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Recruiting

NCT Number: NCT03803852

Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric

The investigational devices are approved intraocular lenses (IOL) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Within the study, three different IOLs will be investigated and separately evaluated. Cataract surgery with IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be postoperative refraction, visual acuity, slitlamp examination, and rotation of the IOL within 1 hour, 1 week, 1 month and 4-7 months.

In the Alcon Clareon toric, RayOne EMV toric and PODEYE Toric group, patients receive a toric IOL according to their preoperative astigmatism

Recruiting

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Key information

Conditions

Age Related Cataracts Astigmatism Eye Diseases Refractive Errors

Age range

45 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna Allgemeines Krankenhaus

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Rupert Menapace, Prof.

CONTACT

[email protected]

014040066300

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Uni- or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
  • Age: 45 to 95
  • Need for spherical IOL correction between 10.00 and 30.00 D
  • Need for spherical IOL correction between +6.00 and +30.00 D (Alcon Clareon toric group)
  • Need for spherical IOL correction between +10.00 and +25.00 D (Rayner RayOne EMV toric group)
  • Preoperative pupil dilation in mydriasis ≥ 7.0 mm (Hoya, Rayner groups)
  • Astigmatism of at least 1.0 Diopters (Alcon Clareon toric and Rayner RayOne EMV toric groups and PODEYE Toric)
  • Pupil dilation >5.5mm (Alcon Clareon toric Rayner RayOne EMV toric group)

Exclusion criteria

  • Preceding ocular surgery or trauma
  • Recurrent intraocular inflammation of unknown etiology
  • Uncontrolled glaucoma
  • Uncontrolled systemic or ocular disease
  • Blind fellow eye
  • Microphthalmus
  • Corneal abnormality (Corneal scaring)
  • History of uveitis/iritis
  • Iris neovascularization
  • Proliferative diabetic retinopathy
  • Pregnancy
  • Lactation
  • Females of childbearing age will be asked if pregnancy is possible

Treatment and study plan

Intraocular Lens Implantation

Device

Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impressinto the capsular bag using an injector, after removing of the human cristalline lens.

Implantation of the Alcon Clareon toric and Rayner RayOne EMV toric IOL and PODEYE Toric IOL on the axis according to the steep meridian of the cornea

Primary outcomes

  1. Change of axial intraocular lens position

    Time frame: 7 months

    Change in axis position of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric or PODEYE Toric from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)

Secondary outcomes

  1. Decentration

    Time frame: 7 months

    Decentration of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric or PODEYE Toric will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in milimeter"

  2. Tilt

    Time frame: 7 months

    Tilt of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon toric or Rayner RayOne EMV toric or PODEYE Toric will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"

  3. Anterior chamber depth

    Time frame: 1 month

    The anterior chamber depth (Axial position of the IOL) of the intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress or Alcon Clareon or Rayner RayOne EMV toric or PODEYE Toric will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter

  4. Best corrected visual acuity (BCVA)

    Time frame: 7 months

    BCVA will be measured at 1 week, 1 month and 4 to 7 months. The BCVA will be described as the minimum angle of resolution (logMar)

  5. UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups

    Time frame: 7 months

    Uncorrected Intermediate Visual Acuity mono or bilateral

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Schartmueller, Dr.

CONTACT

[email protected]

0043-1-40400 ext. 79450

Rupert Menapace, Prof.Dr.

CONTACT

[email protected]

0043-1-40400 ext. - 66300

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Jan 15, 2019
Registry last updated
May 14, 2025

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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