Evaluating the ASQELIO Toric Lens for Cataract Surgery
Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.
This study is testing how well the ASQELIO Toric lens stays in place and helps people see better after cataract surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 63 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | AST Products, Inc. Industry-sponsored |
| Locations | 3 sites (Alicante and 2 other locations) |
| Trial ID | NCT06101472 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the rotational stability and clinical performance of the ASQELIO Toric intraocular lens (IOL) in patients undergoing cataract surgery. Participants will have their preoperative examinations conducted and will be evaluated postoperatively at one day, one week, one month, and three months after surgery. The study focuses on ensuring that the toric lens remains stable after implantation to effectively correct corneal astigmatism and improve visual outcomes. Data will be collected from patients receiving the ASQELIO lens in routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 22 years or older who are undergoing cataract surgery and are planned for postoperative emmetropia.
Not a fit: Patients with preoperative corneal astigmatism less than 0.75D or those with certain ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of cataract surgery by ensuring better visual outcomes through stable lens performance.
How similar studies have performed: While the specific ASQELIO lens has not been extensively studied, the use of toric lenses in cataract surgery has shown promising results in correcting astigmatism in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Alicante and 2 other locations
- Oftalvist Alicante — Alicante, Spain (Recruiting)
- OftalVist Madrid — Madrid, Spain (Recruiting)
- OftalVist Valencia — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Pedro Tañá, Dr — Oftalmología Vistahermosa SL
- Study coordinator: Maria Cobo, Dr
- Email: maria.cobo@oftalvist.es
- Phone: +34963513304
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.