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临床试验/NCT02412215
NCT02412215Unknown不适用

Rotational Stability After Nanoflex Collamer Toric Intraocular Lens Implantation in Astigmatic Patients Undergoing Cataract Surgery

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Change in rotational stability of the toric intraocular lens (T-IOL).

研究概览

简要总结

This study aims to assess the rotational stability of the new collameric Nanoflex toric intraocular lens (T-IOL) by STAAR inserted in astigmatic patients after cataract surgery.

The purpose of this study is also to determine whether the use of a toric intraocular lens (T-IOL) improves visual acuity.

详细描述

A good rotational stability of toric intraocular lenses (T-IOL) allows an accurate refractive correction. However, many aspects -both pre-operative and post-operative- can interfere causing T-IOL rotation and misalignment.

Complete preoperative ocular evaluation is performed including slit-lamp examination, uncorrected distance visual acuity (UDVA), best-corrected visual acuity (BCVA), Javal keratometry, corneal Scheimplug tomography (Pentacam), optical biometry (IOL Master), Goldman applanation tonometry and fundus evaluation through dilated pupils. The spherical IOL power is calculated considering the axial length obtained with optical biometry, the magnitude of astigmatism derived from Javal keratometry and the steepest axis obtained with corneal tomography. The power of the toric IOL is determined with the online Staar Toric IOL calculator. The reference landmarks are also marked preoperatively with a sterile methylene blue fine point pen. The marking is rechecked in the operating theatre with the electronic toric marker ASICO.

Postoperative evaluation for IOL alignment and rotational stability is performed with slit-lamp photography on dilated pupils. Images are captured with Haag Streit slit lamp BQ 900 and are evaluated with the image-analysis software Protractor (Staar).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

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

入选标准

  • Patients of 60 years of age ore more
  • Corneal astigmatism of 1 diopter (D) or more

排除标准

  • Primary or secondary pathological conditions of the cornea
  • Zonular fibres pathologies (phacodonesis, pseudoexfoliation syndrome)
  • Irregular astigmatism (corneal scar, keratoconus, pterygium)
  • Traumatic cataract
  • Previous ocular surgery
  • Complications during cataract surgery

结局指标

主要结局

Change in rotational stability of the toric intraocular lens (T-IOL).

时间窗: Change of rotational stability at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery.

The misalignment of the lens is defined as the difference (Δ) between the intended axis and the actual axis of the new collameric Nanoflex T-IOL by STAAR.

次要结局

  • Correction of the astigmatism.(Change in visual acuity at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months and 18 months after surgery)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Fea

Antonio Fea MD. PhD

University of Turin, Italy

研究点 (2)

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