Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation (PHY1801)

Beaver-Visitec

Status

Completed

Conditions

Cataract

Lens Opacities

Treatments

Device: Micropure 1.2.3.

Study type

Interventional

Funder types

Industry

Identifiers

NCT03423524

PHY1801

Details and patient eligibility

About

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.

Full description

This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have bilateral implantation of monofocal intraocular lenses Micropure 1.2.3. (PhysIOL, Liège, Belgium)

The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3.

The device under investigation (Micropure 1.2.3.) is a monofocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 50 patients will be recruited for this clinical study and receive a bilateral implantation of Micropure 1.2.3. intraocular lens.

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 2 Years.

Enrollment

20 patients

Sex

All

Ages

45+ years old

Volunteers

Accepts 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 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°
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
Patients who do not give informed consent