Clinical trial NCT04249492: PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL
Official title: Multicentric Post-Market Clinical Follow-up (PMCF) Investigation to Determine Safety and Efficacy of a Hydrophobic EDOF Intraocular Lens (IOL) in Comparison to a Monofocal IOL
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cataract
Lens Opacities
Keywords: Intraocular Lens
EDOF
hydrophobic
IOL
monofocal
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: targomedGmbH
First posted: 2020-01-31
Enrollment: 244
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of an enhanced depth of focus (EDOF) IOL with the outcomes obtained with a monofocal lens. Implantation of the IOLs is bilaterally.

Detailed description: This is a multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of Enhanced Depth of Focus intraocular lenses (Isopure 1.2.3.) or monofocal lenses (Micropure 1.2.3.). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation is being carried out. The investigational device and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.

The study will be carried out in up to five clinical centers in Europe and Asia.

The device under investigation (Isopure 1.2.3.) is a hydrophobic, glistening-free, acrylic EDOF intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens is the parent IOL, belonging to the same IOL family of this manufacturer. It is a hydrophobic, glistening-free, acrylic monofocal IOL (Micropure 1.2.3.). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of maximum 11 study visits (1 preoperative, 1 or 2 operative and up to 8 postoperative) over a period of 12 months. If local requirements allow, preoperative and operative visit can be done on the same day. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 120-180 days follow up visit. Secondary endpoint data will be collected at the 330-420 days follow up visit. Data interim analyses will be done after the last patient finished the 120-180 days postoperative examination to support the study publication plan.

Eligibility criteria: Inclusion Criteria:

* Cataractous eyes with no comorbidity;
* Calculated IOL power is within the range of the study IOLs;
* Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes;
* Regular corneal astigmatism ≤1.0 D (measured by an automatic keratometer)
* Clear intraocular media other than cataract;
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
* Signed informed consent.

Exclusion Criteria:

* Age of patient \< 45 years;
* Regular corneal astigmatism \>1.0 dioptres (measured by an automatic keratometer)
* Irregular astigmatism;
* Difficulty for cooperation (distance from their home, general health conditions);
* 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;
* Previous intraocular or corneal surgery;
* Traumatic cataract;
* History or presence of macular edema;
* Instability of keratometry or biometry measurements;
* Ocular hypertension or glaucoma;
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
* Expected complicated surgery;
* Significant dry eye.

Primary outcomes:
measure: monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
timeFrame: 6 months (120-180 days) postoperative
Secondary outcomes:
measure: Manifested refraction
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Monocular Corrected Distance Visual Acuity (low contrast CDVA) using low contrast (10%) optotypes under photopic light conditions
timeFrame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Monocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition
timeFrame: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Binocular Uncorrected Intermediate Visual Acuity at 80cm (UIVA@80cm) under photopic light condition
timeFrame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Monocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions
timeFrame: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Binocular Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA@80cm) under photopic light conditions
timeFrame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Monocular Distance Corrected Distance Visual Acuity at 80cm (low contrast DCIVA@80cm) using low contrast (10%) optotypes under photopic light conditions
timeFrame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Monocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition
timeFrame: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under photopic light condition
timeFrame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Monocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions
timeFrame: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions
timeFrame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Monocular Distance Corrected Distance Visual Acuity at 66cm (low contrast DCIVA@66cm) using low contrast (10%) optotypes under photopic light conditions
timeFrame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
measure: Binocular Distance Corrected Near Visual Acuity at 40cm (DCNVA) under photopic light conditions
timeFrame: 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Monocular Defocus Curve
timeFrame: 1 month (30-60 days) postoperative
measure: Binocular Defocus Curve
timeFrame: 6 months (120-180 days) postoperative
measure: Binocular Contrast Sensitivity under photopic light conditions
timeFrame: 6 months (120-180 days) postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions
timeFrame: 6 months (120-180 days) postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
timeFrame: 6 months (120-180 days) postoperative
measure: Halo and Glare Simulator
timeFrame: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010]
timeFrame: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Patient reported outcomes - Catquest-9SF 2011 questionnaire [Lundström et al, 2009]
timeFrame: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]
timeFrame: preoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Aberrometry
timeFrame: preoperative, 6 months (120-180 days) postoperative
measure: Pupil Size under photopic light conditions
timeFrame: preoperative, 6 months (120-180 days) postoperative
measure: Pupil Size under mesopic light conditions
timeFrame: preoperative, 6 months (120-180 days) postoperative
measure: Fundus examination with dilated pupil
timeFrame: preoperative, 12 months (330-420 days) postoperative
measure: Slitlamp examination - Corneal status
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Slitlamp examination - Signs of inflammation
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Slitlamp examination - Pupillary block
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Slitlamp examination - Retinal detachment
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Slitlamp examination - Status of anterior and posterior capsule
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Slitlamp examination - IOL decentration
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Slitlamp examination - IOL tilt
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Slitlamp examination - IOL discoloration
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Slitlamp examination - IOL opacity
timeFrame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Other outcomes:
measure: Intraocular pressure (IOP) measurement
timeFrame: Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
measure: Keratometry
timeFrame: Preoperative
measure: IOL power and target refraction
timeFrame: Operative (day of surgery)
measure: Fundus OCT
timeFrame: Preoperative, 1 month (30-60 days) postoperative
Locations:
city: Vienna
country: Austria
facility: Hanusch Krankenhaus
city: Zlín
country: Czechia
facility: Gemini Eye Clinic
city: Ahaus
country: Germany
facility: Augen-Zentrum-Nordwest
city: Heidelberg
country: Germany
facility: Universitäts-Augenklinik Heidelberg
city: Leipzig
country: Germany
facility: Smile Eyes Augen + Laserzentrum
city: Rheine
country: Germany
facility: Augentagesklinik Rheine
city: Kildare
country: Ireland
facility: Institute of Eye Surgery - Clane
city: Waterford
country: Ireland
facility: Institute of Eye Surgery
city: Makati City
country: Philippines
facility: Asian Eye Institute
city: Alicante
country: Spain
facility: Oftalvist Alicante
city: Madrid
country: Spain
facility: Miranza IOA Madrid
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: Augentagesklinik Rheine
name: Florian Kretz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
citation: Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.
citation: Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.