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

Primary Purpose

Cataract, Diabetes, Pseudoexfoliation Syndrome

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Polylens EC-HY10-PAL (coated)
Polylens EC-Y10-PAL (uncoated)
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Preceding ocular surgery or trauma

Sites / Locations

  • Hanusch-Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Polylens EC-Y10-PAL (uncoated)

Polylens EC-Y10H-PAL (coated)

Arm Description

hydrophobic acrylic IOL (no coating) implantation during cataract surgery

hydrophobic acrylic heparin-coated IOL implantation during cataract surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 6, 2013
Last Updated
January 9, 2013
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT01767012
Brief Title
Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties
Acronym
POL
Official Title
Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Diabetes, Pseudoexfoliation Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polylens EC-Y10-PAL (uncoated)
Arm Type
Active Comparator
Arm Description
hydrophobic acrylic IOL (no coating) implantation during cataract surgery
Arm Title
Polylens EC-Y10H-PAL (coated)
Arm Type
Active Comparator
Arm Description
hydrophobic acrylic heparin-coated IOL implantation during cataract surgery
Intervention Type
Device
Intervention Name(s)
Polylens EC-HY10-PAL (coated)
Intervention Description
hydrophobic acrylic IOL with modified surface properties (Heparin-coating)
Intervention Type
Device
Intervention Name(s)
Polylens EC-Y10-PAL (uncoated)
Other Intervention Name(s)
hydrophobic acrylic IOL
Primary Outcome Measure Information:
Title
Amount of aqueous flare measured with a Laser flare meter
Description
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.
Time Frame
1 hour - 3 months postoperatively
Secondary Outcome Measure Information:
Title
Anterior capsule opacification (measured as brightness of anterior capsular reflect on slitlamp photographs)
Description
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.
Time Frame
1 hour to 3 months postoperatively
Other Pre-specified Outcome Measures:
Title
IOL centration measured with a Purkinje-meter
Description
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.
Time Frame
3 months post-OP
Title
IOL tilt measured with a Purkinje-meter
Description
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.
Time Frame
3 months postOP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Bilateral age-related cataract Age 40 and older Diabetes mellitus OR pseudoexfoliation syndrome Exclusion Criteria: Preceding ocular surgery or trauma
Facility Information:
Facility Name
Hanusch-Krankenhaus
City
Vienna
ZIP/Postal Code
A-1140
Country
Austria

12. IPD Sharing Statement

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

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