CataractNCT02155478
Comparison of the Capsular Stability With Two Different IOL Models in Patients With Pseudoexfoliation Syndrome: an Exploratory Study
A study testing ISERT 250 (HOYA, Japan): a standard IOL and AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
The pseudoexfoliation (PXF syndrome) is caused by production and deposition of extracellular material in the anterior chamber of the eye as well as in other tissues of the body. Approx. 70 million worldwide have a PXF syndrome. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- ISERT 250 (HOYA, Japan): a standard IOL and AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2013to 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
- Pseudoexfoliation syndrome
- written informed consent prior to surgery
Who cannot join
- Relevant ophthalmic diseases that could affect corneal transparency or the ability for fixation of LEDs
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, State of Vienna, 1140
Oliver Findl, MD, MBA, +43 1 91021 ext. 84611, oliver@findl.at
Nino Hirnschall, MD
About this study
The pseudoexfoliation (PXF syndrome) is caused by production and deposition of extracellular material in the anterior chamber of the eye as well as in other tissues of the body. Approx. 70 million worldwide have a PXF syndrome.
After cataract surgery a decentration and subluxation of the intraocular lens (IOL) happens more frequently than in the general population due to a higher incidence of zonular weakness and an increased capsular fibrotic reaction.
Read more
Decentration, tilt and / or rotation of the lens can reduce the quality of vision.
It is believed that the design of the implanted IOL, more precisely the front surface of the IOL has an influence on the extent of capsular fibrosis and contraction. Especially in presence of capsular instability, as it is in patients with Pseudoexfoliation syndrome the design of the IOL has an effect on the post-operative stability.
In this study, two different IOL models are compared in terms of their stability. The "Tecnis 1-piece ZCB00" (AMO, USA), with a concave lowering comprising the lens edge and the "Acrysof SA60AT" (Alcon, USA), with a biconvex design are compared. Forty eyes of 20 patients are planned to be included in this study. One eye receives the "Tecnis ZCB00 1-piece "(AMO, USA), while the other eye receives the"Acrysof SA60AT "(Alcon, USA).
In which eye which IOL is implanted, is assigned by randomization. To measure the decentration, tilt and rotation of the IOL an examination will be performed before the operation and there will be follow-ups one hour after the operation of the first eye, one hour after the operation of the second eye, three months and twelve months after the operation on the second eye. All measurements will be done without touching the eye.
Read the detailed description
Pseudoexfoliation (PXF) is an age-related disease characterized by production of extracellular material in the anterior segment of the eye and other tissues of the body. While only 0.6% of people between 52 and 65 years are affected, 5% of people between 75 years and 85 years have Pseudoexfoliation syndrome. An estimated 70 million people may have PXF worldwide. PXF can be associated with glaucoma, cataract, reduced pupil dilatation, zonule weakness, and postoperative complications. After cataract surgery decentration and subluxation of the intra-ocular lens (IOL) is more likely in patients with Pseudoexfoliation syndrome due to the higher incidence of zonular weakness as well as the increased capsule fibrotic reaction. It has to be taken into account that an anterior chamber depth (ACD) shift, decentration, tilt or rotation of an IOL could result in a severe reduction in visual quality. For an aspherical IOL, for instance, it is essential not to be decentered and tilted more than 0.4 mm (0.8 mm 7) and 7° (10° 7), respectively. Otherwise it will be outperformed by a spherical IOL. We assume that the design of the IOL, more precisely the design of the anterior surface of the IOL, can influence the degree of capsule fibrosis and contraction, especially in patients who tend to have capsular instability like patients with PXF syndrome. The Tecnis 1-piece ZCB00 (AMO, California, USA), a single-piece hydrophobic acrylic open-loop IOL has its convex anterior surface not up to the edge of the IOL optic, but instead has a concave depression before reaching the edge. Due to this particular shape of the anterior surface, the anterior lens capsule typically only has contact at the IOL optic edge with the remaining central part up to the rhexis edge 'floating' over the optic without contact. Due to this situation, we expect less fibrotic reaction of the capsule because of a lack of contact between the lens epithelial cells of the anterior capsule not transdifferentiating into myofibroblasts and not laying down collagen that result in the typical contraction and whitening of the anterior capsule. On the contrary, another IOL, the ISERT 250 (HOYA, Japan), also a hydrophobic acrylic open-loop IOL, has an anterior surface which is convex all the way to the optic edge resulting in complete contact of the rhexis edge and overlying the anterior capsule on the IOL optic. This may aggravate the anterior lens capsule reaction to the IOL material which may result in more capsular contraction due to pronounced fibrosis of the capsule and in turn results in decentration and or tilt of the IOL.
