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

Recruiting

• Conditions: Cataract
• Interventions: Device: ASQELIO Toric Biaspheric Monofocal Lens

• Registration Number: NCT06101472
• Lead Sponsor: AST Products, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-09-20
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-26
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Study Start: 2024-02
• Primary Completion: 2024-08
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pseudophakic subjects implanted with the ASQELIO toric IOL	ASQELIO Toric Biaspheric Monofocal Lens	Adult subjects undergoing cataract surgery by routine clinical practice with ASQELIO Toric Biaspheric Monofocal Lens in at least one eye.

Primary Outcome Measures

Name	Time	Method
Rotational stability of the implant	During 3 months after IOL implantation	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.
Visual acuity	During 3 months after IOL implantation	Best corrected distance visual acuity in LogMAR units using the ETDRS chart

Secondary Outcome Measures

Name	Time	Method
Refraction	During 3 months after IOL implantation	Using subjective refraction methods.
Satisfaction and quality of vision questionnaire	During 3 months after IOL implantation	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).
Adverse events	During 3 months after IOL implantation	Adverse events are obtained from solicited and spontaneous comments from the subjects and from observations made by the investigator.

Trial Locations

Locations (3)

Oftalvist Alicante; 🇪🇸 Alicante, Spain

OftalVist Madrid; 🇪🇸 Madrid, Spain

OftalVist Valencia; 🇪🇸 Valencia, Spain