Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens

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

2022-03-07

Study Completion Date

2023-09-30

Brief Summary

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The study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens Asqelio Trifocal IOL TFLIO130C in healthy subjects submitted to non-traumatic cataract surgery.

This clinical performance will be assessed in terms of refractive error, visual performance at different distances, incidence of adverse events and complications following implantation, and patient satisfaction.

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Detailed Description

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Conditions

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Cataract

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients submitted to cataract surgery and implanted with Asqelio Trifocal IOL TFLIO130C
* Patients signing a consent form
* Patients seeking spectacle-independence following surgery
* IOL power between +5.00 and +34.00 D
* Transparent intraocular media, except for the cataract prior to surgery, in both eyes
* Postoperatory potential visual acuity of 20/25 or better.

Exclusion Criteria

* Preoperatory corneal astigmatism greater than 0.75D
* Patients not providing informed consent
* Previous corneal surgery or trauma
* Irregular cornea (i.e. keratoconus)
* Choroidal hemorrhage
* Microophthalmos
* Severe corneal dystrophy
* Uncontrolled or medically controlled glaucoma
* Clinically significant macular changes
* Severe concomitant ocular disease
* Not age-related cataract
* Severe optic nerve atrophy
* Diabetic retinopathy
* Ambyopia
* Extremely shallow anterior chamber
* Severe chronic uveitis
* Pregnant or lactating
* Rubella
* Mature/Dense cataract sifficulting preoperative fundus assessment
* Previous retinal detachment
* Concurrent participation in other investigation using drugs or clinical devices
* Expecting ocular surgery within the study period

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No