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

Completed

• Conditions: Astigmatism; Cataract
• Interventions: Device: Calculation of the arcuate intrasomal incisions

• Registration Number: NCT05053620
• Lead Sponsor: OFTALVIST (Oftalmología Vistahermosa S.L)

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.

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 Timeline

• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Study Start: 2021-10-19
• Primary Completion: 2023-04-18
• Study Completion: 2023-04-18
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm	Calculation of the arcuate intrasomal incisions	All patients.

Primary Outcome Measures

Name	Time	Method
Response to treatment	4 months after the procedure	Evaluation of the response to the procedure

Secondary Outcome Measures

Name	Time	Method
Examination of the arcuate incisions	4 months after the procedure	Examination of the arcuate incisions using a slit amp
Evaluation of the visual acuity	4 months after the procedure	Evaluation of the visual acuity

Trial Locations

Locations (1)

OFTALVIST (Oftalmología Vistahermosa S.L.); 🇪🇸 Alicante, Spain