Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens

NCT05065749 | Unknown

• 1 other identifier: ASQT012021
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens Asqelio Trifocal IOL TFLIO130C in healthy subjects submitted to non-traumatic cataract surgery. This clinical performance will be assessed in terms of refractive error, visual performance at different distances, incidence of adverse events and complications following implantation, and patient satisfaction.

Conditions

Cataract

Keywords

cataract surgery; intraocular lens; multifocal refractive correction

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Percentage of subjects with adverse events (Ocular and Not Ocular, Severe and Not Severe), including secondary surgical procedures

  Six months after implantation

• Refraction

  Manifest refraction both monocular and binocularly using subjective methods

  Six months after implantation

Secondary Outcomes (8)

• Uncorrected visual acuity for distance (4m)

  Six months after implantation

• Best-corrected visual acuity for distance (4m)

  Six months after implantation

• Uncorrected visual acuity for intermediate

  Six months after implantation

• Best-corrected visual acuity for intermediate

  Six months after implantation

• Uncorrected visual acuity for near

  Six months after implantation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 50 years of age or older submitted to cataract surgery and implanted with the Asqelio Trifocal IOL TFLIO130C according to regular clinical practice

You may qualify if:

• Patients submitted to cataract surgery and implanted with Asqelio Trifocal IOL TFLIO130C
• Patients signing a consent form
• Patients seeking spectacle-independence following surgery
• IOL power between +5.00 and +34.00 D
• Transparent intraocular media, except for the cataract prior to surgery, in both eyes
• Postoperatory potential visual acuity of 20/25 or better.

You may not qualify if:

• Preoperatory corneal astigmatism greater than 0.75D
• Patients not providing informed consent
• Previous corneal surgery or trauma
• Irregular cornea (i.e. keratoconus)
• Choroidal hemorrhage
• Microophthalmos
• Severe corneal dystrophy
• Uncontrolled or medically controlled glaucoma
• Clinically significant macular changes
• Severe concomitant ocular disease
• Not age-related cataract
• Severe optic nerve atrophy
• Diabetic retinopathy
• Ambyopia
• Extremely shallow anterior chamber

Sponsors & Collaborators

• AST Products, Inc.: lead

Study Sites (2)

OftalVist Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11408, Spain

Location

OftalVist Alicante

Alicante, 03015, Spain

Location

Related Publications (1)

• Tana-Rivero P, Tana-Sanz P, Tana-Sanz S, Montes-Mico R, Cervino A. Recognition vs resolution charts for defocus curve determination in trifocal intraocular lenses. J Cataract Refract Surg. 2024 Sep 1;50(9):942-946. doi: 10.1097/j.jcrs.0000000000001491.

  PMID: 38780434 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: March 7, 2022
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

ES (2)