Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05776446
• Other study ID #: ASQT022022
• Status: Completed
• Start date: May 27, 2022
• Est. completion date: September 1, 2022

Study information

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

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
Spain	Hospital La Arruzafa	Córdoba	Cordoba

Sponsors (1)

Lead Sponsor	Collaborator
AST Products, Inc.

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Cano-Ortiz A, Sanchez-Ventosa A, Gonzalez-Cruces T, Cerdan-Palacios D, Diaz-Mesa V, Gallego-Ordonez R, Galvez-Gomez T, Garcia Parrizas JA, Zurera Baena J, Villarrubia-Cuadrado A. Visual Performance, Satisfaction, and Spectacle Independence after Implantat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected distance visual acuity	Uncorrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Primary	Best-corrected distance visual acuity	Best-corrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Primary	Uncorrected intermediate visual acuity	Uncorrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Primary	Distance-corrected intermediate visual acuity	Distance-corrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Primary	Uncorrected near visual acuity	Uncorrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Primary	Distance-corrected near visual acuity	Distance-corrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Primary	Defocus curve	Binocular defocus curve with best correction for distance obtained varying mergence from -4.0D to +2.0D in 0.5D steps	3 months after implantation
Secondary	Manifest Refraction	Refraction determined monocularly by subjective refraction methods, in diopters	Preoperatively and 3 months after implantation
Secondary	Adverse events	Percentage of subjects with adverse events (ocular and non ocular, severe and non severe), including secondary surgical interventions	3 months after implantation
Secondary	Patient-reported outcomes CATQuest9SF	Patient reported outcomes were assessed by CATQuest9SF questionnaire	3 months after implantation
Secondary	Patient-reported outcomes PRSIQ	Patient reported outcomes were assessed by patient-reported spectacle independence questionnaire (PRSIQ)	3 months after implantation
Secondary	Patient-reported outcomes PRVSQ	Patient reported outcomes were assessed by the patient-reported visual symptoms questionnaire (PRVSQ)	3 months after implantation