywords
- posterior capsule opacification, PCO, after cataract, intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Nov 2012 (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 3 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 |
| PhysIOL microAY | Other | Device: PhysIOL microAYeyes with implanted intraocular lens PhysIOL microAY |
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 |
| PhysIOL microAYsame-day bilateral cataract surgery with implantation of intraocular lens PhysIOL microAY in one eye | Device | PhysIOL microAY |
Primary outcome
posterior capsular opacification (PCO)
Time frame: 3 years
subjective and objective PCO scoring
2 secondary outcomes
best corrected visual acuity (BCVA)
Time frame: 3 years
Nd:YAG rate
Time frame: 3 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 27 Nov 2012.
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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.
Rupert Menapace, Prof. Dr. principal investigator
Medical University of Vienna
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 PhysIOL microAY 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 27 Nov 2012. 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: 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 27 Nov 2012.