Seguridad y Eficacia de la Lente Intraocular hidrófoba de diseño biasférico AsqelioTM Monofocal

Sponsor

OFTALVIST (Oftalmología Vistahermosa S.L) (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06056154

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

50.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Pseudophakia	Device: LIO ASQELIO TM monofocal QLIO130C

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

Seguridad y Eficacia de la Lente Intraocular hidrófoba de diseño biasférico AsqelioTM Monofocal

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

To evaluate the safety of the ASQELIO monofocal LIO implant. [At least 24 months after implantation.]
To evaluate the efficacy of the ASQELIO monofocal LIO implant. [At least 24 months after implantation.]

Secondary Outcome Measures

To evaluate the residual refractive error of the ASQELIO monofocal LIO implant. [At least 24 months after implantation.]
To evaluate the material stability (glistening) of the ASQELIO monofocal LIO implant. [At least 24 months after implantation.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oftalmología Vistahermosa SL	Alicante		Spain	46026

Sponsors and Collaborators

OFTALVIST (Oftalmología Vistahermosa S.L)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

OFTALVIST (Oftalmología Vistahermosa S.L)

ClinicalTrials.gov Identifier:

NCT06056154

Other Study ID Numbers:

ASQM012023

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Pseudophakia

Study Results

No Results Posted as of Sep 28, 2023