Clinical trial NCT04054427: Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
Official title: Clinical Study to Investigate Visual Performance and Patient Satisfaction After Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cataract
Lens Opacities
Presbyopia
Keywords: Intraocular Lens
Trifocal
hydrophobic
Post refractive surgery
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Monocular Best Corrected Distance Visual Acuity (CDVA)
timeFrame: 6 months (120-180 days) postoperative
Secondary outcomes:
measure: Manifest refraction (sphere and cylinder)
timeFrame: Pre-OP, 1-2 days post operative, 30-60 days postoperative, 120-180 days postoperative
measure: Pupil Size Photopic
timeFrame: 120-180 days postoperative
measure: Pupil Size Mesopic
timeFrame: 120-180 days postoperative
measure: Uncorrected Distance Visual Acuity (UDVA) - monocular
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Uncorrected Distance Visual Acuity (UDVA) - binocular
timeFrame: 120-180 days postoperative
measure: Corrected Distance Visual Acuity (CDVA) - monocular
timeFrame: Pre-OP, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Corrected Distance Visual Acuity (CDVA) - binocular
timeFrame: 120-180 days postoperative
measure: Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - monocular
timeFrame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
measure: Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - binocular
timeFrame: 120-180 days postoperative
measure: Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular
timeFrame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
measure: Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - binocular
timeFrame: 120-180 days postoperative
measure: Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular mesopic
timeFrame: 120-180 days postoperative
measure: Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - monocular
timeFrame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
measure: Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - binocular
timeFrame: 120-180 days postoperative
measure: Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular
timeFrame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
measure: Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - binocular
timeFrame: 120-180 days postoperative
measure: Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular mesopic.
timeFrame: 120-180 days postoperative
measure: Uncorrected Near Visual Acuity at 40cm (UNVA) - monocular
timeFrame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
measure: Uncorrected Near Visual Acuity at 40cm (UNVA) - binocular
timeFrame: 120-180 days postoperative
measure: Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular
timeFrame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
measure: Distance Corrected Near Visual Acuity at 40cm (DCNVA) - binocular
timeFrame: 120-180 days postoperative
measure: Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular mesopic
timeFrame: 120-180 days postoperative
measure: Defocus Curve
timeFrame: 120-180 days postoperative
measure: Binocular Contrast Sensitivity under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
timeFrame: 120-180 days postoperative
measure: Patient reported outcomes: Quality of Vision Questionnaire (QoV) quality of vision
timeFrame: 120-180 days postoperative
measure: Patient reported outcomes: Near Activity Visual Questionnaire (NAVQ) quality of vision
timeFrame: 120-180 days postoperative
measure: Slit lamp examination - Corneal Status
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Fundus examination with dilated pupil
timeFrame: Pre Op, 120-180 days postoperative
measure: Slit lamp examination - Signs of inflammation
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slit lamp examination - Pupillary block
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slit lamp examination - Retinal detachment
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slit lamp examination - Status of anterior and posterior capsule
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slit lamp examination - IOL decentration
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slit lamp examination - IOL tilt
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slit lamp examination - IOL discoloration
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slit lamp examination - IOL opacity
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Other outcomes:
measure: Intraocular pressure (IOP) measurement
timeFrame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Keratometry
timeFrame: Pre-OP
measure: Biometry
timeFrame: Pre-OP
measure: IOL power and target refraction
timeFrame: Operative (day of Surgery)
measure: Fundus OCT
timeFrame: Pre-OP
Locations:
Study officials:
affiliation: Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis
name: Béatrice Cochener, Prof
role: PRINCIPAL_INVESTIGATOR
References: