Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery

NCT06229756 | Unknown

• 1 other identifier: ASQE012022
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess the clinical outcomes of binocular implantation of Asqelio EDOF Toric IOLs in healthy cataract patients. The main questions it aims to answer are:

• What is the visual performance at different distances 3 months after implantation of Asqelio EDOF Toric in both eyes?
• What is the amount of residual refractive error following the implantation?
• What is the contrast sensitivity of patients 3 months after implantation of Asqelio EDOF Toric in both eyes?
• What is the optical quality of the eye implanted with Asqelio EDOF Toric IOL?
• What is the incidence and severity of visual symptoms after implantation of Asqelio EDOF Toric?
• What is the level of patient satisfaction after implantation of Asqelio EDOF Toric? For this purpose, participants will be submitted to a comprehensive visual and refractive assessment, following common clinical practice, 3 months after binocular implantation of Asqelio EDOF Toric IOLs, and asked to complete visual symptoms and patient satisfaction questionnaires.

Conditions

Cataract

Outcome Measures

Primary Outcomes (7)

• Uncorrected Monocular Visual acuity for distance

  Visual acuity without additional correction determined at a distance of 4 m in LogMAR units

  3 months after implantation

• Uncorrected Monocular Visual acuity for intermediate distance

  Visual acuity without additional correction determined at a distance of 67 cm in LogMAR units

  3 months after implantation

• Uncorrected Monocular Visual acuity for near distance

  Visual acuity without additional correction determined at a distance of 40 cm in LogMAR units

  3 months after implantation

• Corrected Monocular Visual acuity for distance

  Visual acuity with best correction determined at a distance of 4 m in LogMAR units

  3 months after implantation

• Corrected Monocular Visual acuity for intermediate distance

  Visual acuity with best correction determined at a distance of 67 cm in LogMAR units

  3 months after implantation

• Corrected Monocular Visual acuity for near distance

  Visual acuity with best correction determined at a distance of 40 cm in LogMAR units

  3 months after implantation

• Refractive error

  Residual refractive error after implantation obtained by subjective refraction methods

  3 months after implantation

Secondary Outcomes (10)

• Contrast sensitivity function under photopic conditions

  3 months after implantation

• Contrast sensitivity function under mesopic conditions

  3 months after implantation

• Contrast sensitivity function under photopic conditions with glare

  3 months after implantation

• Contrast sensitivity function under mesopic conditions with glare

  3 months after implantation

• Binocular defocus curve

  3 months after implantation

Study Arms (1)

EDOF Toric

Patient submitted to bilateral implantation of Asqelio EDOF Toric IOL

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects submitted to bilateral cataract surgery with implantation of extended depth of focus IOLs according to common clinical practice

You may qualify if:

• Patients 50 years old or more submitted to bilateral cataract surgery and implanted with Asqelio EDOF toric IOL, with cylinder value of 0.0 D.
• Patients signing informed consent
• Transparent media except for the cataracts
• Potential postoperatoria visual acuity of 20/25 or better

You may not qualify if:

• 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
• Microphtalmos
• Severe corneal dystrophy
• Uncontrolled or medically controlled glaucoma
• Clinically significant macular changes
• Concomitant severe eye disease
• Non-age-related cataract
• Severe optic nerve atrophy
• Diabetic retinopathy
• Proliferative diabetic retinopathy

Sponsors & Collaborators

• AST Products, Inc.: lead

Study Sites (1)

OftalVist Alicante

Alicante, 03015, Spain

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: October 26, 2022
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 29, 2024

Record last verified: 2023-01

Locations

ES (1)