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

Last updated: January 30, 2024
Sponsor: AST Products, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Eye Disease

Eye Disorders/infections

Treatment

ASQELIO Toric Biaspheric Monofocal Lens

Clinical Study ID

NCT06101472
ASQM022023
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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.

Study Design

Total Participants: 63
Treatment Group(s): 1
Primary Treatment: ASQELIO Toric Biaspheric Monofocal Lens
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
October 31, 2024

Study 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.

Connect with a study center

  • Oftalvist Alicante

    Alicante, 03013
    Spain

    Active - Recruiting

  • OftalVist Madrid

    Madrid, 28006
    Spain

    Active - Recruiting

  • OftalVist Valencia

    Valencia, 46004
    Spain

    Active - Recruiting

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