Clinical Study to Investigate Visual Performance and Patient Satisfaction After Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery

Beaver-Visitec International, Inc.0 sitesNovember 2021

ConditionsCataract Lens Opacities Presbyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Beaver-Visitec International, Inc.
Primary Endpoint: Monocular Best Corrected Distance Visual Acuity (CDVA)
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2021

End Date

May 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beaver-Visitec International, Inc.

Responsible Party

Sponsor

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;

Outcomes

Primary Outcomes

Monocular Best Corrected Distance Visual Acuity (CDVA)

Time Frame: 6 months (120-180 days) postoperative

Statistically significant non-inferiority with POD L GF on monocular CDVA in comparison to literature data. A significance level of 0.05 will be considered statistically significant.

Secondary Outcomes

Pupil Size Photopic(120-180 days postoperative)
Uncorrected Distance Visual Acuity (UDVA) - monocular(Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)
Manifest refraction (sphere and cylinder)(Pre-OP, 1-2 days post operative, 30-60 days postoperative, 120-180 days postoperative)
Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - binocular(120-180 days postoperative)
Uncorrected Distance Visual Acuity (UDVA) - binocular(120-180 days postoperative)
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - binocular(120-180 days postoperative)
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular mesopic.(120-180 days postoperative)
Binocular Contrast Sensitivity under mesopic light conditions(120-180 days postoperative)
Patient reported outcomes: Quality of Vision Questionnaire (QoV) quality of vision(120-180 days postoperative)
Pupil Size Mesopic(120-180 days postoperative)
Corrected Distance Visual Acuity (CDVA) - binocular(120-180 days postoperative)
Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - monocular(7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative)
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular mesopic(120-180 days postoperative)
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - binocular(120-180 days postoperative)
Uncorrected Near Visual Acuity at 40cm (UNVA) - monocular(7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative)
Uncorrected Near Visual Acuity at 40cm (UNVA) - binocular(120-180 days postoperative)
Slit lamp examination - Signs of inflammation(Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)
Slit lamp examination - Status of anterior and posterior capsule(Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)
Corrected Distance Visual Acuity (CDVA) - monocular(Pre-OP, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular(7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative)
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - binocular(120-180 days postoperative)
Defocus Curve(120-180 days postoperative)
Binocular Contrast Sensitivity under photopic light conditions(120-180 days postoperative)
Patient reported outcomes: Near Activity Visual Questionnaire (NAVQ) quality of vision(120-180 days postoperative)
Fundus examination with dilated pupil(Pre Op, 120-180 days postoperative)
Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - monocular(7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative)
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular(7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative)
Slit lamp examination - Retinal detachment(Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)
Slit lamp examination - IOL decentration(Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)
Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - binocular(120-180 days postoperative)
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular(7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative)
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular mesopic(120-180 days postoperative)
Binocular Contrast Sensitivity under mesopic light conditions and using a glare source(120-180 days postoperative)
Slit lamp examination - Corneal Status(Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)
Slit lamp examination - Pupillary block(Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)
Slit lamp examination - IOL tilt(Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)
Slit lamp examination - IOL discoloration(Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)
Slit lamp examination - IOL opacity(Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative)