Visual Quality and Performance of Eyes With Asqelio™ EDoF Toric Lenses (NCT06707545) | Clinical Trial Compass
CompletedNot Applicable
Visual Quality and Performance of Eyes With Asqelio™ EDoF Toric Lenses
Spain40 participantsStarted 2023-01-11
Plain-language summary
This study evaluates the optical quality and clinical performance of the Asqelio™ EDOF Toric intraocular lens (IOL) in patients undergoing cataract surgery or refractive lensectomy. The Asqelio™ EDOF Toric IOL aims to provide improved vision at various distances and correct astigmatism compared to monofocal IOLs. Postoperative outcomes, including visual clarity, refractive correction, and patient satisfaction, will be assessed three months after surgery.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 50 years or older who have undergone cataract surgery with phacoemulsification or refractive lensectomy, with bilateral implantation of the Asqelio EDOF toric IOL model ETLIO130C/ETPIO130C with a cylinder value of 0.0 D, or the spherical monofocal J\&J TECNIS 1-Piece IOL model ZCB00.
* Patients who have signed the informed consent form.
* Clear intraocular media, except for the presence of cataracts in both eyes prior to surgery.
* Postoperative potential visual acuity of 20/25 or better
Exclusion Criteria:
* Preoperative corneal astigmatism greater than 1.00D.
* 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).
* Choroidal hemorrhage.
* Microphthalmos.
* Severe corneal dystrophy.
* Uncontrolled or medically controlled glaucoma.
* Clinically significant macular changes.
* Severe concomitant ocular disease.
* Cataract unrelated to aging.
* Severe optic nerve atrophy.
* Diabetic retinopathy.
* Proliferative diabetic retinopathy.
* Amblyopia.
* Extremely shallow anterior chamber.
* Severe chronic uveitis.
* Pregnant or breastfeeding.
* Rubella.
* Mature/dense cataract preventing preoperative fundus examination.
* Previous retinal detachment.
* Concurrent participation in another drug or clinical device investigation.
* Expectation of needing another ocular surgery during the study period
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ocular dispersion index (OSI)
Timeframe: Three months after intraocular lens implantation
2
Higher order aberrations Root Mean Square (HORMS)
Timeframe: Three months after intraocular lens implantation
3
Ocular Spherical Aberration
Timeframe: Three months after intraocular lens implantation