Aim of this study is to assess the differences of IOL tilt and decentration in patients with pseudoexfoliation syndrome (PXF) with two different IOLs, the Tecnis 1-piece ZCB00, (AMO, USA) and the ISERT 250 (HOYA, Japan), measured with an AS-OCT, Scheimpflug imaging and Purkinjemeter.
- Conditions
- Cataract
- Being tested
- ISERT 250 (HOYA, Japan): a standard IOL, AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISERT 250 (HOYA, Japan): a standard IOLDevice
AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOLDevice
| Study group | Role | What they receive |
|---|---|---|
| AMO ZCB00 | Other | AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL Receives: Device: AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL |
| ISERT 250 | Active comparator | ISERT 250 (HOYA, Japan): a standard IOL Receives: Device: ISERT 250 (HOYA, Japan): a standard IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the two IOLS in postoperative IOL tilt (degrees) and decentration (mm) measured with the Purkinjemeter
Measured: 12 months
Secondary outcomes (5)
Horizontal and vertical IOL tilt (in °) evaluated from AS-OCT and Scheimpflug images
Measured: 12 months
Change in rhexis diameter (mm in retroillumination foto)
Measured: 12 months
Change in anterior chamber depth (in mm) measured with the AC Master
Measured: 12 months
Subjective evaluation of IOL - anterior capsule interconnection ( capsule overlapping the IOL optic edge in slitlamp examination)
Measured: 12 months
Change in aqueous flare measured with laser flare meter
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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, Principal investigator, ViROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155478
- Sponsor's protocol ID
- PXF
- Status last verified
- Jun 2014
- First submitted
- 2 Jun 2014
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Capsular Stability With Two Different IOL Models in Patients With Pseudoexfoliation Syndrome: an Exploratory Study
- ClinicalTrials.gov ID
- NCT02155478
- Acronym / sponsor ID
- PXF
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 4 Jun 2014 (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.
The pseudoexfoliation (PXF syndrome) is caused by production and deposition of extracellular material in the anterior chamber of the eye as well as in other tissues of the body. Approx. 70 million worldwide have a PXF syndrome.
After cataract surgery a decentration and subluxation of the intraocular lens (IOL) happens more frequently than in the general population due to a higher incidence of zonular weakness and an increased capsular fibrotic reaction.
Decentration, tilt and / or rotation of the lens can reduce the quality of vision.
It is believed that the design of the implanted IOL, more precisely the front surface of the IOL has an influence on the extent of capsular fibrosis and contraction. Especially in presence of capsular instability, as it is in patients with Pseudoexfoliation syndrome the design of the IOL has an effect on the post-operative stability.
In this study, two different IOL models are compared in terms of their stability. The "Tecnis 1-piece ZCB00" (AMO, USA), with a concave lowering comprising the lens edge and the "Acrysof SA60AT" (Alcon, USA), with a biconvex design are compared. Forty eyes of 20 patients are planned to be included in this study. One eye receives the "Tecnis ZCB00 1-piece "(AMO, USA), while the other eye receives the"Acrysof SA60AT "(Alcon, USA).
In which eye which IOL is implanted, is assigned by randomization. To measure the decentration, tilt and rotation of the IOL an examination will be performed before the operation and there will be follow-ups one hour after the operation of the first eye, one hour after the operation of the second eye, three months and twelve months after the operation on the second eye. All measurements will be done without touching the eye.
