Comparison of Clinical Outcomes POD L GF vs POD F GF (PHY1707)

Beaver-Visitec

Status

Completed

Conditions

Lens Opacity

Cataract

Presbyopia

Treatments

Device: IOL implantation experimental

Device: IOL implantation comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT03688399

PHY1707

Details and patient eligibility

About

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.

Full description

This is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.

Primary and secondary endpoint data will be collected at the 6 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Enrollment

53 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Cataractous eyes and/or patients suffering from presbyopia with no ocular comorbidity
Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Signed informed consent

Exclusion criteria

Age of patient <40 years
Irregular astigmatism
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)
AMD suspicious eyes
Complicated surgery