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

Not Applicable

Recruiting

• Conditions: Age Related Cataracts; Astigmatism
• Interventions: Device: Intraocular Lens Implantation

• Registration Number: NCT03803852
• Lead Sponsor: Medical University of Vienna

Brief Summary

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 and RayOne EMV toric groups, patients receive a toric IOL according to their preoperative astigmatism

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-15
• Study Start: 2019-01-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-06-14
• Study Completion: 2024-10-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 630

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)
• Pupil dilation >5.5mm (Alcon Clareon toric Rayner RayOne EMV toric group)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
45°	Intraocular Lens Implantation	Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 45°
90°	Intraocular Lens Implantation	Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 90°
0°	Intraocular Lens Implantation	Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impress on axis 0°
135°	Intraocular Lens Implantation	Implantation of an intraocular lens Rayner RayOne or Hoya Nanex or Hoya Vivinex Impresson axis 135°

Primary Outcome Measures

Name	Time	Method
Change of axial intraocular lens position	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 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 Outcome Measures

Name	Time	Method
Tilt	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 will be measured with the Casia 2 OCT. Tilt will be described as "Tilt in degrees at a certain axis"
Best corrected visual acuity (BCVA)	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)
UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups	7 months	Uncorrected Intermediate Visual Acuity mono or bilateral
Anterior chamber depth	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 will be measured with the Casia 2 OCT after 1 month. The anterior chamber depth will be measured in milimeter
Decentration	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 will be measured with the Casia 2 OCT. Decentration will be described as "Decentration in milimeter"

Trial Locations

Locations (1)

Medical University of Vienna Allgemeines Krankenhaus; 🇦🇹 Vienna, Austria