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OpenTrials
Completed

NCT Number: NCT05895396

Clinical Outcome After Implantation of Two Different Multifocal Toric IOLs: Liberty (677MTY) and PanOptix®

This study is to compare the rotational stability, visual outcome and patient satisfaction after implantation with either Liberty 677MTY, a multifocal diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. (Zsámbék, Hungary) or the multifocal toric IOL PanOptix®, manufactured by Alcon.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retinaszervíz

Veszprém, 8200, Hungary

About this study

According to numerous estimations, 15% to 29% of patients with cataract have more than 1.5 diopters of refractive astigmatism. Corneal astigmatism can be reduced with a variety of surgical techniques including selective positioning of the phacoemulsification incision, corneal relaxing incision, implantation of toric IOLs, photorefractive keratectomy and there are first results of implantation of short arc-length intrastromal corneal ring segments for correcting astigmatism and myopia . The use of toric IOLs to reduce visually significant keratometric astigmatism offers a rational, more predictable and stable method of refractive correction. Implanting a toric intraocular lens offers the possibility of correcting not only spherical equivalent of refraction, but also astigmatism. The success of a toric IOL can be judged not only by its ability to reduce refractive astigmatism immediately postoperatively, but also by its ability to maintain a stable position in the capsular bag in the longer term. Even a small rotational deviation of the toric IOL from its intended axis can result in large reduction of the astigmatic correction.

The purpose of this study is to evaluate and compare the visual outcomes, spectacle independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation of either the Liberty 677MTY (a multifocal diffractive apodized toric intraocular lens- diffractive-refractive IOL based on EPS technology manufactured by Medicontur Ltd. Zsámbék, Hungary) or the multifocal toric PanOptix® IOL, manufactured by Alcon.

Who can participate

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

Inclusion criteria

The enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt.

Exclusion criteria

  • astigmatism less than 1 dpt
  • irregular astigmatism
  • diabetic retinopathy
  • iris neovascularisation
  • serious intraoperative complications
  • congenital eye abnormality
  • glaucoma
  • pseudoexfoliation syndrom
  • amblyopia
  • uveitis
  • long-term anti-inflammatory treatment
  • AMD (advanced AMD)
  • retinal detachment
  • prior ocular surgery in personal medical history
  • corneal diseases
  • severe retinal diseases (dystrophy, degeneration)
  • severe myopia (if required IOL power is lower than 10 D)
  • inadequate visualization of the fundus on preoperative examination
  • patients deemed by the clinical investigator because of any systemic disease.
  • eye trauma in medical history intraoperative exclusions:
  • tear in capsulorhexis
  • zonular dehiscence
  • posterior capsular rupture
  • vitreous loss and other unexpected surgical complication

Treatment and study plan

Primary outcomes

  1. Rotational stability

    Time frame: Day 1

    Rotational stability will be measured using slit lamp images of the implanted lens

  2. Rotational stability

    Time frame: 3 months

    Rotational stability will be measured using slit lamp images of the implanted lens

  3. Rotational stability

    Time frame: 1 year

    Rotational stability will be measured using slit lamp images of the implanted lens

Secondary outcomes

  1. Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)

    Time frame: 1 month

    Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart.

  2. Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)

    Time frame: 3 months

    Monocular and binocular visual aquity will be measured at far, intermediate and near by standard ETDRS chart

  3. Visual outcome (UDVA, CDVA, UIVA, DCIVA, UNVA, DCNVA)

    Time frame: 1 year

    Monocular and binocular visual aquity will be measured at far, intermediate and near distances by standard ETDRS chart

  4. Contrast sensitivity defocus curve

    Time frame: 3 months

    Contrast sensitivity defocus curve will be assessed using the Multifocal Lense Analyser iPAD application.

  5. Contrast sensitivity defocus curve

    Time frame: 1 year

    Contrast sensitivity defocus curve will be assessed using the Multifocal Lense Analyser iPAD application.

  6. Contrast sensitivity

    Time frame: 1 year

    Contrast sensitivity in photopic and mesopic light conditions with or without glare will be assessed one year postoperatively using CSV-1000

  7. Multifocality (Visual Acuity Defocus Curve)

    Time frame: 3 months

    The multifocality of the lens will be evaluated also by monocular and binocular visual acuity defocus curves (VADC) using the multifocal lens analyser iPAD application

  8. Multifocality (Visual Acuity Defocus Curve)

    Time frame: 1 year

    The multifocality of the lens will be evaluated also by monocular and binocular visual acuity defocus curves using the multifocal lens analyser iPAD application.

  9. Patient satisfaction

    Time frame: 3 months

    Patient satisfaction will be measures with the VFQ-14 questionnaire

  10. Patient satisfaction

    Time frame: 1 year

    Patient satisfaction will be measures with the VFQ-14 questionnaire

Other outcomes

  1. Safety outcome - Intraoperative complications

    Time frame: Day1 postoperatively

    Intraoperative complications of cataract surgery

    • Posterior capsular or zonular rupture
    • Vitreous loss/anterior vitrectomy or aspiration
    • Iris/ciliary body injury
    • Loss of nuclear material into vitreous
    • Suprachoroidal haemorrhage
    • Retrobulbar haemorrhage
  2. Safety outcome - Postoperative complications

    Time frame: Month1 postoperatively

    Postoperative complications of cataract surgery

    • Cystoid macular oedema
    • Iris abnormalities
    • Corneal oedema
    • Wound leak or rupture
    • IOL dislocation, removal, or exchange
    • Inflammation (Endophthalmitis, anterior chamber cells, anterior chamber flare, hypopyon)
    • Retinal tear, break, or detachment
    • Persistent iritis
    • Elevated intraocular pressure
    • Pupillary block
    • Cornea status
  3. Safety outcome - Complications of IOL implantation

    Time frame: Month 12 postoperatively

    Complications of IOL implantation

    • Posterior capsular opacification (PCO)
    • Opacification, IOL discoloration

Sponsors and collaborators

Lead sponsor

Medicontur Medical Engineering Ltd

Industry

Registry information

Official study title

Comparison of Clinical Outcome After Implantation With Two Different Multifocal Toric Intraocular Lens: Liberty Trifocal 677MTY (Medicontur) and PanOptix® Multifocal Toric (Alcon) Lens, With Respect to Rotational Stability, Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2023
Registry last updated
Aug 30, 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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