Clinical trial NCT03803852: Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
Official title: Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric & PODEYE Toric
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age Related Cataracts
Astigmatism
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 750
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study involves 5 different groups. All groups will be investigated seperately.

Alcon Clareon toric group: 130 eyes Rayner RayOne group: 130 eyes Hoya Nanex group: 130 eyes Hoya Vivinex Impress: 120 eyes Rayner RayOne EMV toric group: 120 eyes PODEYE Toric: 120 eyes
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change of axial intraocular lens position
timeFrame: 7 months
Secondary outcomes:
measure: Decentration
timeFrame: 7 months
measure: Tilt
timeFrame: 7 months
measure: Anterior chamber depth
timeFrame: 1 month
measure: Best corrected visual acuity (BCVA)
timeFrame: 7 months
measure: UCIVA in the Alcon Clareon toric and Rayner RayOne EMV toric groups
timeFrame: 7 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna Allgemeines Krankenhaus
Study officials:
affiliation: Medical University Vienna
name: Rupert Menapace, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: