Clinical trial NCT01767012: Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties
Official title: Aqueous Flare of a Hydrophobic Acrylic Single-piece Open-loop IOL With Modified Material Surface Properties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Diabetes
Pseudoexfoliation Syndrome
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Preceding ocular surgery or trauma

Primary outcomes:
measure: Amount of aqueous flare measured with a Laser flare meter
timeFrame: 1 hour - 3 months postoperatively
Secondary outcomes:
measure: Anterior capsule opacification (measured as brightness of anterior capsular reflect on slitlamp photographs)
timeFrame: 1 hour to 3 months postoperatively
Other outcomes:
measure: IOL centration measured with a Purkinje-meter
timeFrame: 3 months post-OP
measure: IOL tilt measured with a Purkinje-meter
timeFrame: 3 months postOP
Locations:
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus
Study officials:
References: