Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

Completed

• Conditions: Cataract

• Registration Number: NCT05776446
• Lead Sponsor: AST Products, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-27
• Primary Completion: 2022-06-01
• Study Completion: 2022-09-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-03-17
• Last Update Submitted: 2023-03-17
• Study First Posted: 2023-03-20
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best-corrected distance visual acuity	3 months after implantation	Best-corrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Defocus curve	3 months after implantation	Binocular defocus curve with best correction for distance obtained varying mergence from -4.0D to +2.0D in 0.5D steps
Uncorrected distance visual acuity	3 months after implantation	Uncorrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Uncorrected intermediate visual acuity	3 months after implantation	Uncorrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Distance-corrected near visual acuity	3 months after implantation	Distance-corrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Uncorrected near visual acuity	3 months after implantation	Uncorrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units
Distance-corrected intermediate visual acuity	3 months after implantation	Distance-corrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units

Secondary Outcome Measures

Name	Time	Method
Manifest Refraction	Preoperatively and 3 months after implantation	Refraction determined monocularly by subjective refraction methods, in diopters
Adverse events	3 months after implantation	Percentage of subjects with adverse events (ocular and non ocular, severe and non severe), including secondary surgical interventions
Patient-reported outcomes CATQuest9SF	3 months after implantation	Patient reported outcomes were assessed by CATQuest9SF questionnaire
Patient-reported outcomes PRSIQ	3 months after implantation	Patient reported outcomes were assessed by patient-reported spectacle independence questionnaire (PRSIQ)
Patient-reported outcomes PRVSQ	3 months after implantation	Patient reported outcomes were assessed by the patient-reported visual symptoms questionnaire (PRVSQ)

Trial Locations

Locations (1)

Hospital La Arruzafa; 🇪🇸 Córdoba, Cordoba, Spain