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

Cataract Clinical Trial

— ARCUATAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05053620
• Other study ID #: ARCUATAS
• Status: Completed
• Start date: October 19, 2021
• Est. completion date: April 18, 2023

Study information

• Verified date: May 2023
• Source: OFTALVIST (Oftalmología Vistahermosa S.L)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 18, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

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.

Locations

Country	Name	City	State
Spain	OFTALVIST (Oftalmología Vistahermosa S.L.)	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
OFTALVIST (Oftalmología Vistahermosa S.L)	Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment	Evaluation of the response to the procedure	4 months after the procedure
Secondary	Evaluation of the visual acuity	Evaluation of the visual acuity	4 months after the procedure
Secondary	Examination of the arcuate incisions	Examination of the arcuate incisions using a slit amp	4 months after the procedure