Clinical trial NCT03423524: Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation
Official title: Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Keywords: Intraocular lens
Monofocal
Hydrophobic
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-06
Enrollment: 20
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: Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.

Detailed description: This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have bilateral implantation of monofocal intraocular lenses Micropure 1.2.3. (PhysIOL, Liège, Belgium)

The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3.

The device under investigation (Micropure 1.2.3.) is a monofocal 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 50 patients will be recruited for this clinical study and receive a bilateral implantation of Micropure 1.2.3. intraocular lens.

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 2 Years.

Eligibility criteria: Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Irregular astigmatism
* Age of patient \< 45 years
* Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* Complicated surgery
* Patients who do not give informed consent

Primary outcomes:
measure: monocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Manifested refraction
timeFrame: 1 month, 3 months, 12 months, 24 months postoperative
measure: Monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 1 month, 3 months, 12 months, 24 months postoperative
measure: Monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: 1 month, 3 months, 12 months, 24 months postoperative
measure: Monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
timeFrame: 1 month, 3 months, 12 months, 24 months postoperative
measure: Binocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 1 month, 3 months, 12 months, 24 months postoperative
measure: Monocular and binocular Contrast Sensitivity under photopic and mesopic light conditions
timeFrame: 1 month, 3 months, 12 months, 24 months postoperative
measure: Monocular and binocular assessment of defocus curve under photopic light conditions
timeFrame: 1 month, 3 months, 12 months, 24 months postoperative
measure: Slitlamp examination - Corneal status
timeFrame: 12 months, 24 months postoperative
measure: Slitlamp examination - Fundus
timeFrame: 12 months, 24 months postoperative
measure: Slitlamp examination - Signs of inflammation
timeFrame: 12 months, 24 months postoperative
measure: Slitlamp examination - Pupillary block
timeFrame: 12 months, 24 months postoperative
measure: Slitlamp examination - Retinal detachment
timeFrame: 12 months, 24 months postoperative
measure: Slitlamp examination - Status of anterior and posterior capsule
timeFrame: 12 months, 24 months postoperative
measure: Slitlamp examination - IOL decentration
timeFrame: 12 months, 24 months postoperative
measure: Slitlamp examination IOL tilt
timeFrame: 12 months, 24 months postoperative
measure: Slitlamp examination - IOL discoloration
timeFrame: 12 months, 24 months postoperative
measure: Slitlamp examination - IOL opacity
timeFrame: 12 months, 24 months postoperative
Other outcomes:
measure: Intraocular pressure (IOP) measurement
timeFrame: Pre-operative, 1 month, 3 months, 12 months, 24 months postoperative
measure: Questionnaire on IOL implantation
timeFrame: peroperative
measure: Keratometry
timeFrame: preoperative
measure: Biometry
timeFrame: preoperative
Locations:
city: Liège
country: Belgium
facility: Ophtalmology department - CHU liège
Study officials:
affiliation: Ophtalmology department - CHU liège
name: Francoise Van Cauwenberge, MD
role: PRINCIPAL_INVESTIGATOR
References: