Clinical Results of Asqelio Trifocal Toric Diffractive Intraocular Lens

NCT06190925 | Completed

• 1 other identifier: ASQT042021
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational prospective clinical study is to learn about the clinical outcomes three months after binocular implantation of Asqelio Trifocal Toric IOL in 30 patients submitted to cataract surgery following standard clinical practice. The main questions it aims to answer are: How rotationally stable is the lens after implantation and how effective is in the correction of refractive astigmatism. Additionally, the visual performance at different distances will be assessed, as well as the patient-reported outcomes.

Conditions

Cataract

Keywords

cataract surgery; intraocular lens

Outcome Measures

Primary Outcomes (1)

• Refraction

  Manifest residual refraction after implantation of IOL using subjective refraction methods (D)

  3 months after implantation

Secondary Outcomes (11)

• Corrected Visual acuity at distance

  3 months after implantation

• Corrected Visual acuity at intermediate distance

  3 months after implantation

• Corrected Visual acuity at near distance

  3 months after implantation

• Uncorrected Visual acuity at distance

  3 months after implantation

• Uncorrected Visual acuity at intermediate distance

  3 months after implantation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Regular clinical patients submitted to bilateral conventional cataract surgery using phacoemulsification and implanted with Asqelio Trifocal Toric to eliminate refractive error and presbyopia, also requiring toric correction to avoid residual astigmatism

You may qualify if:

• Patients submitted to cataract surgery with phacoemulsification with bilateral implantation of Asqelio Trifocal Toric IOL to avoid residual astigmatism
• Patient signing informed consent
• Clear intraocular media, except for cataracts in both eyes prior to surgery
• Monocular potential postoperative visual acuity of 20/25 or better

You may not qualify if:

• Corneal astigmatism lower 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)
• Choroidal hemorrhage
• Microphtalmos
• Severe corneal dystrophy
• Uncontrolled or medically controlled glaucoma
• Clinically significant macular changes
• Concomitant severe eye disease
• Non-age-related cataract
• Severe optic nerve atrophy
• Diabetic retinopathy
• Proliferative diabetic retinopathy

Sponsors & Collaborators

• AST Products, Inc.: lead

Study Sites (1)

OftalVist Alicante

Alicante, 03015, Spain

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: November 3, 2022
• Primary Completion: November 6, 2023
• Study Completion: December 12, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

ES (1)