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

Phase 4

Completed

• Conditions: Cataract; Diabetes; Pseudoexfoliation Syndrome
• Interventions: Device: Polylens EC-Y10-PAL (uncoated); Device: Polylens EC-HY10-PAL (coated)

• Registration Number: NCT01767012
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Status Verified: 2013-01
• Study First Submitted: 2013-01-06
• Study First Submitted QC: 2013-01-09
• Last Update Submitted: 2013-01-09
• Study First Posted: 2013-01-11
• Last Update Posted: 2013-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Preceding ocular surgery or trauma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polylens EC-Y10-PAL (uncoated)	Polylens EC-Y10-PAL (uncoated)	hydrophobic acrylic IOL (no coating) implantation during cataract surgery
Polylens EC-Y10H-PAL (coated)	Polylens EC-HY10-PAL (coated)	hydrophobic acrylic heparin-coated IOL implantation during cataract surgery

Primary Outcome Measures

Name	Time	Method
Amount of aqueous flare measured with a Laser flare meter	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.

Secondary Outcome Measures

Name	Time	Method
Anterior capsule opacification (measured as brightness of anterior capsular reflect on slitlamp photographs)	1 hour to 3 months postoperatively	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.

Trial Locations

Locations (1)

Hanusch-Krankenhaus; 🇦🇹 Vienna, Austria