Clinical trial NCT05065749: Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens
Official title: Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Keywords: cataract surgery
intraocular lens
multifocal refractive correction
Lead sponsor: AST Products, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-04
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: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse events
timeFrame: Six months after implantation
measure: Refraction
timeFrame: Six months after implantation
Secondary outcomes:
measure: Uncorrected visual acuity for distance (4m)
timeFrame: Six months after implantation
measure: Best-corrected visual acuity for distance (4m)
timeFrame: Six months after implantation
measure: Uncorrected visual acuity for intermediate
timeFrame: Six months after implantation
measure: Best-corrected visual acuity for intermediate
timeFrame: Six months after implantation
measure: Uncorrected visual acuity for near
timeFrame: Six months after implantation
measure: Best-corrected visual acuity for near
timeFrame: Six months after implantation
measure: Contrast sensitivity function (CSF)
timeFrame: Six months after implantation
measure: Defocus curve
timeFrame: Six months after implantation
Other outcomes:
Locations:
city: Jerez de la Frontera
country: Spain
facility: OftalVist Jerez de la Frontera
state: Cádiz
city: Alicante
country: Spain
facility: OftalVist Alicante
Study officials:
References: