Clinical trial NCT05053620: Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Astigmatism
Lead sponsor: OFTALVIST (Oftalmología Vistahermosa S.L)
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Surgical Vision, Inc.
First posted: 2021-09-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Response to treatment
timeFrame: 4 months after the procedure
Secondary outcomes:
measure: Evaluation of the visual acuity
timeFrame: 4 months after the procedure
measure: Examination of the arcuate incisions
timeFrame: 4 months after the procedure
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: OFTALVIST (Oftalmología Vistahermosa S.L.)
Study officials:
affiliation: OFTALVIST (Oftalmología Vistahermosa S.L)
name: Pedro Tañá Rivero, Doctor
role: PRINCIPAL_INVESTIGATOR
References: