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CataractNCT05776446

Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

An observational study of Cataract, run by AST Products, Inc. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Cataract
How many people
25 participants
Where
1 siteSpain
Study dates
27 May 2022to 1 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects are regular clinic patients submitted to bilateral conventional cataract surgery by phacoemulsification, who wanted to correct their refractive error and presbyopia, and thus were implanted with the trifocal IOL subject to study by common clinical practice

Who may be able to join

  • 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

Who cannot join

  • Preoperatory corneal astigmatism greater than 1.0D
  • Previous corneal surgery or trauma
  • Irregular cornea (e.g. keratoconus)
  • Choroidal hemorrhage
  • Microftalmos
  • Severe corneal dystrophy
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital La Arruzafa

    Córdoba, Cordoba, 14012

Other trials in Spain

About this study

Official title: Retrospective Study on the Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens With Follow-up at 3 Months

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

Conditions
Cataract
Medical subject headings
Cataract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uncorrected distance visual acuity

    Uncorrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    Measured: 3 months after implantation

  2. Best-corrected distance visual acuity

    Best-corrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    Measured: 3 months after implantation

  3. Uncorrected intermediate visual acuity

    Uncorrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    Measured: 3 months after implantation

  4. Distance-corrected intermediate visual acuity

    Distance-corrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    Measured: 3 months after implantation

  5. Uncorrected near visual acuity

    Uncorrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    Measured: 3 months after implantation

  6. Distance-corrected near visual acuity

    Distance-corrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    Measured: 3 months after implantation

  7. Defocus curve

    Binocular defocus curve with best correction for distance obtained varying mergence from -4.0D to +2.0D in 0.5D steps

    Measured: 3 months after implantation

Secondary outcomes (5)

  1. Manifest Refraction

    Refraction determined monocularly by subjective refraction methods, in diopters

    Measured: Preoperatively and 3 months after implantation

  2. Adverse events

    Percentage of subjects with adverse events (ocular and non ocular, severe and non severe), including secondary surgical interventions

    Measured: 3 months after implantation

  3. Patient-reported outcomes CATQuest9SF

    Patient reported outcomes were assessed by CATQuest9SF questionnaire

    Measured: 3 months after implantation

  4. Patient-reported outcomes PRSIQ

    Patient reported outcomes were assessed by patient-reported spectacle independence questionnaire (PRSIQ)

    Measured: 3 months after implantation

  5. Patient-reported outcomes PRVSQ

    Patient reported outcomes were assessed by the patient-reported visual symptoms questionnaire (PRVSQ)

    Measured: 3 months after implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2023
  2. Study start27 May 2022
  3. Primary completion1 Jun 2022
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05776446
Sponsor's protocol ID
ASQT022022
Status last verified
Feb 2023
First submitted
13 Feb 2023
Last updated
20 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cano-Ortiz A, Sanchez-Ventosa A, Gonzalez-Cruces T, Cerdan-Palacios D, Diaz-Mesa V, Gallego-Ordonez R, Galvez-Gomez T, Garcia Parrizas JA, Zurera Baena J, Villarrubia-Cuadrado A. Visual Performance, Satisfaction, and Spectacle Independence after Implantation of a New Hydrophobic Trifocal Intraocular Lens. J Clin Med. 2022 Oct 8;11(19):5931. doi: 10.3390/jcm11195931.

    PubMed 36233798

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract, run by AST Products, Inc. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uncorrected distance visual acuity (time frame: 3 months after implantation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05776446, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.

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