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
  Purpose

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.


Condition Intervention Phase
Cataract
Diabetes
Pseudoexfoliation Syndrome
Device: Polylens EC-HY10-PAL (coated)
Device: Polylens EC-Y10-PAL (uncoated)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties

Resource links provided by NLM:


Further study details as provided by Vienna Institute for Research in Ocular Surgery:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: August 2010
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Polylens EC-Y10-PAL (uncoated)
hydrophobic acrylic IOL (no coating) implantation during cataract surgery
Device: Polylens EC-Y10-PAL (uncoated)
Other Name: hydrophobic acrylic IOL
Active Comparator: Polylens EC-Y10H-PAL (coated)
hydrophobic acrylic heparin-coated IOL implantation during cataract surgery
Device: Polylens EC-HY10-PAL (coated)
hydrophobic acrylic IOL with modified surface properties (Heparin-coating)

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Preceding ocular surgery or trauma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767012

Locations
Austria
Hanusch-Krankenhaus
Vienna, Austria, A-1140
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
  More Information

No publications provided

Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, MD, MBA, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT01767012     History of Changes
Other Study ID Numbers: Viros_POLYLENS
Study First Received: January 6, 2013
Last Updated: January 9, 2013
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Cataract
Exfoliation Syndrome
Lens Diseases
Eye Diseases
Iris Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 26, 2014