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

NCT05053620 | Completed

• 1 other identifier: ARCUATAS
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Response to treatment

  Evaluation of the response to the procedure

  4 months after the procedure

Secondary Outcomes (2)

• Evaluation of the visual acuity

  4 months after the procedure

• Examination of the arcuate incisions

  4 months after the procedure

Study Arms (1)

Single arm

All patients.

Device: Calculation of the arcuate intrasomal incisions

Interventions

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.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• OFTALVIST (Oftalmología Vistahermosa S.L): lead
• Johnson & Johnson Surgical Vision, Inc.: collaborator

Study Sites (1)

OFTALVIST (Oftalmología Vistahermosa S.L.)

Alicante, 03015, Spain

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Pedro Tañá Rivero, Doctor

  OFTALVIST (Oftalmología Vistahermosa S.L)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 22, 2021
• Study Start: October 19, 2021
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)