An interventional study of Micropure 1.2.3. in Cataract and Lens Opacities, sponsored by Beaver-Visitec International, Inc.. Completed at 1 site in Belgium. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by Beaver-Visitec International, Inc. · Not applicable, Interventional, and Treatment
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Among 36 studies in Cataract by Beaver-Visitec International, Inc. — none open to participants now, 2 under way, none of them phase 3. Cataract · Beaver-Visitec International, Inc..
Among the 36 studies in Cataract by Beaver-Visitec International, Inc., this one is the 25th largest by enrollment of the 28 interventional ones that give a count, is one of 5 that started in 2018, is one of 28 with no phase, and was the 9th registered.
1,631 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →None of the 36 studies in Cataract by Beaver-Visitec International, Inc. is open now. The open studies under Cataract, anywhere →
Of the 142 Cataract studies recruiting now, 88 (62%) set no upper age limit and 8 (6%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.
This study: 45 Years and older · all sexes · healthy volunteers too.
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36 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 5 started in 2018.
This study's enrollment of 20 is below the median of 79 across 1,094 interventional studies indexed under Cataract.
Median enrollment 53 across the 28 interventional studies, 62 across the 8 observational. Of the 32 that completed or were terminated, 2 (6%) have results posted.
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Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 36 studies in Cataract by Beaver-Visitec International, Inc., from their registry updates:
Nothing recorded among them since 2026-09-25.
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Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." consisting of hydrophobic material
Device: Micropure 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 eye will be implanted
monocular Corrected Distance Visual Acuity (CDVA)
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.
Time frame: 3 months postoperative
Manifested refraction
The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2014.
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
UIVA is measured with ETDRS charts placed in 70cm distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
DCIVA is measured with ETDRS charts placed in 70cm distance and using best distance corrected refraction according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Binocular Corrected Distance Visual Acuity (CDVA)
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done binocularly
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Contrast Sensitivity under photopic and mesopic light conditions
Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular assessment of defocus curve under photopic light conditions
To assess the visual acuity for different distances, defocus curves under photopic light conditions will be measured. This test is performed with best distance corrected refraction and spherical additions ranging from -2.0 D to +1.5 D
Time frame: 1 month, 3 months, 12 months, 24 months postoperative
Slitlamp examination - Corneal status
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.
Time frame: 12 months, 24 months postoperative
Slitlamp examination - Fundus
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.
Time frame: 12 months, 24 months postoperative
Slitlamp examination - Signs of inflammation
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.
Time frame: 12 months, 24 months postoperative
Slitlamp examination - Pupillary block
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.
Time frame: 12 months, 24 months postoperative
Slitlamp examination - Retinal detachment
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.
Time frame: 12 months, 24 months postoperative
Slitlamp examination - Status of anterior and posterior capsule
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.
Time frame: 12 months, 24 months postoperative
Slitlamp examination - IOL decentration
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.
Time frame: 12 months, 24 months postoperative
Slitlamp examination IOL tilt
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.
Time frame: 12 months, 24 months postoperative
Slitlamp examination - IOL discoloration
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.
Time frame: 12 months, 24 months postoperative
Slitlamp examination - IOL opacity
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.
Time frame: 12 months, 24 months postoperative
Intraocular pressure (IOP) measurement
The IOP will be measured with non-contact tonometer as part of the routine follow up examinations
Time frame: Pre-operative, 1 month, 3 months, 12 months, 24 months postoperative
Questionnaire on IOL implantation
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.
Time frame: peroperative
Keratometry
Keratometric measurements are performed to calculate the required IOL power
Time frame: preoperative
Biometry
Biometry measurements are performed to calculate the required IOL power
Time frame: preoperative
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Jul 2021, 38 months.
Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's 38 months is above that.
Counting every sponsor, half of 493 studies reached it within 17 months; a quarter within 9 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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