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

NCT ID: NCT03688399

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2021-09-21

Brief Summary

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.

Detailed 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.

Conditions

Cataract; Lens Opacity; Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IOL Implantation experimental

hydrophobic, trifocal intraocular lens POD L GF with light distribution far \> intermediate \> near

Group Type: EXPERIMENTAL

IOL implantation experimental

Intervention Type: DEVICE

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> intermediate \> near

IOL Implantation Comparator

hydrophobic, trifocal intraocular lens POD F GF with light distribution far \> near \> intermediate

Group Type: ACTIVE_COMPARATOR

IOL implantation comparator

Intervention Type: DEVICE

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> near \> intermediate

Interventions

IOL implantation experimental

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> intermediate \> near

Intervention Type: DEVICE

IOL implantation comparator

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> near \> intermediate

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zoltan Nagy, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University - Department of Ophthalmology

Locations

Semmelweis University - Department of Ophthalmology

Budapest, , Hungary

Countries

Hungary

Other Identifiers

PHY1707

Identifier Type: -

Identifier Source: org_study_id