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

Study Overview
=================
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.

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

Conditions
-----------------
Cataract, Diabetes, Pseudoexfoliation Syndrome

Intervention / Treatment
-----------------
* Device: Polylens EC-HY10-PAL (coated)
* Device: Polylens EC-Y10-PAL (uncoated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral age-related cataract Age 40 and older Diabetes mellitus OR pseudoexfoliation syndrome Exclusion Criteria: Preceding ocular surgery or trauma

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polylens EC-Y10-PAL (uncoated)<br>hydrophobic acrylic IOL (no coating) implantation during cataract surgery | Device: Polylens EC-Y10-PAL (uncoated)<br> <br> * Other names: hydrophobic acrylic IOL;|
| Active Comparator: Polylens EC-Y10H-PAL (coated)<br>hydrophobic acrylic heparin-coated IOL implantation during cataract surgery | Device: Polylens EC-HY10-PAL (coated)<br>* hydrophobic acrylic IOL with modified surface properties (Heparin-coating)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior capsule opacification (measured as brightness of anterior capsular reflect on slitlamp photographs) | 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. | 1 hour to 3 months postoperatively |