Clinical trial NCT05776446: Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens
Official title: Retrospective Study on the Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens With Follow-up at 3 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: AST Products, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-20
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are regular clinic patients submitted to bilateral conventional cataract surgery by phacoemulsification, who wanted to correct their refractive error and presbyopia, and thus were implanted with the trifocal IOL subject to study by common clinical practice

Brief summary: The main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes (PRO). For that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation


Eligibility criteria: Inclusion Criteria:

* 50 years or older submitted to cataract surgery with binocular implantation of Asqelio Trifocal TFLIO130C IOL
* Seeking spectacle independence after surgery
* IOL power between +5.0D y +34.0D
* Transparent ocular media, except for the cataract prior to surgery.
* Potential postoperatory visual acuity of 20/25 or better, as assessed prior to surgery

Exclusion Criteria:

* Preoperatory corneal astigmatism greater than 1.0D
* Previous corneal surgery or trauma
* Irregular cornea (e.g. keratoconus)
* Choroidal hemorrhage
* Microftalmos
* Severe corneal dystrophy
* Uncontrolled or medically controlled glaucoma
* Clinically significant macular changes
* Severe concomitant ocular condition
* Cataract not age-related
* Severe optic nerve atrophy
* Diabetic retinopathy
* Ambyopia
* Extremely shallow anterior chamber
* Severe chronic uveitis
* Pregnancy or lactating
* Rubella
* Mature/dense cataract difficulting preoperatory eye fundus assessment
* Previous retinal detachment
* Concurrent participation in another investigation involving drugs or medical devices

Primary outcomes:
measure: Uncorrected distance visual acuity
timeFrame: 3 months after implantation
measure: Best-corrected distance visual acuity
timeFrame: 3 months after implantation
measure: Uncorrected intermediate visual acuity
timeFrame: 3 months after implantation
measure: Distance-corrected intermediate visual acuity
timeFrame: 3 months after implantation
measure: Uncorrected near visual acuity
timeFrame: 3 months after implantation
measure: Distance-corrected near visual acuity
timeFrame: 3 months after implantation
measure: Defocus curve
timeFrame: 3 months after implantation
Secondary outcomes:
measure: Manifest Refraction
timeFrame: Preoperatively and 3 months after implantation
measure: Adverse events
timeFrame: 3 months after implantation
measure: Patient-reported outcomes CATQuest9SF
timeFrame: 3 months after implantation
measure: Patient-reported outcomes PRSIQ
timeFrame: 3 months after implantation
measure: Patient-reported outcomes PRVSQ
timeFrame: 3 months after implantation
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital La Arruzafa
state: Cordoba
Study officials:
References:
citation: Cano-Ortiz A, Sanchez-Ventosa A, Gonzalez-Cruces T, Cerdan-Palacios D, Diaz-Mesa V, Gallego-Ordonez R, Galvez-Gomez T, Garcia Parrizas JA, Zurera Baena J, Villarrubia-Cuadrado A. Visual Performance, Satisfaction, and Spectacle Independence after Implantation of a New Hydrophobic Trifocal Intraocular Lens. J Clin Med. 2022 Oct 8;11(19):5931. doi: 10.3390/jcm11195931.