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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03803852
• Other study ID #: 1978/2018
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: October 14, 2024

Study information

• Verified date: October 2023
• Source: Medical University of Vienna
• Contact: Rupert Menapace, Prof.Dr.
• Phone: 0043-1-40400
• Email: rupert.menapace[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 630
• Est. completion date: October 14, 2024
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 95 Years

Eligibility

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)

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

Related Conditions & MeSH terms

• Age Related Cataracts
• Astigmatism
• Cataract

Intervention

Device:
• Intraocular Lens Implantation
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 on the axis according to the steep meridian of the cornea

Locations

Country	Name	City	State
Austria	Medical University of Vienna Allgemeines Krankenhaus	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of axial intraocular lens position	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°)	7 months
Secondary	Decentration	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"	7 months
Secondary	Tilt	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"	7 months
Secondary	Anterior chamber depth	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	1 month
Secondary	Best corrected visual acuity (BCVA)	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)	7 months
Secondary	UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups	Uncorrected Intermediate Visual Acuity mono or bilateral	7 months