Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

Beaver-Visitec

Status

Completed

Conditions

Cataract

Lens Opacities

Treatments

Device: IOL implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03297372

PHY1604

Details and patient eligibility

About

The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).

Full description

The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (PCO) grading.

Follow up will be up to 24 months postoperative.

Enrollment

121 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cataractous eyes with no comorbidity
Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Signed informed consent

Exclusion criteria

Irregular astigmatism
Age of patient < 45 years
Regular corneal astigmatism > 0.75 D on study eye as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
Difficulty for cooperation (distance from their home, general health condition)
Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
Any ocular comorbidity
History of ocular trauma or prior ocular surgery including refractive procedures
Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
Complicated surgery