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Search / Trial NCT06707545

Visual Quality and Performance of Eyes With Asqelio™ EDoF Toric Lenses

Launched by AST PRODUCTS, INC. · Nov 24, 2024

Trial Information

Current as of July 07, 2025

Completed

Keywords

Intraocular Lens Extended Depth Of Focus Cataract Surgery Optical Quality

ClinConnect Summary

Cataract surgery is one of the most common procedures worldwide, typically involving the replacement of the cloudy natural lens with an intraocular lens (IOL). Traditional monofocal IOLs correct vision for a single distance but do not address intermediate or near vision, leading to dependence on glasses. The Asqelio™ EDOF Toric IOL is designed to provide extended depth of focus, smoother transitions across distances, and astigmatism correction, potentially enhancing overall visual quality and reducing the need for glasses.

This study compares the optical performance and patient outcomes of...

Gender

ALL

Eligibility criteria

  • 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

About Ast Products, Inc.

AST Products, Inc. is a leading clinical trial sponsor dedicated to advancing innovative medical solutions through rigorous research and development. With a focus on enhancing patient care, the company specializes in the design and execution of clinical trials that evaluate the safety and efficacy of cutting-edge therapeutic products. Leveraging a team of experienced professionals and robust methodologies, AST Products, Inc. is committed to adhering to the highest regulatory standards while fostering collaboration with healthcare providers and research institutions. Their mission is to bring transformative healthcare solutions to market, ultimately improving outcomes for patients globally.

Locations

Córdoba, Cordoba, Spain

Patients applied

0 patients applied

Trial Officials

Antonio Cano, MD, PhD

Principal Investigator

Hospital La Arruzafa

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported