Safety and Efficacy of the Hydrophobic Intraocular Lens AsqelioTM Monofocal With Biaspheric Design

Cataract Clinical Trial

Official title:

Safety and Efficacy of the Hydrophobic Intraocular Lens AsqelioTM Monofocal With Biaspheric Design

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06056154
• Other study ID #: ASQM012023
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: AST Products, Inc.
• Contact: Maria Cobo, Dr.
• Phone: +34963513304
• Email: maria.cobo[@]oftalvist.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.

Description:

This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products, Inc, Billerica, USA, will be studied in patients implanted according to standard clinical practice. Twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C.
• Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned.

Exclusion Criteria:

• Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR.
• Previous corneal surgery.
• Rubella or surgery due to traumatic cataract.
• Ocular trauma or refractive surgery.
• Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study

Related Conditions & MeSH terms

• Cataract
• Pseudophakia

Intervention

Device:
• LIO ASQELIO TM monofocal QLIO130C
Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.

Locations

Country	Name	City	State
Spain	Oftalmología Vistahermosa SL	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
AST Products, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Posterior capsular opacity	Incidence of PCO	24 months after IOL implantation
Primary	Intensity of Posterior capsular opacity	Intensity of PCO determined using LOCSIII Classification	24 months after IOL implantation
Primary	Visual acuity	Best corrected distance visual acuity in LogMAR units using the ETDRS chart	At least 24 months after IOL implantation
Secondary	Refraction	Residual refractive error in diopters determined objectively	At least 24 months after IOL implantation
Secondary	Incidence of Glistening	Incidence of IOL glistening	At least 24 months after IOL implantation
Secondary	Intensity of Glistening	Intensity of IOL glistening. It will be evaluated by examining the center of the IOL optical zone with the pupil dilated using a slit lamp. The intensity of glistening will be graded as the number of glistening in the central region according to the following scale: 0 = absent, 1 = traceable (countable vacuoles), 2=moderate (low density of countless vacuoles), and 3=severe (high density of countless vacuoles).	24 months after IOL implantation