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

Study Overview

• Status: Completed
• Conditions: Cataract; Astigmatism
• Intervention / Treatment: Device: Calculation of the arcuate intrasomal incisions

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

• Study Contact: Name: Maria Cobo, Dr; Phone Number: +34963513304; Email: maria.cobo@oftalvist.es
• Study Contact Backup: Name: Maria Cobo; Phone Number: +34963513304; Email: maria.cobo@oftalvist.es

Study Locations

• Spain
  • Alicante, Spain, 03015
    • OFTALVIST (Oftalmología Vistahermosa S.L.)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are already going to undergo conventional cataract surgery by phacoemulsification in which there is low corneal astigmatism (up to 1.25 D) and it is corrected by means of arcuate intrastromal incisions with femtosecond laser following routine clinical practice.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Previous corneal surgery.
2. Keratoconus.
3. Corneal scars
4. Pterygium
5. Glaucoma

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single arm; All patients.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to treatment	Evaluation of the response to the procedure	4 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the visual acuity	Evaluation of the visual acuity	4 months after the procedure
Examination of the arcuate incisions	Examination of the arcuate incisions using a slit amp	4 months after the procedure

Collaborators and Investigators

• Sponsor: OFTALVIST (Oftalmología Vistahermosa S.L)
• Collaborators: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Principal Investigator: Pedro Tañá Rivero, Doctor, OFTALVIST (Oftalmología Vistahermosa S.L)

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): April 18, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: ARCUATAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A publication with the results of the study will be made available after study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No