Status:
WITHDRAWN
Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
Lead Sponsor:
Beaver-Visitec International, Inc.
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
45+ years
Phase:
NA
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 t...
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 u...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04054427
Start Date
November 1 2021
End Date
May 1 2022
Last Update
October 7 2021
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