CataractNCT04054427
Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
A study testing IOL implantation experimental in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc..
Trial summary
Controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study to investigate visual performance after implantation of a trifocal IOL (PhysIOL Pod L GF) in patients that underwent refractive surgery. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Lens Opacities, Presbyopia
- What is being tested?
- IOL implantation experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cataracteous eyes with no comorbidity;
- Post LASIK, post PRK/surface ablation or post RK (radial keratotomy) patients with day of refractive surgery minimum 24 months before IOL implantation;
- Calculated IOL power is within the range of the study IOLs;
- Fulfill CHRU (Centre Hospitalier Regional Universitaire) internal criteria for multifocal lenses implantation on post-refractive surgery patients.
- Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes or suffer from presbyopia;
- Clear intraocular media other than cataract;
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
- Signed informed consent
Who cannot join
- Age of patient < 45 years;
- Irregular topographic examination where limitation in clinical outcomes are expected.
- Patients that underwent presbyopia correcting refractive surgery (e.g. PresbyLASIK, SUPRACOR, INTRACOR)
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
- Subjects with AMD suspicious eyes as determined by OCT examination;
- Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
Show all 13Show fewer
- Traumatic cataract;
- History or presence of macular edema;
- Concurrent or previous (within 30 days) participation in another drug or device investigation;
- Instability of keratometry or biometry measurements;
- Ocular hypertension or glaucoma;
- Significant dry eye;
- Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgement (reason to be documented on the CRF).
About this study
Official title: Clinical Study to Investigate Visual Performance and Patient Satisfaction After Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
Controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study to investigate visual performance after implantation of a trifocal IOL (PhysIOL Pod L GF) in patients that underwent refractive surgery.
Read the detailed description
This clinical investigation is a controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study whereby patients undergoing routine cataract surgery that previously underwent refractive surgery prior to being screened will have bilateral implantation of trifocal intraocular lens FineVision POD L GF (PhysIOL, Liège, Belgium).
The study purpose is to collect clinical data on visual acuity, contrast sensitivity and patient reported outcomes obtained on patients with cataracts and/or suffering from presbyopia that underwent refractive surgery prior to the IOL implantation.
The device under investigation (FineVision POD L GF) is a trifocal 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 28 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD L GF intraocular lens.
Subjects participating in the trial will attend a total of 9 study visits (1 preoperative, 2 operative and 6 postoperative) over a period of 6 months.
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Being tested
- IOL implantation experimental
- Keywords
- Intraocular Lens, Trifocal, hydrophobic, Post refractive surgery
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL implantation experimentalDevice
Implantation of trifocal IOL POD L GF consisting of hydrophobic material
| Study group | Role | What they receive |
|---|---|---|
| IOL implantation experimental | Experimental | hydrophobic, trifocal intraocular lens POD L GF Receives: Device: IOL implantation experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular Best Corrected Distance Visual Acuity (CDVA)
Statistically significant non-inferiority with POD L GF on monocular CDVA in comparison to literature data. A significance level of 0.05 will be considered statistically significant.
Measured: 6 months (120-180 days) postoperative
Secondary outcomes (38)
Manifest refraction (sphere and cylinder)
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
Measured: Pre-OP, 1-2 days post operative, 30-60 days postoperative, 120-180 days postoperative
Pupil Size Photopic
Photopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the photopic pupil diameters, eye illumination should be identical to that used for photopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).
Measured: 120-180 days postoperative
Pupil Size Mesopic
Mesopic pupil diameters are measured with a precision of at least +/-0.5 mm. For the mesopic pupil diameters, eye illumination should be identical to that used for mesopic contrast sensitivity testing. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).
Measured: 120-180 days postoperative
Uncorrected Distance Visual Acuity (UDVA) - monocular
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
Measured: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Distance Visual Acuity (UDVA) - binocular
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Measured: 120-180 days postoperative
Corrected Distance Visual Acuity (CDVA) - monocular
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 monocularly under photopic conditions.
Measured: Pre-OP, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Corrected Distance Visual Acuity (CDVA) - binocular
Monocular and Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic and mesopic light conditions at 80cm distance
Measured: 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - monocular
UIVA is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Measured: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - binocular
UIVA is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Measured: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular
DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Measured: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - binocular
DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Measured: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular mesopic
DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
Measured: 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - monocular
UIVA is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Measured: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - binocular
UIVA is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Measured: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular
DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.
Measured: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - binocular
DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.
Measured: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular mesopic.
DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
Measured: 120-180 days postoperative
Uncorrected Near Visual Acuity at 40cm (UNVA) - monocular
UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
Measured: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Near Visual Acuity at 40cm (UNVA) - binocular
UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions
Measured: 120-180 days postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular
DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions
Measured: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - binocular
DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions
Measured: 120-180 days postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular mesopic
DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions
Measured: 120-180 days postoperative
Defocus Curve
To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -4.0 D to +2.0 D. This examination is performed binocularly
Measured: 120-180 days postoperative
Binocular Contrast Sensitivity under photopic light conditions
Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Measured: 120-180 days postoperative
Binocular Contrast Sensitivity under mesopic light conditions
Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Measured: 120-180 days postoperative
Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
Contrast Sensitivity under mesopic light conditions with a glare source using the standardized contrast sensitivity device Clinical Trial Suite (M\&S Technologies). This examination is performed binocularly.
Measured: 120-180 days postoperative
Patient reported outcomes: Quality of Vision Questionnaire (QoV) quality of vision
Quality of vision based on response to each question in the Quality of Vision (QoV) questionnaire. Answer is a choice of 4 options, the first being the least and the fourth being the most based on question type, i.e. "never" to "very often" or "not at all" to "severe".
Measured: 120-180 days postoperative
Patient reported outcomes: Near Activity Visual Questionnaire (NAVQ) quality of vision
Quality of vision based on response (choice of 0-3 with 0 meaning no difficulty and 3 meaning extreme difficulty) to each question in the Near Activity Visual Questionnaire (NAVQ)
Measured: 120-180 days postoperative
Slit lamp 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
Measured: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Fundus examination with dilated pupil
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
Measured: Pre Op, 120-180 days postoperative
Slit lamp 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 Anterior chamber cells, Anterior chamber flare, Cystoid macular oedema, Hypopyon, and Endophthalmitis
Measured: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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
Measured: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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
Measured: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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
Measured: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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
Measured: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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
Measured: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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
Measured: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp 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
Measured: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study startNov 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: Did not start study due to EC board rejection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Béatrice Cochener, Prof, Principal investigator, Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054427
- Sponsor's protocol ID
- PHY1902
- Status last verified
- Sep 2021
- First submitted
- 8 Aug 2019
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Investigate Visual Performance and Patient Satisfaction After Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
- ClinicalTrials.gov ID
- NCT04054427
- Acronym / sponsor ID
- PHY1902
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Keywords
- Intraocular Lens, Trifocal, hydrophobic, Post refractive surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not start study due to EC board rejection
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study to investigate visual performance after implantation of a trifocal IOL (PhysIOL Pod L GF) in patients that underwent refractive surgery.
Detailed description
This clinical investigation is a controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study whereby patients undergoing routine cataract surgery that previously underwent refractive surgery prior to being screened will have bilateral implantation of trifocal intraocular lens FineVision POD L GF (PhysIOL, Liège, Belgium).
The study purpose is to collect clinical data on visual acuity, contrast sensitivity and patient reported outcomes obtained on patients with cataracts and/or suffering from presbyopia that underwent refractive surgery prior to the IOL implantation.
The device under investigation (FineVision POD L GF) is a trifocal 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 28 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD L GF intraocular lens.
Subjects participating in the trial will attend a total of 9 study visits (1 preoperative, 2 operative and 6 postoperative) over a period of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOL implantation experimental | Experimental | Device: IOL implantation experimentalhydrophobic, trifocal intraocular lens POD L GF |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cataracteous eyes with no comorbidity;
- Post LASIK, post PRK/surface ablation or post RK (radial keratotomy) patients with day of refractive surgery minimum 24 months before IOL implantation;
- Calculated IOL power is within the range of the study IOLs;
- Fulfill CHRU (Centre Hospitalier Regional Universitaire) internal criteria for multifocal lenses implantation on post-refractive surgery patients.
- Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes or suffer from presbyopia;
Key exclusion criteria (13 listed)
- Age of patient < 45 years;
- Irregular topographic examination where limitation in clinical outcomes are expected.
- Patients that underwent presbyopia correcting refractive surgery (e.g. PresbyLASIK, SUPRACOR, INTRACOR)
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
- Subjects with AMD suspicious eyes as determined by OCT examination;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOL implantation experimentalImplantation of trifocal IOL POD L GF consisting of hydrophobic material | Device | IOL implantation experimental |
Primary outcome
Monocular Best Corrected Distance Visual Acuity (CDVA)
Time frame: 6 months (120-180 days) postoperative
Statistically significant non-inferiority with POD L GF on monocular CDVA in comparison to literature data. A significance level of 0.05 will be considered statistically significant.
38 secondary outcomes
Manifest refraction (sphere and cylinder)
Time frame: Pre-OP, 1-2 days post operative, 30-60 days postoperative, 120-180 days postoperative
Pupil Size Photopic
Time frame: 120-180 days postoperative
Pupil Size Mesopic
Time frame: 120-180 days postoperative
Uncorrected Distance Visual Acuity (UDVA) - monocular
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Distance Visual Acuity (UDVA) - binocular
Time frame: 120-180 days postoperative
Corrected Distance Visual Acuity (CDVA) - monocular
Time frame: Pre-OP, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Corrected Distance Visual Acuity (CDVA) - binocular
Time frame: 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - monocular
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - binocular
Time frame: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - binocular
Time frame: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular mesopic
Time frame: 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - monocular
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - binocular
Time frame: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - binocular
Time frame: 120-180 days postoperative
Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular mesopic.
Time frame: 120-180 days postoperative
Uncorrected Near Visual Acuity at 40cm (UNVA) - monocular
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Uncorrected Near Visual Acuity at 40cm (UNVA) - binocular
Time frame: 120-180 days postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular
Time frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - binocular
Time frame: 120-180 days postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular mesopic
Time frame: 120-180 days postoperative
Defocus Curve
Time frame: 120-180 days postoperative
Binocular Contrast Sensitivity under photopic light conditions
Time frame: 120-180 days postoperative
Binocular Contrast Sensitivity under mesopic light conditions
Time frame: 120-180 days postoperative
Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
Time frame: 120-180 days postoperative
Patient reported outcomes: Quality of Vision Questionnaire (QoV) quality of vision
Time frame: 120-180 days postoperative
Patient reported outcomes: Near Activity Visual Questionnaire (NAVQ) quality of vision
Time frame: 120-180 days postoperative
Slit lamp examination - Corneal Status
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Fundus examination with dilated pupil
Time frame: Pre Op, 120-180 days postoperative
Slit lamp examination - Signs of inflammation
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp examination - Pupillary block
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp examination - Retinal detachment
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp examination - Status of anterior and posterior capsule
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp examination - IOL decentration
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp examination - IOL tilt
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp examination - IOL discoloration
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Slit lamp examination - IOL opacity
Time frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Béatrice Cochener, Prof principal investigator
Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis
Questions about this trial
What is this clinical trial studying?
A study testing IOL implantation experimental in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular Best Corrected Distance Visual Acuity (CDVA) (time frame: 6 months (120-180 days) postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.