Clinical trial NCT06101472: Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.
Official title: Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Keywords: Cataract
Lead sponsor: AST Products, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 63
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rotational stability of the implant
timeFrame: During 3 months after IOL implantation
measure: Visual acuity
timeFrame: During 3 months after IOL implantation
Secondary outcomes:
measure: Refraction
timeFrame: During 3 months after IOL implantation
measure: Adverse events
timeFrame: During 3 months after IOL implantation
measure: Satisfaction and quality of vision questionnaire
timeFrame: During 3 months after IOL implantation
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Oftalvist Alicante
city: Madrid
country: Spain
facility: OftalVist Madrid
city: Valencia
country: Spain
facility: OftalVist Valencia
Study officials:
affiliation: Oftalmología Vistahermosa SL
name: Pedro Tañá, Dr
role: PRINCIPAL_INVESTIGATOR
References: