Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicentric Clinical Study to Determine Safety and Efficacy of a Hydrophobic Acrylic Trifocal Intraocular Lens (IOL)

Conditions
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Cataract, Lens Opacities

Intervention / Treatment
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* Device: Implantation of trifocal IOL, Isatis TF (device under investigation)
* Device: Implantation of monofocal IOL, Isatis (control device)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IOL implantation experimental<br>Experimental arm: Trifocal intraocular lens Isatis TF | Device: Implantation of trifocal IOL, Isatis TF (device under investigation)<br>* Patients will be implanted with study IOL in both eyes<br>|
| Active Comparator: IOL implantation active comparator<br>Comparator arm: Monofocal intraocular lens Isatis | Device: Implantation of monofocal IOL, Isatis (control device)<br>* Patients will be implanted with Control IOL in both eyes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint: Rates of Adverse Events | The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects. | 120-180 days postoperative | 
| Primary Performance Endpoint: Best Corrected Distance Visual Acuity | The primary performance endpoint is to show non inferiority of Isatis TF compared to the monofocal comparator in terms of best corrected distance visual acuity (CDVA) by means of statistical significance. | 120-180 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data | The objective is to compare best corrected distance visual acuities (CDVA) above defined thresholds of the investigational product to the normative data stated in the according ISO norm (EN ISO 11979-7:2018) for posterior chamber intraocular lenses. | 120-180 days postoperative | 
| Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA) | Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions on the first implanted eye. | 120-180 days postoperative | 
| Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA) | Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions on the first implanted eye. | 120-180 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOL, Intraocular Lens, hydrophobic, trifocal