CataractPhase 4POLNCT01767012
Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties
A Phase 4 study testing Polylens EC-HY10-PAL (coated) and Polylens EC-Y10-PAL (uncoated) in people with Cataract and Diabetes, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Modern phacoemulsification techniques have made cataract surgery safe and efficient over the past several decades. Although the phacoemulsification procedure has improved greatly, cataract surgery still involves trauma. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract, Diabetes, Pseudoexfoliation Syndrome
- What is being tested?
- Polylens EC-HY10-PAL (coated) and Polylens EC-Y10-PAL (uncoated)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2010to Nov 2012
- Phase
- Phase 4
- 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
- Bilateral age-related cataract
- Age 40 and older
- Diabetes mellitus OR pseudoexfoliation syndrome
Who cannot join
- Preceding ocular surgery or trauma
Trial locations and contacts
1 site in 1 country.
About this study
Modern phacoemulsification techniques have made cataract surgery safe and efficient over the past several decades. Although the phacoemulsification procedure has improved greatly, cataract surgery still involves trauma. One of the surgical traumas during cataract surgery is the direct trauma of the anterior uvea, resulting in a later chronic immune reaction of the uvea to the implanted intraocular lens (IOL). 1 The breakdown of the blood-aqueous barrier (a measure of the uveal reaction) clinically presents as flare in the anterior chamber. 2 Petternel et al. 3 explained that the protein content of the aqueous humor may mainly arise from the iris root and iris vessels in the anterior chamber. The peak of this flare and cell intensity in the anterior chamber was shown to be reached during the first two days after cataract surgery 4 and flare levels were back to the preoperative values about one year after cataract surgery. 5, 6 Influencing factors are surgical technique 7, perioperative treatment 8, IOL biomaterial and design 9 and host reaction to the IOL.
In this study the otherwise same IOL concerning material and design, but one with a new surface modification will be compared to assess the influence on aqueous flare and cell intensity in the anterior chamber. The Polylens (Polytech, Rossdorf, Germany) is a hydrophobic acrylic single-piece open-loop IOL and is available with the standard surface and a novel modified surface.
To assess the efficacy of the newly modified surface of the Polylens IOL compared to the same IOL without a modified surface concerning flare and cell intensity in the anterior chamber as well as cellular components on the IOL surface and lens epithelial out-growth from the rhexis after cataract surgery in eyes of patients with diabetes mellitus and pseudoexfoliation syndrome, which typically have a higher incidence of post-operative intra-ocular inflammation.
- Conditions
- Cataract, Diabetes, Pseudoexfoliation Syndrome
- Being tested
- Polylens EC-HY10-PAL (coated), Polylens EC-Y10-PAL (uncoated)
- Medical subject headings
- Cataract, Diabetes Mellitus, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polylens EC-HY10-PAL (coated)Device
hydrophobic acrylic IOL with modified surface properties (Heparin-coating)
Polylens EC-Y10-PAL (uncoated)Device
Also called hydrophobic acrylic IOL
| Study group | Role | What they receive |
|---|---|---|
| Polylens EC-Y10-PAL (uncoated) | Active comparator | hydrophobic acrylic IOL (no coating) implantation during cataract surgery Receives: Device: Polylens EC-Y10-PAL (uncoated) |
| Polylens EC-Y10H-PAL (coated) | Active comparator | hydrophobic acrylic heparin-coated IOL implantation during cataract surgery Receives: Device: Polylens EC-HY10-PAL (coated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of aqueous flare measured with a Laser flare meter
The amount of aqueous flare was measured with a Laser flare meter (Kowa FM-600, Kowa Optimed, USA).The unit of measurement is photon counts per millisecond (pc/ms). The higher flare values, the higher the intracameral amount of protein and, therefore, the higher the intraocular inflammatory response.
Measured: 1 hour - 3 months postoperatively
Secondary outcomes (1)
Anterior capsule opacification (measured as brightness of anterior capsular reflect on slitlamp photographs)
Objective ACO evaluation was obtained after taking 2 slit lamp images in a standardised way of each eye: the area of the anterior capsule in contact with the IOL was defined as the area of interest. Part of the dark area not directly illuminated by the slit beam within the capsulorhexis served as the control area. The difference in brightness between the area of interest and the control area defined the grade of fibrosis in per cent, with 0% representing a clear anterior capsule and 100%, a completely white anterior capsule.
