Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

Retrospective Study on the Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens With Follow-up at 3 Months

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05776446

Enrollment

Registered

2023-03-20

Start date

2022-05-27

Completion date

2022-09-01

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 99 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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
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
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 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
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 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 distance visual acuity	3 months after implantation	Uncorrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units

Secondary

Measure	Time frame	Description
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)
Manifest Refraction	Preoperatively and 3 months after implantation	Refraction determined monocularly by subjective refraction methods, in diopters

Countries

Spain

Outcome results