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Completed

NCT Number: NCT06190925

Clinical Results of Asqelio Trifocal Toric Diffractive Intraocular Lens

The goal of this observational prospective clinical study is to learn about the clinical outcomes three months after binocular implantation of Asqelio Trifocal Toric IOL in 30 patients submitted to cataract surgery following standard clinical practice. The main questions it aims to answer are: How rotationally stable is the lens after implantation and how effective is in the correction of refractive astigmatism.

Additionally, the visual performance at different distances will be assessed, as well as the patient-reported outcomes.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OftalVist Alicante

Alicante, 03015, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients submitted to cataract surgery with phacoemulsification with bilateral implantation of Asqelio Trifocal Toric IOL to avoid residual astigmatism
  • Patient signing informed consent
  • Clear intraocular media, except for cataracts in both eyes prior to surgery
  • Monocular potential postoperative visual acuity of 20/25 or better

Exclusion criteria

  • Corneal astigmatism lower than 0.75D
  • Patients who do not provide informed consent
  • Patients who do not understand the study procedure
  • Previous corneal surgery or trauma
  • Irregular cornea (e.g. keratoconus)
  • Choroidal hemorrhage
  • Microphtalmos
  • Severe corneal dystrophy
  • Uncontrolled or medically controlled glaucoma
  • Clinically significant macular changes
  • Concomitant severe eye disease
  • Non-age-related cataract
  • Severe optic nerve atrophy
  • Diabetic retinopathy
  • Proliferative diabetic retinopathy
  • Amblyopia
  • Extremely shallow anterior camera
  • Severe chronic uveítis
  • Pregnant or nursing
  • Rubella
  • Mature/dense cataract that makes it difficult to examine the fundus preoperatively.
  • Previous retinal detachment
  • Concurrent participation in other research with drugs or clinical devices
  • Expect to require another eye surgery during the study period

Treatment and study plan

Primary outcomes

  1. Refraction

    Time frame: 3 months after implantation

    Manifest residual refraction after implantation of IOL using subjective refraction methods (D)

Secondary outcomes

  1. Corrected Visual acuity at distance

    Time frame: 3 months after implantation

    Visual acuity at 4m with refractive correction (LogMAR units)

  2. Corrected Visual acuity at intermediate distance

    Time frame: 3 months after implantation

    Visual acuity at 60cm with refractive correction for distance (LogMAR units)

  3. Corrected Visual acuity at near distance

    Time frame: 3 months after implantation

    Visual acuity at 40cm with refractive correction for distance (LogMAR units)

  4. Uncorrected Visual acuity at distance

    Time frame: 3 months after implantation

    Visual acuity at 4m without correction (LogMAR units)

  5. Uncorrected Visual acuity at intermediate distance

    Time frame: 3 months after implantation

    Visual acuity at 60cm without correction (LogMAR units)

  6. Uncorrected Visual acuity at near distance

    Time frame: 3 months after implantation

    Visual acuity at 40cm without correction (LogMAR units)

  7. Binocular defocus curve

    Time frame: 3 months after implantation

    Defocus curve obtained in binocular conditions from +2.00D to -4.00D vergence in 0.5 steps (LogMAR units)

  8. Rotational stability

    Time frame: 3 months after implantation

    Change in IOL axis position determined with slit lamp (degrees)

  9. Contrast sensitivity function

    Time frame: 3 months after implantation

    Contrast sensitivity determined with best correction for distance, under photopic and mesopic conditions, with and without induced glare, using the Clinical Trial Suite (CTS, M&S Technologies, Niles, IL, EEUU) (Log CS units)

  10. Patient reported outcomes - Satisfaction

    Time frame: 3 months after implantation

    Patient reported outcomes obtained by means of the CATQuest9SF questionnaire. 9 items with 4 response options, ranging from 4 for "very great difficulty/very dissatisfied" to 1 for "no difficulty/very satisfied", and a "cannot decide" additional option, which is treated as missing data.

  11. Patient reported outcomes - Visual Symptoms

    Time frame: 3 months after implantation

    Patient reported outcomes on incidence and intensity of visual symptoms obtained by means of a visual symptoms questionnaire. It explores the frequency, intensity and bothersome of 10 different and common visual symptoms. Patients are asked to respond with 4 response options to the frequency of the symptoms, from 1 for "Never" to 4 "Very often", the intensity of the symptom, from 1 for "None" to 4 for "Severe", and the level of bothersome of the symptom, from 1 for "None" to 4 for "A lot".

Sponsors and collaborators

Lead sponsor

AST Products, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Jan 8, 2024

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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