Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens

AST Products, Inc.30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cataract

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Severe chronic uveitis * Pregnant or lactating * Rubella * Mature/Dense cataract sifficulting preoperative fundus assessment * Previous retinal detachment * Concurrent participation in other investigation using drugs or clinical devices * Expecting ocular surgery within the study period

Locations (2)

OftalVist Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

OftalVist Alicante

Alicante, Spain

Outcomes

Primary Outcomes

Adverse events

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