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

NCT05053620 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2023-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Cataract
  • Astigmatism

Interventions

DEVICE

Calculation of the arcuate intrasomal incisions

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.

Sponsors & Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

    collaborator INDUSTRY

  • OFTALVIST (Oftalmología Vistahermosa S.L)

    lead INDUSTRY

Principal Investigators

  • Pedro Tañá Rivero, Doctor · OFTALVIST (Oftalmología Vistahermosa S.L)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2023-04-18
Completion
2023-04-18

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053620 on ClinicalTrials.gov