Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties (POL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier:
NCT01767012
First received: January 6, 2013
Last updated: January 9, 2013
Last verified: January 2013

January 6, 2013
January 9, 2013
August 2010
August 2012   (final data collection date for primary outcome measure)
Amount of aqueous flare measured with a Laser flare meter [ Time Frame: 1 hour - 3 months postoperatively ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01767012 on ClinicalTrials.gov Archive Site
Anterior capsule opacification (measured as brightness of anterior capsular reflect on slitlamp photographs) [ Time Frame: 1 hour to 3 months postoperatively ] [ Designated as safety issue: No ]
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.
Same as current
  • IOL centration measured with a Purkinje-meter [ Time Frame: 3 months post-OP ] [ Designated as safety issue: No ]
    The amount of IOL decentration (mm) was measured with a Purkinje-meter system, which analyses misalignment of the optical surfaces of the eye due to position of Purkinje-reflexes.
  • IOL tilt measured with a Purkinje-meter [ Time Frame: 3 months postOP ] [ Designated as safety issue: No ]
    The amount of IOL tilt (°) was measured with a Purkinje-meter system, which analyses misalignment of the optical surfaces of the eye due to position of Purkinje-reflexes.
Same as current
 
Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties
Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cataract
  • Diabetes
  • Pseudoexfoliation Syndrome
  • Device: Polylens EC-HY10-PAL (coated)
    hydrophobic acrylic IOL with modified surface properties (Heparin-coating)
  • Device: Polylens EC-Y10-PAL (uncoated)
    Other Name: hydrophobic acrylic IOL
  • Active Comparator: Polylens EC-Y10-PAL (uncoated)
    hydrophobic acrylic IOL (no coating) implantation during cataract surgery
    Intervention: Device: Polylens EC-Y10-PAL (uncoated)
  • Active Comparator: Polylens EC-Y10H-PAL (coated)
    hydrophobic acrylic heparin-coated IOL implantation during cataract surgery
    Intervention: Device: Polylens EC-HY10-PAL (coated)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bilateral age-related cataract
  • Age 40 and older
  • Diabetes mellitus OR pseudoexfoliation syndrome

Exclusion Criteria:

  • Preceding ocular surgery or trauma
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01767012
Viros_POLYLENS
Not Provided
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
Vienna Institute for Research in Ocular Surgery
Not Provided
Not Provided
Vienna Institute for Research in Ocular Surgery
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP