Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.

The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation.

Information will be obtained from patients operated by routine clinical practice with toric monofocal ASQELIO IOL in at least one eye. After confirmation of inclusion, the preoperative examination will be performed, and after surgery an evaluation will be performed the following day, one week, one month and three months after surgery.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: ASQELIO Toric Biaspheric Monofocal Lens

Detailed Description

In cataract surgery, the opacified lens is removed by phacoemulsification and replaced by an artificial IOL.The most common risk of cataract surgery is the development of a condition called posterior capsular opacification (PCO) that causes further deterioration of visual function. Toric intraocular lenses correct corneal astigmatism and avoid residual refractive errors in these subjects. For their efficacy in this refractive error correction, it is essential that, once implanted, these lenses are rotationally stable.The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens during the first 3 months after implantation.

All patients participating in the study are candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation model TLIO130 from AST Products, Inc., with CE marking.

• Study Type: Observational
• Enrollment (Estimated): 63

Contacts and Locations

• Study Contact: Name: Maria Cobo, Dr; Phone Number: +34963513304; Email: maria.cobo@oftalvist.es

Study Locations

• Spain
  • Alicante, Spain, 03013
    • Recruiting
    • Oftalvist Alicante
    • Sub-Investigator: Cristina Tello Elordi, OD
    • Contact: José M Rubio, OD; Phone Number: +34965141500
    • Principal Investigator: Pedro Tañá Rivero, MD, PhD
    • Sub-Investigator: Paz Orts Vila, MD
    • Sub-Investigator: Enrique Artiaga Elordi, MD
    • Sub-Investigator: Jose J Muñoz Tomás, MD
    • Sub-Investigator: Jose J Rubio, OD
  • Madrid, Spain, 28006
    • Recruiting
    • OftalVist Madrid
    • Contact: Fátima Martínez Galdón, OD; Phone Number: +34915 42 60 10
    • Principal Investigator: Marta Ibarz Barbera, MD
    • Sub-Investigator: Enrique Aguado García, MD
    • Sub-Investigator: Fátima Martínez Galdón, OD
    • Sub-Investigator: Elena Caballero, OD
  • Valencia, Spain, 46004
    • Recruiting
    • Oftalvist Valencia
    • Sub-Investigator: Jose J Muñoz Tomás, MD
    • Contact: Rafael Pastor Pascual, OD; Phone Number: +34963 513304
    • Principal Investigator: Francisco Pastor Pascual, MD, PhD
    • Sub-Investigator: Rafael Pastor Pascual, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects who are candidates for cataract surgery and implantation of toric monofocal ASQELIO IOL in at least one of their eyes.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Preoperative corneal astigmatism less than 0.75D
• Patients who do not provide informed consent
• Patients who do not understand the study procedure.
• Previous corneal surgery or trauma.
• Irregular cornea (e.g. keratoconus).
• Microphthalmos.
• Severe corneal dystrophy.
• Pregnant or breastfeeding'.
• Rubella
• Mature/dense cataract making eye bottom preoperative examination difficult.
• Previous retinal detachment.
• Concurrent participation in other research with drugs or clinical devices.
• Expect to require another eye surgery during the study period.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pseudophakic subjects implanted with the ASQELIO toric IOL; Adult subjects undergoing cataract surgery by routine clinical practice with ASQELIO Toric Biaspheric Monofocal Lens in at least one eye.	Device: ASQELIO Toric Biaspheric Monofocal Lens; Intraocular lens implantation in cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotational stability of the implant	Evaluated at each visit by analysis of slit-lamp backlight images, following the method described by Wolffsohn and Buckhurst. By means of backlighting, the IOL markings indicating the axis in which the astigmatic power is located will be observed and by image analysis it will be determined and quantified whether the lens has been rotated.	During 3 months after IOL implantation
Visual acuity	Best corrected distance visual acuity in LogMAR units using the ETDRS chart	During 3 months after IOL implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refraction	Using subjective refraction methods.	During 3 months after IOL implantation
Adverse events	Adverse events are obtained from solicited and spontaneous comments from the subjects and from observations made by the investigator.	During 3 months after IOL implantation
Satisfaction and quality of vision questionnaire	Collected from solicited and spontaneous comments from the subjects, as well as the Catquest-9SF questionnaire, validated in Spanish. The subjective assessment of the quality of vision will be determined by an additional questionnaire about the presence of visual symptoms related to positive dysphotopsias (halos, glare and glare).	During 3 months after IOL implantation

Collaborators and Investigators

• Sponsor: AST Products, Inc.
• Investigators: Principal Investigator: Pedro Tañá, Dr, Oftalmología Vistahermosa SL

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cataract
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ASQM022023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No