NCT05776446

Brief 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, 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
Last Updated

March 20, 2023

Status Verified

February 1, 2023

Enrollment Period

5 days

First QC Date

February 13, 2023

Last Update Submit

March 17, 2023

Conditions

Cataract

Outcome Measures

Primary Outcomes (7)

  • Uncorrected distance visual acuity

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

    3 months after implantation

  • Best-corrected distance visual acuity

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

    3 months after implantation

  • Uncorrected intermediate visual acuity

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

    3 months after implantation

  • Distance-corrected intermediate visual acuity

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

    3 months after implantation

  • Uncorrected near visual acuity

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

    3 months after implantation

  • Distance-corrected near visual acuity

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

    3 months after implantation

  • Defocus curve

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

    3 months after implantation

Secondary Outcomes (5)

  • Manifest Refraction

    Preoperatively and 3 months after implantation

  • Adverse events

    3 months after implantation

  • Patient-reported outcomes CATQuest9SF

    3 months after implantation

  • Patient-reported outcomes PRSIQ

    3 months after implantation

  • Patient-reported outcomes PRVSQ

    3 months after implantation

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital La Arruzafa

Córdoba, Cordoba, 14012, Spain

Location

Related Publications (1)

  • 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.

    PMID: 36233798RESULT

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 20, 2023

Study Start

May 27, 2022

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

March 20, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)