Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- monocular Corrected Distance Visual Acuity (CDVA)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Arm: Investigational Device
Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." consisting of hydrophobic material
Intervention: Micropure 1.2.3. (Device)
Outcomes
Primary Outcomes
monocular Corrected Distance Visual Acuity (CDVA)
Time Frame: 3 months postoperative
Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to literature data on a monofocal hydrophilic IOL (Bausch \& Lomb - Akreos MI60) at the 3 months follow up visit.
Secondary Outcomes
- Manifested refraction(1 month, 3 months, 12 months, 24 months postoperative)
- Binocular Corrected Distance Visual Acuity (CDVA)(1 month, 3 months, 12 months, 24 months postoperative)
- Monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)(1 month, 3 months, 12 months, 24 months postoperative)
- Monocular and binocular Contrast Sensitivity under photopic and mesopic light conditions(1 month, 3 months, 12 months, 24 months postoperative)
- Slitlamp examination - Retinal detachment(12 months, 24 months postoperative)
- Monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)(1 month, 3 months, 12 months, 24 months postoperative)
- Monocular and binocular assessment of defocus curve under photopic light conditions(1 month, 3 months, 12 months, 24 months postoperative)
- Slitlamp examination - Corneal status(12 months, 24 months postoperative)
- Slitlamp examination - Fundus(12 months, 24 months postoperative)
- Slitlamp examination - Status of anterior and posterior capsule(12 months, 24 months postoperative)
- Monocular and binocular Uncorrected Distance Visual Acuity (UDVA)(1 month, 3 months, 12 months, 24 months postoperative)
- Slitlamp examination - Signs of inflammation(12 months, 24 months postoperative)
- Slitlamp examination IOL tilt(12 months, 24 months postoperative)
- Slitlamp examination - IOL discoloration(12 months, 24 months postoperative)
- Slitlamp examination - Pupillary block(12 months, 24 months postoperative)
- Slitlamp examination - IOL opacity(12 months, 24 months postoperative)
- Slitlamp examination - IOL decentration(12 months, 24 months postoperative)