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

NCT ID: NCT06229756

Last Updated: 2024-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-26

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EDOF Toric

Patient submitted to bilateral implantation of Asqelio EDOF Toric IOL

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

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
* 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
* Amblyopia
* Extremely shallow anterior camera
* Severe chronic uveítis
* Pregnant or nursing
* Rubella
* Mature/dense cataract that makes it difficult to examine the fundus preoperatively.
* Previous retinal detachment
* Concurrent participation in other research with drugs or clinical devices
* Expect to require another eye surgery during the study period
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AST Products, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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OftalVist Alicante

Alicante, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ASQE012022

Identifier Type: -

Identifier Source: org_study_id

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