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临床试验/NCT05053620
NCT05053620已完成不适用

Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)

OFTALVIST (Oftalmología Vistahermosa S.L)1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Response to treatment

研究概览

简要总结

This is an observational, prospective follow-up post-marketing study of CE marked medical devices aimed at treating astigmatism in patients with cataracts. The main objective is to evaluate the response of the intrastromal arcuate incisions procedure for the correction of low corneal astigmatism with the Catalys femtosecond laser using the Cassini Ambient equipment with iris registration in cataract surgery.

详细描述

All patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson & Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson & Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice.

A preoperative and postoperative evaluation will be carried out one month and four months after the intervention where the following tests will be performed: refraction, corneal topography with the Cassini Ambient equipment (Cassini Technologies, The Netherlands, with CE marking), measurement of visual acuity with and without correction, slit lamp examination and ocular biometry using the IOLMaster 700 non-contact optical biometer (Carl Zeiss, Germany, CE marked).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients who are going to undergo cataract surgery.
  • Low corneal astigmatism, between 0.50D and 1.25D.

排除标准

  • Previous corneal surgery.
  • Keratoconus.
  • Corneal scars

结局指标

主要结局

Response to treatment

时间窗: 4 months after the procedure

Evaluation of the response to the procedure

次要结局

  • Examination of the arcuate incisions(4 months after the procedure)
  • Evaluation of the visual acuity(4 months after the procedure)

研究者

发起方
OFTALVIST (Oftalmología Vistahermosa S.L)
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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