Clinical trial NCT03796624: Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses
Official title: Comparison of Clinical Outcomes After Implantation of MICROPURE (PhysIOL) and PodEye (PhysIOL) Monofocal Intraocular Lenses Into the Two Eyes of the Same Patient
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: 2019-01-08
Enrollment: 76
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
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. and PODEYE intraocular lenses.

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 implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in the contralateral eye of the same patient.

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

The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference is the mechanical design of the haptics, that is not expected to have an influence on the clinical outcomes.

The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 76 patients will be recruited for this clinical study and receive the implantation of Micropure 1.2.3. and POPDEYE intraocular lenses.

Subjects participating in the trial will attend study visits over a period of 12 months.

Eligibility criteria: Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Clear intraocular media other than cataract;
* Signed informed consent

Exclusion Criteria:

* Age of patient \< 45 years;
* Irregular astigmatism;
* 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);
* Previous intraocular or corneal surgery;
* Traumatic cataract;
* Any ocular comorbidity;
* Instability of keratometry or biometry measurements.

Primary outcomes:
measure: monocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 6 months postoperative
Secondary outcomes:
measure: Manifested refraction
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
timeFrame: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
timeFrame: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Monocular Contrast Sensitivity under photopic light conditions
timeFrame: 6 months postoperative
measure: Monocular Contrast Sensitivity under mesopic light conditions
timeFrame: 6 months postoperative
measure: Slitlamp examination - Corneal status
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - Fundus
timeFrame: preoperative, 12 months postoperative
measure: Slitlamp examination - Signs of inflammation
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - Pupillary block
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - Retinal detachment
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - Status of anterior and posterior capsule
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - IOL decentration
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination IOL tilt
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - IOL discoloration
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Slitlamp examination - IOL opacity
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Other outcomes:
measure: Intraocular pressure (IOP) measurement
timeFrame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
measure: Questionnaire on IOL implantation
timeFrame: peroperative
measure: Keratometry
timeFrame: preoperative
measure: Biometry
timeFrame: preoperative
Locations:
city: Zlin
country: Czechia
facility: GEMINI Eye Clinic
Study officials:
affiliation: Gemini Eye Clinic
name: Pavel Stodůlka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: