Clinical Behavior of the 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

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-27

Study Completion Date

2022-09-01

Brief Summary

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The main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes (PRO). For that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation

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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

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 50 years or older submitted to cataract surgery with binocular implantation of Asqelio Trifocal TFLIO130C IOL
* Seeking spectacle independence after surgery
* IOL power between +5.0D y +34.0D
* Transparent ocular media, except for the cataract prior to surgery.
* Potential postoperatory visual acuity of 20/25 or better, as assessed prior to surgery

Exclusion Criteria

* Preoperatory corneal astigmatism greater than 1.0D
* Previous corneal surgery or trauma
* Irregular cornea (e.g. keratoconus)
* Choroidal hemorrhage
* Microftalmos
* Severe corneal dystrophy
* Uncontrolled or medically controlled glaucoma
* Clinically significant macular changes
* Severe concomitant ocular condition
* Cataract not age-related
* Severe optic nerve atrophy
* Diabetic retinopathy
* Ambyopia
* Extremely shallow anterior chamber
* Severe chronic uveitis
* Pregnancy or lactating
* Rubella
* Mature/dense cataract difficulting preoperatory eye fundus assessment
* Previous retinal detachment
* Concurrent participation in another investigation involving drugs or medical devices

Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes