Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery

NCT ID: NCT04054427

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2022-05-31

Brief Summary

Controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study to investigate visual performance after implantation of a trifocal IOL (PhysIOL Pod L GF) in patients that underwent refractive surgery.

Detailed Description

This clinical investigation is a controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study whereby patients undergoing routine cataract surgery that previously underwent refractive surgery prior to being screened will have bilateral implantation of trifocal intraocular lens FineVision POD L GF (PhysIOL, Liège, Belgium).

The study purpose is to collect clinical data on visual acuity, contrast sensitivity and patient reported outcomes obtained on patients with cataracts and/or suffering from presbyopia that underwent refractive surgery prior to the IOL implantation.

The device under investigation (FineVision POD L GF) is a trifocal 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 28 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD L GF intraocular lens.

Subjects participating in the trial will attend a total of 9 study visits (1 preoperative, 2 operative and 6 postoperative) over a period of 6 months.

Conditions

Cataract; Lens Opacities; Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IOL implantation experimental

hydrophobic, trifocal intraocular lens POD L GF

Group Type: EXPERIMENTAL

IOL implantation experimental

Intervention Type: DEVICE

Implantation of trifocal IOL POD L GF consisting of hydrophobic material

Interventions

IOL implantation experimental

Implantation of trifocal IOL POD L GF consisting of hydrophobic material

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Cataracteous eyes with no comorbidity;
• Post LASIK, post PRK/surface ablation or post RK (radial keratotomy) patients with day of refractive surgery minimum 24 months before IOL implantation;
• Calculated IOL power is within the range of the study IOLs;
• Fulfill CHRU (Centre Hospitalier Regional Universitaire) internal criteria for multifocal lenses implantation on post-refractive surgery patients.
• Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes or suffer from presbyopia;
• Clear intraocular media other than cataract;
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
• Signed informed consent

Exclusion Criteria

• Age of patient < 45 years;
• Irregular topographic examination where limitation in clinical outcomes are expected.
• Patients that underwent presbyopia correcting refractive surgery (e.g. PresbyLASIK, SUPRACOR, INTRACOR)
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
• Subjects with AMD suspicious eyes as determined by OCT examination;
• Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
• Traumatic cataract;
• History or presence of macular edema;
• Concurrent or previous (within 30 days) participation in another drug or device investigation;
• Instability of keratometry or biometry measurements;
• Ocular hypertension or glaucoma;
• Significant dry eye;
• Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgement (reason to be documented on the CRF).

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Béatrice Cochener, Prof

Role: PRINCIPAL_INVESTIGATOR

Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis

Other Identifiers

PHY1902

Identifier Type: -

Identifier Source: org_study_id