Clinical trial NCT06935565: Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens
Official title: Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: multifocal IOL
optical quality
visual performance
Lead sponsor: AST Products, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of usual clinical practice who have undergone conventional cataract surgery by phacoemulsification and wish to eliminate their refractive error and correct their presbyopia

Brief summary: The goal of this observational study is to evaluate whether the Asqelio™ Trifocal intraocular lens (IOL) can improve refractive outcomes and optical quality in patients (aged ≥45 years) undergoing cataract surgery or clear lens exchange, including both male and female participants. The main questions it aims to answer are:

* Does the Asqelio™ Trifocal IOL provide accurate refractive correction with minimal residual refractive error?
* Does the lens reduce light distortion and provide good visual acuity at multiple distances (far, intermediate, near)?

Researchers will not use a comparison group, as this is a post-marketing, single-arm observational study.

Participants will undergo bilateral implantation of the Asqelio™ Trifocal IOL during cataract or lens replacement surgery and attend a study follow-up exam approximately 270±90 days post-surgery.

Complete evaluations including:

* Manifest refraction testing
* Uncorrected and corrected visual acuity at far, intermediate, and near distances
* Binocular defocus curve analysis
* Contrast sensitivity testing
* Light distortion analysis using a Light Distortion Analyzer
* Patient-reported outcomes via the Catquest-9SF and visual symptoms questionnaires.


Eligibility criteria: Inclusion Criteria:

* Patients 50 years of age or older undergoing cataract surgery by phacoemulsification and binocular IOL implant AsqelioTM Trifocal TFLIO130C
* Independence of use of glasses after surgery.
* IOL power between +5.0D and +34.0D
* Transparent intraocular media except for cataracts in both eyes.
* Potential postoperative visual acuity of 20/25 or better.

Exclusion Criteria:

* Preoperative corneal astigmatism greater than 1.0D
* 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
* Amblyopia
* Extremely shallow anterior camera
* Severe chronic uveitis
* Pregnant or nursing
* Rubella
* Mature/dense cataract that makes it difficult to examine the eye fundus preoperatively.
* Previous retinal detachment
* Concurrent participation in other research with drugs or clinical devices

Primary outcomes:
measure: Residual refraction
timeFrame: 270±90 days after surgery
measure: Light Distortion Index
timeFrame: 270±90 days from surgery
Secondary outcomes:
measure: Visual acuity
timeFrame: 270±90 days after surgery
measure: Binocular defocus curve
timeFrame: 270±90 days after surgery
measure: Contrast sensitivity
timeFrame: 270±90 days after surgery
measure: Patient-Reported Outcomes - CATQuest9SF
timeFrame: 270±90 days after surgery
measure: Patient-Reported Outcomes - Visual symptoms
timeFrame: 270±90 days after surgery
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Clinica Baviera
Study officials:
References: