Clinical trial NCT04465344: Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens
Official title: Multicentric Clinical Study to Determine Safety and Efficacy of a Hydrophobic Acrylic Trifocal Intraocular Lens (IOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Keywords: Intraocular Lens
IOL
hydrophobic
trifocal
Lead sponsor: Cutting Edge SAS
Sponsor class: INDUSTRY
Collaborators: name: targomedGmbH
First posted: 2020-07-10
Enrollment: 188
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.

Detailed description: This is a staged, multicentric, controlled, prospective, open-label clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic acrylic refractive trifocal intraocular lenses (Isatis TF) or the monofocal control device Isatis.

The investigational device, Control lens 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 Spain.

The device under investigation is a hydrophobic acrylic trifocal intraocular lens (IOL) manufactured by the sponsor of this study. The trifocality of this investigational device is based on a purely refractive principle with the goal to provide additional near and intermediate visual acuity with low photic side effects. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development.

The control device (Isatis) is a hydrophobic acrylic monofocal intraocular lens to be implanted during cataract surgery. This control lens is CE approved and commercially available in Spain. Isatis monofocal lens is the parent lens of the device under investigation and both lenses share mechanical and material properties.

In total 180 patients will be recruited for this clinical study and undergo bilateral implantation of the Isatis TF intraocular lens or Isatis lens in a 2:1 ratio. Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 11-13 months. Subjects would have the option for unscheduled visits if required medically.

Data analyses will be performed after the last patient finished the 120-180 days postoperative examination.

Eligibility criteria: Inclusion Criteria:

* Clinically documented age-related cataract in both eyes with no comorbidity;
* Calculated IOL power is within the range of the investigational IOLs;
* Male or female adults ages 50 years or older on the day of screening who have cataracts in both eyes;
* Regular corneal astigmatism (measured by topographer)
* 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;
* Patient is willing to receive bilateral implantation of a trifocal IOL (this inclusion criteria applies only to the study group, not the control group);
* Signed informed consent.

Exclusion Criteria:

* Age of patient \< 50 years;
* Regular corneal astigmatism \>1.0 dioptres (measured by an automatic keratometer)
* Irregular astigmatism (measured by topographer);
* 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);
* Subjects with AMD suspicious eyes as determined by OCT examination;
* Previous intraocular or corneal surgery;
* Traumatic cataract;
* Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
* Ocular hypertension, suspicious glaucoma or glaucoma;
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
* Expected complicated surgery;
* Ocular surface disease (clinical symptoms or keratitis);
* Pregnancy or lactation;
* Second eye treatment will only be performed when Best Corrected Distance Visual Acuity (CDVA) of first eye is ≤ 0.2 logMAR (≥ 0.63 decimal);
* Concurrent participation in another drug or device investigation.

In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:

* zonular instability;
* need for iris manipulation;
* capsular fibrosis or other opacity; and
* inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.

Primary outcomes:
measure: Primary Safety Endpoint: Rates of Adverse Events
timeFrame: 120-180 days postoperative
measure: Primary Performance Endpoint: Best Corrected Distance Visual Acuity
timeFrame: 120-180 days postoperative
Secondary outcomes:
measure: Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
timeFrame: 120-180 days postoperative
measure: Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)
timeFrame: 120-180 days postoperative
measure: Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)
timeFrame: 120-180 days postoperative
Other outcomes:
measure: Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: Preoperative, 1-2 days postoperative; 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: 120-180 days postoperative, 330-420 days postoperative
measure: Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Monocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions
timeFrame: 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Binocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions
timeFrame: 120-180 days postoperative, 330-420 days postoperative
measure: Monocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions
timeFrame: 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Binocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions
timeFrame: 120-180 days postoperative, 330-420 days postoperative
measure: Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions
timeFrame: Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under mesopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions
timeFrame: Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Monocular Distance Corrected Near Visual Acuity (DCNVA) under mesopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Manifest refraction
timeFrame: Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Adjusted Mean Refractive Spherical Equivalent (MRSE)
timeFrame: 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Binocular Defocus Curve
timeFrame: 120-180 days postoperative
measure: Binocular Contrast Sensitivity under photopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions
timeFrame: 120-180 days postoperative
measure: Binocular Contrast Sensitivity under photopic light conditions and using a glare source
timeFrame: 120-180 days postoperative
measure: Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
timeFrame: 120-180 days postoperative
measure: Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010]
timeFrame: preoperative, 120-180 days postoperative
measure: Patient reported outcomes - Catquest-9SF 2011 questionnaire [Lundström et al, 2009]
timeFrame: preoperative, 120-180 days postoperative
measure: Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]
timeFrame: preoperative, 120-180 days postoperative
measure: Pupil Size under photopic light conditions
timeFrame: preoperative, 120-180 days postoperative
measure: Pupil Size under mesopic light conditions
timeFrame: preoperative, 120-180 days postoperative
measure: Fundus examination with dilated pupil
timeFrame: preoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Slitlamp examination - Corneal status
timeFrame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Slitlamp examination - Iris status
timeFrame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Slitlamp examination - Signs of inflammation
timeFrame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Slitlamp examination - Pupillary block
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Slitlamp examination - Retinal detachment
timeFrame: preoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Slitlamp examination - Status of anterior and posterior capsule
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Slitlamp examination - IOL decentration
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Slitlamp examination - IOL tilt
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Slitlamp examination - IOL discoloration
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Slitlamp examination - IOL opacity
timeFrame: 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Intraocular pressure (IOP) measurement
timeFrame: Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
measure: Keratometry
timeFrame: Preoperative
measure: IOL power and target refraction
timeFrame: day of surgery
measure: Fundus OCT
timeFrame: Preoperative
measure: Biometry
timeFrame: Preoperative
measure: Corneal topography
timeFrame: Preoperative
measure: Corneal aberrometry
timeFrame: Preoperative
measure: IOL rotation
timeFrame: day of surgery, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
measure: Halo and glare scores
timeFrame: Preoperative, 120-180 days postoperative, 330-420 days postoperative
Locations:
city: Ostrava
country: Czechia
facility: Gemini Eye Clinic Ostrava
city: Praha
country: Czechia
facility: Gemini Eye Clinic Praha-Krc
city: Zlín
country: Czechia
facility: Gemini Eye Clinic Zlín
city: Donostia San Sebastian
country: Spain
facility: Hospital Donostia
city: Madrid
country: Spain
facility: Oftalvist Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
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.