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

Sponsored by Beaver-Visitec International, Inc.

About this trial

Last updated 4 years ago

Study ID

PHY1902

Status

Withdrawn

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
45+ Years
All
All

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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).