Cataract, Lens Opacities
Conditions
Keywords
Intraocular lens, Monofocal, Hydrophobic
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.
Interventions
DEVICEMicropure 1.2.3.
Implantation of intraocular lens (IOL). Name: MicroPure 1.2.3. It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per patient will be implanted
DEVICEPODEYE
Implantation of intraocular lens (IOL). Name: PODEYE It is a monofocal intraocular lens consisting of hydrophobic acrylic material. The IOL will be implanted in the contralateral eye of the same patient already implanted with Micropure 1.2.3.
Sponsors
Beaver-Visitec International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| monocular Corrected Distance Visual Acuity (CDVA) | 6 months postoperative | Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to eyes implanted with the comparator PODEYE at the 6 months follow up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slitlamp examination - Corneal status | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Corneal status. |
| Slitlamp examination - IOL decentration | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL decentration. |
| Slitlamp examination IOL tilt | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL tilt. |
| Slitlamp examination - IOL discoloration | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL discoloration. |
| Slitlamp examination - IOL opacity | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL opacity. |
| Manifested refraction | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2018. |
| Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under photopic light conditions |
| Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions | preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions |
| Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under photopic light conditions |
| Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions | preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions |
| Monocular Contrast Sensitivity under photopic light conditions | 6 months postoperative | Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision) |
| Monocular Contrast Sensitivity under mesopic light conditions | 6 months postoperative | Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision) |
| Slitlamp examination - Fundus | preoperative, 12 months postoperative | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Fundus. |
| Slitlamp examination - Signs of inflammation | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Signs of inflammation. |
| Slitlamp examination - Pupillary block | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Pupillary block. |
| Slitlamp examination - Retinal detachment | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Retinal detachment. |
| Slitlamp examination - Status of anterior and posterior capsule | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Status of anterior and posterior capsule. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Keratometry | preoperative | Keratometric measurements are performed to calculate the required IOL power |
| Biometry | preoperative | Biometry measurements are performed to calculate the required IOL power |
| Questionnaire on IOL implantation | peroperative | A questionnaire will be handed out to the surgeon right after the surgery to document the ease of use and possible issues during IOL implantation. These data will be used to compare the outcomes to different surgery techniques or injectors. The questionnaire is not validated and the outcomes serve only for the sponsor to receive feedback if one or the other IOL is easier to implant. |
| Intraocular pressure (IOP) measurement | preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative | The IOP will be measured with non-contact tonometer as part of the routine follow up examinations |
Countries
Czechia
Outcome results
None listed