NCT06101472

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 63 (estimated)
• Sponsor: AST Products, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	ASQELIO Toric Biaspheric Monofocal Lens	Intraocular lens implantation in cataract surgery

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-08-01
• Completion: 2024-10-01
• First posted: 2023-10-26
• Last updated: 2024-01-31

Locations

3 sites across 1 country: Spain