Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens

Cataract Clinical Trial

Official title:

Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05065749
• Other study ID #: ASQT012021
• Status: Active, not recruiting
• Start date: March 7, 2022
• Est. completion date: September 2023

Study information

• Verified date: February 2023
• Source: AST Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
Spain	OftalVist Alicante	Alicante
Spain	OftalVist Jerez de la Frontera	Jerez de la Frontera	Cádiz

Sponsors (1)

Lead Sponsor	Collaborator
AST Products, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Percentage of subjects with adverse events (Ocular and Not Ocular, Severe and Not Severe), including secondary surgical procedures	Six months after implantation
Primary	Refraction	Manifest refraction both monocular and binocularly using subjective methods	Six months after implantation
Secondary	Uncorrected visual acuity for distance (4m)	Monocular visual acuity for distance (4m), without any additional correction, using ETDRS vision chart	Six months after implantation
Secondary	Best-corrected visual acuity for distance (4m)	Monocular visual acuity for distance (4m), with the best correction for distance, using ETDRS vision chart	Six months after implantation
Secondary	Uncorrected visual acuity for intermediate	Monocular visual acuity for intermediate distance (60cm), without any additional correction, using ETDRS vision chart	Six months after implantation
Secondary	Best-corrected visual acuity for intermediate	Monocular visual acuity for intermediate distance (60cm), with the best correction for distance, using ETDRS vision chart	Six months after implantation
Secondary	Uncorrected visual acuity for near	Monocular visual acuity for near distance (40cm), without any additional correction, using ETDRS vision chart	Six months after implantation
Secondary	Best-corrected visual acuity for near	Monocular visual acuity for near distance (40cm), with the best correction for distance, using ETDRS vision chart	Six months after implantation
Secondary	Contrast sensitivity function (CSF)	CSF with best correction, with and without induced glare, using the Clinical Trial Suite	Six months after implantation
Secondary	Defocus curve	Defocus curve of visual performance varying the stimulus vergence from -4.0 D to +1.0 D in 0.5 D steps with the best correction for distance	Six months after implantation