Measured: 1 hour to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startAug 2010
- Primary completionAug 2012
- Study completionNov 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767012
- Sponsor's protocol ID
- Viros_POLYLENS
- Acronym
- POL
- Status last verified
- Jan 2013
- First submitted
- 6 Jan 2013
- Last updated
- 11 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties
- ClinicalTrials.gov ID
- NCT01767012
- Acronym / sponsor ID
- POL / Viros_POLYLENS
- Conditions
- Cataract, Diabetes, Pseudoexfoliation Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Jan 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.
Modern phacoemulsification techniques have made cataract surgery safe and efficient over the past several decades. Although the phacoemulsification procedure has improved greatly, cataract surgery still involves trauma. One of the surgical traumas during cataract surgery is the direct trauma of the anterior uvea, resulting in a later chronic immune reaction of the uvea to the implanted intraocular lens (IOL). 1 The breakdown of the blood-aqueous barrier (a measure of the uveal reaction) clinically presents as flare in the anterior chamber. 2 Petternel et al. 3 explained that the protein content of the aqueous humor may mainly arise from the iris root and iris vessels in the anterior chamber. The peak of this flare and cell intensity in the anterior chamber was shown to be reached during the first two days after cataract surgery 4 and flare levels were back to the preoperative values about one year after cataract surgery. 5, 6 Influencing factors are surgical technique 7, perioperative treatment 8, IOL biomaterial and design 9 and host reaction to the IOL.
In this study the otherwise same IOL concerning material and design, but one with a new surface modification will be compared to assess the influence on aqueous flare and cell intensity in the anterior chamber. The Polylens (Polytech, Rossdorf, Germany) is a hydrophobic acrylic single-piece open-loop IOL and is available with the standard surface and a novel modified surface.
To assess the efficacy of the newly modified surface of the Polylens IOL compared to the same IOL without a modified surface concerning flare and cell intensity in the anterior chamber as well as cellular components on the IOL surface and lens epithelial out-growth from the rhexis after cataract surgery in eyes of patients with diabetes mellitus and pseudoexfoliation syndrome, which typically have a higher incidence of post-operative intra-ocular inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polylens EC-Y10-PAL (uncoated) | Active comparator | Device: Polylens EC-Y10-PAL (uncoated)hydrophobic acrylic IOL (no coating) implantation during cataract surgery |
| Polylens EC-Y10H-PAL (coated) | Active comparator | Device: Polylens EC-HY10-PAL (coated)hydrophobic acrylic heparin-coated IOL implantation during cataract surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bilateral age-related cataract
- Age 40 and older
- Diabetes mellitus OR pseudoexfoliation syndrome
Key exclusion criteria (1 listed)
- Preceding ocular surgery or trauma
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 |
|---|---|---|
| Polylens EC-HY10-PAL (coated)hydrophobic acrylic IOL with modified surface properties (Heparin-coating) | Device | Polylens EC-Y10H-PAL (coated) |
| Polylens EC-Y10-PAL (uncoated)Also: hydrophobic acrylic IOL | Device | Polylens EC-Y10-PAL (uncoated) |
Primary outcome
Amount of aqueous flare measured with a Laser flare meter
Time frame: 1 hour - 3 months postoperatively
The amount of aqueous flare was measured with a Laser flare meter (Kowa FM-600, Kowa Optimed, USA).The unit of measurement is photon counts per millisecond (pc/ms). The higher flare values, the higher the intracameral amount of protein and, therefore, the higher the intraocular inflammatory response.
1 secondary outcome
Anterior capsule opacification (measured as brightness of anterior capsular reflect on slitlamp photographs)
Time frame: 1 hour to 3 months postoperatively
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 11 Jan 2013.
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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.
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 Phase 4 study testing Polylens EC-HY10-PAL (coated) and Polylens EC-Y10-PAL (uncoated) in people with Cataract and Diabetes, 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 3 inclusion and 1 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 11 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Amount of aqueous flare measured with a Laser flare meter (time frame: 1 hour - 3 months postoperatively). 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 11 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.