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
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 3 years ago
What is this trial about?
What are the participation requirements?
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).