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

NCT01767012 | Completed Phase 4

• 1 other identifier: Viros_POLYLENS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour - 3 months postoperatively

Secondary Outcomes (1)

• Anterior capsule opacification (measured as brightness of anterior capsular reflect on slitlamp photographs)

  1 hour to 3 months postoperatively

Other Outcomes (2)

• IOL centration measured with a Purkinje-meter

  3 months post-OP

• IOL tilt measured with a Purkinje-meter

  3 months postOP

Study Arms (2)

Polylens EC-Y10-PAL (uncoated)

ACTIVE COMPARATOR

hydrophobic acrylic IOL (no coating) implantation during cataract surgery

Device: Polylens EC-Y10-PAL (uncoated)

Polylens EC-Y10H-PAL (coated)

ACTIVE COMPARATOR

hydrophobic acrylic heparin-coated IOL implantation during cataract surgery

Device: Polylens EC-HY10-PAL (coated)

Interventions

Polylens EC-HY10-PAL (coated) DEVICE

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

Polylens EC-Y10H-PAL (coated)

Polylens EC-Y10-PAL (uncoated) DEVICE

Also known as: hydrophobic acrylic IOL

Polylens EC-Y10-PAL (uncoated)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Preceding ocular surgery or trauma

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Hanusch-Krankenhaus

Vienna, Vienna, A-1140, Austria

Location

MeSH Terms

Conditions

Cataract; Diabetes Mellitus; Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Iris Diseases; Uveal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MBA

Study Record Dates

• First Submitted: January 6, 2013
• First Posted: January 11, 2013
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

AU (1)