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临床试验/NCT01767012
NCT01767012已完成4 期

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

Vienna Institute for Research in Ocular Surgery2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年8月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Amount of aqueous flare measured with a Laser flare meter

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Preceding ocular surgery or trauma

结局指标

主要结局

Amount of aqueous flare measured with a Laser flare meter

时间窗: 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.

次要结局

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

研究者

发起方
Vienna Institute for Research in Ocular Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

MD, MBA

Vienna Institute for Research in Ocular Surgery

研究点 (2)

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