CataractNCT04329754
Safety and Efficacy of a Novel Hydrophobic Acrylic IOL - iPure: a Randomised Study
A study testing Cataract surgery in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
In this study the rotational stability and performance - with respect to glistening and PCO formation - of a new hydrophobic acrylic IOL (IPure, PhysIOL, Belgium) will be compared to a gold standard IOL (AMO ZCB00) in a randomized controlled fashion. Fifty eyes of 50 patients will be included. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2012to Feb 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related cataract
- Age 21 and older
- Visual Acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
Who cannot join
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies
- Previous ocular surgery or trauma.
- Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140
About this study
In this study the rotational stability and performance - with respect to glistening and PCO formation - of a new hydrophobic acrylic IOL (IPure, PhysIOL, Belgium) will be compared to a gold standard IOL (AMO ZCB00) in a randomized controlled fashion. Fifty eyes of 50 patients will be included. 25 patients will receive the iPure and 25 patients will receive the standard IOL. Study hypothesis: The iPure IOL shows better rotational stability compared to the standard IOL. A clinically relevant difference for rotational stability is defined as 2°.
Read the detailed description
Although there may be no direct benefit to the subjects under study, the investigation will assess the stability which determines the efficacy for future toric optics and the amount of glistening and PCO formation of the IPure and ZCB00 hydrophobic acrylic IOLs.
25 eyes of 25 patients will be recruited for each IOL, that is 50 eyes of 50 patients. The randomization will be done with a binomial law. The IOL have a priori the same IOL constants which eliminates the necessity to know which IOL is going to be implanted at the preoperative time. A clinically relevant difference for rotational stability will be 2°. The reasonable standard deviation of the position of an IOL in the eye is 2.4°. A total of 48 patients is necessary for a probability of 80% to measure a clinically relevant difference concerning the IOL stability.
In the week before surgery, the eye to be operated is examined at the slit-lamp and by indirect fundoscopy and measurement of intraocular pressure (IOP) will be performed routinely. Additionally, routine biometry is performed using the IOLMaster (Zeiss Meditec AG, Jena, Germany) for axial length measurement, K-readings and anterior chamber depth (ACD) measurements.
Randomisation will be performed using online randomisation and patients will be allocated 1:1 either to the study group (iPure group), or to the control group (ZCB00).
A self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed in a standardised fashion. The IOL is implanted via injector into the capsular bag. Following the implantation of the IOL, the viscoelastic substance is aspirated thoroughly from the anterior chamber, as well as retro-lentally, to assure complete removal of the OVD.
Any deviation from the standard protocol will be recorded peroperatively. Follow-ups will be performed 1-2 hours, 1 month, 12 months and 24 months after cataract surgery.
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryDevice
Cataract surgery with implantation of an intraocular lens (IOL)
| Study group | Role | What they receive |
|---|---|---|
| iPure | Other | A new single-piece hydrophobic acrylic IOL (IPure IOL). The study IOL is a one-piece aspheric acrylic hydrophobic glistening-free lens, with a 4.9% water content, a 360 square posterior edge design, and a 5 haptic angulation, providing UV and blue-light filtration.
Patient were allocated into two groups. The study group received the iPure lens while the control group received Tecnis ZCB00. Randomisation was done with a binomial law, using random.org. The surgeon was masked to IOL allocation until shortly before implantation. Examiners were masked to IOL allocation. Receives: Device: Cataract surgery |
| ZCB00 | Other | A standard IOL (ZCB00).The control IOL, is a one-piece hydrophobic acrylic IOL with a biconvex aspheric optic and 360 continuous square posterior optic edge with a UV filter and an offset, stepped haptic design.
Patient were allocated into two groups. The study group received the iPure lens while the control group received Tecnis ZCB00. Randomisation was done with a binomial law, using random.org. The surgeon was masked to IOL allocation until shortly before implantation. Examiners were masked to IOL allocation. Receives: Device: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational Stability
measured using the Purkinje meter (Murcia University) and retroillumination images (degrees of rotation)
Measured: 2 years
Secondary outcomes (7)
Glistening
subjective measurement (0 to 4, 0 no glistening, 4 sever glistening)
Measured: 2 years
visual acuity
assessed by ETDRS charts at 4m
Measured: 2 years
PCO
scored with AQUA (0 to 10, 0 no PCO, 10 sever PCO) and the number of Nd:YAG capsulotomies
Measured: 2 years
Decentration in mm
measured by Purkinjemeter
Measured: 2 years
Tilt in degrees
measured by Purkinjemeter
Measured: 2 years
Capsulorhexis area
assessed by retroillumination images
Measured: 2 years
Anterior chamber depth
assessed by AC Master (in mm)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study startApr 2012
- Primary completionFeb 2015
- Study completionFeb 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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, MBA, Principal investigator, VIROS, Hanusch Hospital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329754
- Sponsor's protocol ID
- Viros_iPure
- Status last verified
- Oct 2022
- First submitted
- 25 Jan 2013
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Novel Hydrophobic Acrylic IOL - iPure: a Randomised Study
- ClinicalTrials.gov ID
- NCT04329754
- Acronym / sponsor ID
- Viros_iPure
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Apr 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.
In this study the rotational stability and performance - with respect to glistening and PCO formation - of a new hydrophobic acrylic IOL (IPure, PhysIOL, Belgium) will be compared to a gold standard IOL (AMO ZCB00) in a randomized controlled fashion. Fifty eyes of 50 patients will be included. 25 patients will receive the iPure and 25 patients will receive the standard IOL. Study hypothesis: The iPure IOL shows better rotational stability compared to the standard IOL. A clinically relevant difference for rotational stability is defined as 2°.
Detailed description
Although there may be no direct benefit to the subjects under study, the investigation will assess the stability which determines the efficacy for future toric optics and the amount of glistening and PCO formation of the IPure and ZCB00 hydrophobic acrylic IOLs.
25 eyes of 25 patients will be recruited for each IOL, that is 50 eyes of 50 patients. The randomization will be done with a binomial law. The IOL have a priori the same IOL constants which eliminates the necessity to know which IOL is going to be implanted at the preoperative time. A clinically relevant difference for rotational stability will be 2°. The reasonable standard deviation of the position of an IOL in the eye is 2.4°. A total of 48 patients is necessary for a probability of 80% to measure a clinically relevant difference concerning the IOL stability.
In the week before surgery, the eye to be operated is examined at the slit-lamp and by indirect fundoscopy and measurement of intraocular pressure (IOP) will be performed routinely. Additionally, routine biometry is performed using the IOLMaster (Zeiss Meditec AG, Jena, Germany) for axial length measurement, K-readings and anterior chamber depth (ACD) measurements.
Randomisation will be performed using online randomisation and patients will be allocated 1:1 either to the study group (iPure group), or to the control group (ZCB00).
A self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed in a standardised fashion. The IOL is implanted via injector into the capsular bag. Following the implantation of the IOL, the viscoelastic substance is aspirated thoroughly from the anterior chamber, as well as retro-lentally, to assure complete removal of the OVD.
Any deviation from the standard protocol will be recorded peroperatively. Follow-ups will be performed 1-2 hours, 1 month, 12 months and 24 months after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iPure | Other | Device: Cataract surgeryA new single-piece hydrophobic acrylic IOL (IPure IOL). The study IOL is a one-piece aspheric acrylic hydrophobic glistening-free lens, with a 4.9% water content, a 360 square posterior edge design, and a 5 haptic angulation, providing UV and blue-light filtration. Patient were allocated into two groups. The study group received the iPure lens while the control group received Tecnis ZCB00. Randomisation was done with a binomial law, using random.org. The surgeon was masked to IOL allocation until shortly before implantation. Examiners were masked to IOL allocation. |
| ZCB00 | Other | Device: Cataract surgeryA standard IOL (ZCB00).The control IOL, is a one-piece hydrophobic acrylic IOL with a biconvex aspheric optic and 360 continuous square posterior optic edge with a UV filter and an offset, stepped haptic design. Patient were allocated into two groups. The study group received the iPure lens while the control group received Tecnis ZCB00. Randomisation was done with a binomial law, using random.org. The surgeon was masked to IOL allocation until shortly before implantation. Examiners were masked to IOL allocation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age-related cataract
- Age 21 and older
- Visual Acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
Key exclusion criteria (3 listed)
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies
- Previous ocular surgery or trauma.
- Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
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 surgeryCataract surgery with implantation of an intraocular lens (IOL) | Device | ZCB00, iPure |
Primary outcome
Rotational Stability
Time frame: 2 years
measured using the Purkinje meter (Murcia University) and retroillumination images (degrees of rotation)
7 secondary outcomes
Glistening
Time frame: 2 years
visual acuity
Time frame: 2 years
PCO
Time frame: 2 years
Decentration in mm
Time frame: 2 years
Tilt in degrees
Time frame: 2 years
Capsulorhexis area
Time frame: 2 years
Anterior chamber depth
Time frame: 2 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 17 Oct 2022.
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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.
Oliver Findl, MD, MBA principal investigator
VIROS, Hanusch Hospital 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 Cataract surgery in people with Cataract, run by Vienna Institute for Research in Ocular Surgery 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 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 17 Oct 2022. 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?
Rotational Stability (time frame: 2 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 17 Oct 2022.