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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101472
• Other study ID #: ASQM022023
• Status: Recruiting
• Start date: February 2024
• Est. completion date: October 2024

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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• 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 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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• ASQELIO Toric Biaspheric Monofocal Lens
Intraocular lens implantation in cataract surgery

Locations

Country	Name	City	State
Spain	Oftalvist Alicante	Alicante
Spain	OftalVist Madrid	Madrid
Spain	OftalVist Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
AST Products, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Visual acuity	Best corrected distance visual acuity in LogMAR units using the ETDRS chart	During 3 months after IOL implantation
Secondary	Refraction	Using subjective refraction methods.	During 3 months after IOL implantation
Secondary	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
Secondary	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