Detailed description
Pseudoexfoliation (PXF) is an age-related disease characterized by production of extracellular material in the anterior segment of the eye and other tissues of the body. While only 0.6% of people between 52 and 65 years are affected, 5% of people between 75 years and 85 years have Pseudoexfoliation syndrome. An estimated 70 million people may have PXF worldwide. PXF can be associated with glaucoma, cataract, reduced pupil dilatation, zonule weakness, and postoperative complications. After cataract surgery decentration and subluxation of the intra-ocular lens (IOL) is more likely in patients with Pseudoexfoliation syndrome due to the higher incidence of zonular weakness as well as the increased capsule fibrotic reaction. It has to be taken into account that an anterior chamber depth (ACD) shift, decentration, tilt or rotation of an IOL could result in a severe reduction in visual quality. For an aspherical IOL, for instance, it is essential not to be decentered and tilted more than 0.4 mm (0.8 mm 7) and 7° (10° 7), respectively. Otherwise it will be outperformed by a spherical IOL. We assume that the design of the IOL, more precisely the design of the anterior surface of the IOL, can influence the degree of capsule fibrosis and contraction, especially in patients who tend to have capsular instability like patients with PXF syndrome. The Tecnis 1-piece ZCB00 (AMO, California, USA), a single-piece hydrophobic acrylic open-loop IOL has its convex anterior surface not up to the edge of the IOL optic, but instead has a concave depression before reaching the edge. Due to this particular shape of the anterior surface, the anterior lens capsule typically only has contact at the IOL optic edge with the remaining central part up to the rhexis edge 'floating' over the optic without contact. Due to this situation, we expect less fibrotic reaction of the capsule because of a lack of contact between the lens epithelial cells of the anterior capsule not transdifferentiating into myofibroblasts and not laying down collagen that result in the typical contraction and whitening of the anterior capsule. On the contrary, another IOL, the ISERT 250 (HOYA, Japan), also a hydrophobic acrylic open-loop IOL, has an anterior surface which is convex all the way to the optic edge resulting in complete contact of the rhexis edge and overlying the anterior capsule on the IOL optic. This may aggravate the anterior lens capsule reaction to the IOL material which may result in more capsular contraction due to pronounced fibrosis of the capsule and in turn results in decentration and or tilt of the IOL.
Aim of this study is to assess the differences of IOL tilt and decentration in patients with pseudoexfoliation syndrome (PXF) with two different IOLs, the Tecnis 1-piece ZCB00, (AMO, USA) and the ISERT 250 (HOYA, Japan), measured with an AS-OCT, Scheimpflug imaging and Purkinjemeter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMO ZCB00 | Other | Device: AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOLAMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL |
| ISERT 250 | Active comparator | Device: ISERT 250 (HOYA, Japan): a standard IOLISERT 250 (HOYA, Japan): a standard IOL |
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
- Pseudoexfoliation syndrome
- written informed consent prior to surgery
Key exclusion criteria (2 listed)
- Relevant ophthalmic diseases that could affect corneal transparency or the ability for fixation of LEDs
- In case of pregnancy (pregnancy test will be taken preoperatively 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 |
|---|---|---|
| ISERT 250 (HOYA, Japan): a standard IOL | Device | ISERT 250 |
| AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL | Device | AMO ZCB00 |
Primary outcome
Difference between the two IOLS in postoperative IOL tilt (degrees) and decentration (mm) measured with the Purkinjemeter
Time frame: 12 months
5 secondary outcomes
Horizontal and vertical IOL tilt (in °) evaluated from AS-OCT and Scheimpflug images
Time frame: 12 months
Change in rhexis diameter (mm in retroillumination foto)
Time frame: 12 months
Change in anterior chamber depth (in mm) measured with the AC Master
Time frame: 12 months
Subjective evaluation of IOL - anterior capsule interconnection ( capsule overlapping the IOL optic edge in slitlamp examination)
Time frame: 12 months
Change in aqueous flare measured with laser flare meter
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
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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.
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, Austria
Oliver Findl principal investigator
ViROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISERT 250 (HOYA, Japan): a standard IOL and AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL 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 2 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 4 Jun 2014. 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?
Difference between the two IOLS in postoperative IOL tilt (degrees) and decentration (mm) measured with the Purkinjemeter (time frame: 12 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 4 Jun 2014.