Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.

AST Products

Status: Enrolling

Conditions: Cataract

Treatments: Device: ASQELIO Toric Biaspheric Monofocal Lens

Study type: Observational

Funder types: Industry

Identifiers

NCT06101472

ASQM022023

Details and patient eligibility

About

The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation.

Information will be obtained from patients operated by routine clinical practice with toric monofocal ASQELIO IOL in at least one eye. After confirmation of inclusion, the preoperative examination will be performed, and after surgery an evaluation will be performed the following day, one week, one month and three months after surgery.

Full description

In cataract surgery, the opacified lens is removed by phacoemulsification and replaced by an artificial IOL.The most common risk of cataract surgery is the development of a condition called posterior capsular opacification (PCO) that causes further deterioration of visual function. Toric intraocular lenses correct corneal astigmatism and avoid residual refractive errors in these subjects. For their efficacy in this refractive error correction, it is essential that, once implanted, these lenses are rotationally stable.The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens during the first 3 months after implantation.

All patients participating in the study are candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation model TLIO130 from AST Products, Inc., with CE marking.

Enrollment: 63 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with LIO ASQELIO.
• Subjects for whom postoperative emmetropia was planned (±0.5 D spherical equivalent)

Exclusion criteria

• Preoperative corneal astigmatism less than 0.75D
• Patients who do not provide informed consent
• Patients who do not understand the study procedure.
• Previous corneal surgery or trauma.
• Irregular cornea (e.g. keratoconus).
• Microphthalmos.
• Severe corneal dystrophy.
• Pregnant or breastfeeding'.
• Rubella
• Mature/dense cataract making eye bottom preoperative examination difficult.
• Previous retinal detachment.
• Concurrent participation in other research with drugs or clinical devices.
• Expect to require another eye surgery during the study period.

Trial design

63 participants in 1 patient group

Pseudophakic subjects implanted with the ASQELIO toric IOL

Description:

Adult subjects undergoing cataract surgery by routine clinical practice with ASQELIO Toric Biaspheric Monofocal Lens in at least one eye.

Treatment:

Device: ASQELIO Toric Biaspheric Monofocal Lens