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OpenTrials
Completed

NCT Number: NCT05776446

Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

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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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital La Arruzafa

Córdoba, Cordoba, 14012, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Uncorrected distance visual acuity

    Time frame: 3 months after implantation

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

  2. Best-corrected distance visual acuity

    Time frame: 3 months after implantation

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

  3. Uncorrected intermediate visual acuity

    Time frame: 3 months after implantation

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

  4. Distance-corrected intermediate visual acuity

    Time frame: 3 months after implantation

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

  5. Uncorrected near visual acuity

    Time frame: 3 months after implantation

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

  6. Distance-corrected near visual acuity

    Time frame: 3 months after implantation

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

  7. Defocus curve

    Time frame: 3 months after implantation

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

Secondary outcomes

  1. Manifest Refraction

    Time frame: Preoperatively and 3 months after implantation

    Refraction determined monocularly by subjective refraction methods, in diopters

  2. Adverse events

    Time frame: 3 months after implantation

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

  3. Patient-reported outcomes CATQuest9SF

    Time frame: 3 months after implantation

    Patient reported outcomes were assessed by CATQuest9SF questionnaire

  4. Patient-reported outcomes PRSIQ

    Time frame: 3 months after implantation

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

  5. Patient-reported outcomes PRVSQ

    Time frame: 3 months after implantation

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

Sponsors and collaborators

Lead sponsor

AST Products, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 20, 2023
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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