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

NCT ID: NCT01767012

Last Updated: 2013-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-11-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Polylens EC-Y10-PAL (uncoated)

hydrophobic acrylic IOL (no coating) implantation during cataract surgery

Group Type: ACTIVE_COMPARATOR

Polylens EC-Y10-PAL (uncoated)

Intervention Type: DEVICE

Polylens EC-Y10H-PAL (coated)

hydrophobic acrylic heparin-coated IOL implantation during cataract surgery

Group Type: ACTIVE_COMPARATOR

Polylens EC-HY10-PAL (coated)

Intervention Type: DEVICE

hydrophobic acrylic IOL with modified surface properties (Heparin-coating)

Interventions

Polylens EC-HY10-PAL (coated)

hydrophobic acrylic IOL with modified surface properties (Heparin-coating)

Intervention Type: DEVICE

Polylens EC-Y10-PAL (uncoated)

Intervention Type: DEVICE

Other Intervention Names

hydrophobic acrylic IOL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Preceding ocular surgery or trauma

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

MD, MBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hanusch-Krankenhaus

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

Viros_POLYLENS

Identifier Type: -

Identifier Source: org_study_id