Clinical trial NCT06190925: Clinical Results of Asqelio Trifocal Toric Diffractive Intraocular Lens
Official title: Clinical Results of Asqelio Trifocal Toric Diffractive Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: cataract surgery
intraocular lens
Lead sponsor: AST Products, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Regular clinical patients submitted to bilateral conventional cataract surgery using phacoemulsification and implanted with Asqelio Trifocal Toric to eliminate refractive error and presbyopia, also requiring toric correction to avoid residual astigmatism

Brief summary: The goal of this observational prospective clinical study is to learn about the clinical outcomes three months after binocular implantation of Asqelio Trifocal Toric IOL in 30 patients submitted to cataract surgery following standard clinical practice. The main questions it aims to answer are: How rotationally stable is the lens after implantation and how effective is in the correction of refractive astigmatism.

Additionally, the visual performance at different distances will be assessed, as well as the patient-reported outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients submitted to cataract surgery with phacoemulsification with bilateral implantation of Asqelio Trifocal Toric IOL to avoid residual astigmatism
* Patient signing informed consent
* Clear intraocular media, except for cataracts in both eyes prior to surgery
* Monocular potential postoperative visual acuity of 20/25 or better

Exclusion Criteria:

* Corneal astigmatism lower than 0.75D
* Patients who do not provide informed consent
* Patients who do not understand the study procedure
* 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 uveítis
* Pregnant or nursing
* Rubella
* Mature/dense cataract that makes it difficult to examine the fundus preoperatively.
* Previous retinal detachment
* Concurrent participation in other research with drugs or clinical devices
* Expect to require another eye surgery during the study period

Primary outcomes:
measure: Refraction
timeFrame: 3 months after implantation
Secondary outcomes:
measure: Corrected Visual acuity at distance
timeFrame: 3 months after implantation
measure: Corrected Visual acuity at intermediate distance
timeFrame: 3 months after implantation
measure: Corrected Visual acuity at near distance
timeFrame: 3 months after implantation
measure: Uncorrected Visual acuity at distance
timeFrame: 3 months after implantation
measure: Uncorrected Visual acuity at intermediate distance
timeFrame: 3 months after implantation
measure: Uncorrected Visual acuity at near distance
timeFrame: 3 months after implantation
measure: Binocular defocus curve
timeFrame: 3 months after implantation
measure: Rotational stability
timeFrame: 3 months after implantation
measure: Contrast sensitivity function
timeFrame: 3 months after implantation
measure: Patient reported outcomes - Satisfaction
timeFrame: 3 months after implantation
measure: Patient reported outcomes - Visual Symptoms
timeFrame: 3 months after implantation
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: OftalVist Alicante
Study officials:
References: