Status:

UNKNOWN

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

Lead Sponsor:

AST Products, Inc.

Conditions:

Cataract

Eligibility:

All Genders

22+ years

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 ...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 1 2024

Estimated Enrollment :

63 Patients enrolled

Trial Details

Trial ID

NCT06101472

Start Date

February 1 2024

End Date

October 1 2024

Last Update

January 31 2024

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Oftalvist Alicante

Alicante, Spain, 03013

2

OftalVist Madrid

Madrid, Spain, 28006

3

OftalVist Valencia

Valencia, Spain, 46004