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

NCT06056154 | Enrolling By Invitation

• 1 other identifier: ASQM012023
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract; Pseudophakia

Outcome Measures

Primary Outcomes (3)

• Incidence of Posterior capsular opacity

  Incidence of PCO

  24 months after IOL implantation

• Intensity of Posterior capsular opacity

  Intensity of PCO determined using LOCSIII Classification

  24 months after IOL implantation

• Visual acuity

  Best corrected distance visual acuity in LogMAR units using the ETDRS chart

  At least 24 months after IOL implantation

Secondary Outcomes (3)

• Refraction

  At least 24 months after IOL implantation

• Incidence of Glistening

  At least 24 months after IOL implantation

• Intensity of Glistening

  24 months after IOL implantation

Study Arms (1)

Patients undergoing routine clinical practice with ASQELIOTM monofocal LIO model QLIO130C.

Data will be extracted retrospectively from their medical records and prospectively in a single follow-up visit. All procedures performed are according to standard clinical practice.

Device: LIO ASQELIO TM monofocal QLIO130C

Interventions

LIO ASQELIO TM monofocal QLIO130C DEVICE

Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.

Patients undergoing routine clinical practice with ASQELIOTM monofocal LIO model QLIO130C.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects undergoing cataract surgery, implanted with ASQELIO monofocal model QLIO130C, and with a follow-up of more than 24 months.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AST Products, Inc.: lead

Study Sites (1)

Oftalmología Vistahermosa SL

Alicante, 46026, Spain

Location

MeSH Terms

Conditions

Cataract; Pseudophakia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: January 17, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

ES (1)