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

NCT ID: NCT06101472

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2024-10-31

Brief Summary

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.

Detailed 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.

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pseudophakic subjects implanted with the ASQELIO toric IOL

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

ASQELIO Toric Biaspheric Monofocal Lens

Intervention Type: DEVICE

Intraocular lens implantation in cataract surgery

Interventions

ASQELIO Toric Biaspheric Monofocal Lens

Intraocular lens implantation in cataract surgery

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AST Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Tañá, Dr

Role: PRINCIPAL_INVESTIGATOR

Oftalmología Vistahermosa SL

Locations

Oftalvist Alicante

Alicante, , Spain

Site Status: RECRUITING

OftalVist Madrid

Madrid, , Spain

Site Status: RECRUITING

OftalVist Valencia

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Maria Cobo, Dr

Role: CONTACT

maria.cobo@oftalvist.es

+34963513304

Facility Contacts

José M Rubio, OD

Role: primary

+34965141500

Fátima Martínez Galdón, OD

Role: primary

+34915 42 60 10

Rafael Pastor Pascual, OD

Role: primary

+34963 513304

Other Identifiers

ASQM022023

Identifier Type: -

Identifier Source: org_study_id