Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens

February 13, 2023 updated by: AST Products, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Alicante, Spain, 03015
        • Oftalvist Alicante
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11408
        • OftalVist Jerez de la Frontera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients 50 years of age or older submitted to cataract surgery and implanted with the Asqelio Trifocal IOL TFLIO130C according to regular clinical practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Six months after implantation
Percentage of subjects with adverse events (Ocular and Not Ocular, Severe and Not Severe), including secondary surgical procedures
Six months after implantation
Refraction
Time Frame: Six months after implantation
Manifest refraction both monocular and binocularly using subjective methods
Six months after implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Uncorrected visual acuity for distance (4m)
Time Frame: Six months after implantation
Monocular visual acuity for distance (4m), without any additional correction, using ETDRS vision chart
Six months after implantation
Best-corrected visual acuity for distance (4m)
Time Frame: Six months after implantation
Monocular visual acuity for distance (4m), with the best correction for distance, using ETDRS vision chart
Six months after implantation
Uncorrected visual acuity for intermediate
Time Frame: Six months after implantation
Monocular visual acuity for intermediate distance (60cm), without any additional correction, using ETDRS vision chart
Six months after implantation
Best-corrected visual acuity for intermediate
Time Frame: Six months after implantation
Monocular visual acuity for intermediate distance (60cm), with the best correction for distance, using ETDRS vision chart
Six months after implantation
Uncorrected visual acuity for near
Time Frame: Six months after implantation
Monocular visual acuity for near distance (40cm), without any additional correction, using ETDRS vision chart
Six months after implantation
Best-corrected visual acuity for near
Time Frame: Six months after implantation
Monocular visual acuity for near distance (40cm), with the best correction for distance, using ETDRS vision chart
Six months after implantation
Contrast sensitivity function (CSF)
Time Frame: Six months after implantation
CSF with best correction, with and without induced glare, using the Clinical Trial Suite
Six months after implantation
Defocus curve
Time Frame: Six months after implantation
Defocus curve of visual performance varying the stimulus vergence from -4.0 D to +1.0 D in 0.5 D steps with the best correction for distance
Six months after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AST Products, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ASQT012021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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