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OpenTrials
Completed

NCT Number: NCT05053620

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OFTALVIST (Oftalmología Vistahermosa S.L.)

Alicante, 03015, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous corneal surgery.
  • Keratoconus.
  • Corneal scars
  • Pterygium
  • Glaucoma

Treatment and study plan

Calculation of the arcuate intrasomal incisions

Device

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.

Primary outcomes

  1. Response to treatment

    Time frame: 4 months after the procedure

    Evaluation of the response to the procedure

Secondary outcomes

  1. Evaluation of the visual acuity

    Time frame: 4 months after the procedure

    Evaluation of the visual acuity

  2. Examination of the arcuate incisions

    Time frame: 4 months after the procedure

    Examination of the arcuate incisions using a slit amp

Sponsors and collaborators

Lead sponsor

OFTALVIST (Oftalmología Vistahermosa S.L)

Industry

Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

Registry information

Acronym: ARCUATAS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2021
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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