PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Spain

Study Overview
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Brief Summary
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This is a multicentric, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (study no. PHY2103)

Detailed Description
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This is a multicentric, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC. The device under investigation is a hydrophobic acrylic monofocal toric intraocular lens (IOL) manufactured by the sponsor of this study. The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be received an implantation with the monofocal parent lens PODEYE. The study purpose is to determine safety, rotational stability, refractive and visual performance, contrast sensitivity, patient satisfaction and PCO rate after mono- or bilateral implantation of PODEYE TORIC intraocular lens. In total approx. 45 patients will be recruited for this clinical study and undergo mono- or bilateral implantation of PODEYE TORIC intraocular lens. The maximum time between 1st and 2nd eye implantation is 30 days. Subjects participating in the trial will attend a total of maximum 12 study visits over a period of 630-780 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 days, 330-420 days and 630-780 days postoperative visits). Subjects would have the option for unscheduled visits if required medically.

Official Title
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Multicentric Post-market Clinical Follow-Up (PMCF) Study to Investigate Rotational Stability, Clinical Outcomes and Patient Reported Outcomes After Implantation of a Monofocal Toric IOL

Conditions
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Cataract, Lens Opacities, Astigmatism

Intervention / Treatment
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* Device: IOL implantation experimental


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults ages 50 years or older on the day of screening who have clinically documented cataracts in both eyes; Calculated IOL power (sphere and cylinder) is within the range of the investigational IOLs; Regular corneal astigmatism (measured by a topographer); Corneal astigmatism ≥0.75 D and ≤ 4.25 D (measured by an automatic keratometer) in one or both eyes; Capability to understand and sign an IRB approved informed consent form and privacy authorization; Clear intraocular media other than cataract; Dilated pupil size large enough to visualize IOL axis markings postoperatively; Best corrected visual acuity projected to be better than 0.2 logMAR after toric IOL implantation; Willing and able to conform to the study requirements. Exclusion Criteria: Age of patient <50 years at the day of screening; Regular corneal astigmatism <0.75 D or >4.25 D (measured by an automatic keratometer) in both eyes Irregular astigmatism (measured by a topographer); 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; Clinically significant, uncontrolled glaucoma with expected negative impact on Contrast Sensitivity and/or visual acuity outcomes; 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; Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study; Concurrent or previous (within 30 days) participation in another drug or device investigation; Clinically significant dry eye as determined by the investigator's judgement; Ocular surface disease (clinical symptoms or keratitis); Patients showing contraindications as listed in the current Instructions for use (IFU); Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF). 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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PODEYE TORIC IOL Implantation experimental<br>Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC | Device: IOL implantation experimental<br>* Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational stability - Photograph of IOL with dilated pupil to asses IOL rotation | The primary performance endpoint is to show statistically non-inferior rotational stability outcomes on PODEYE TORIC lens compared to CER data obtained for a multifocal toric IOL (POD FT) by the same manufacturer sharing the same haptic design but based on a hydrophilic lens material. The null hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is not larger than the absolute mean IOL rotation reported in the current CER on POD FT lens. The alternative hypothesis is that the absolute mean IOL rotation measured on PODEYE TORIC is larger than the outcomes reported in the current CER on POD FT lens. The measure is taken at 6 months postoperative visit compared to the measurement performed within 10 minutes after surgery. | 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Distance Visual Acuity compared to historical Data | The objective is to compare CDVA above defined thresholds of the investigational product to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.3 and E.4). The null hypothesis for the CDVA is that / when the true rate of cases with visual acuity 0.3 logMAR or better is less than or equal to the SPE rate. The alternative hypothesis is that the success rate is higher than the SPE rate. If the distance corrected visual acuity is 0.3 logMAR or better in 30 eyes or more (with 36 eyes included), the null hypothesis could be rejected, and the alternative hypothesis could be accepted. | Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative | 
| Change in cylindrical Power of the Eye | Change in cylindrical power, defined as the difference between magnitude of preoperative keratometric cylinder and postoperative manifest cylinder is calculated at every Form. The outcomes of this calculation will be stratified per 0.25D step of preoperative keratometric cylinder and descriptive statistics (mean, standard deviation, median, minimum, maximum) will be provided. | Pre-Op, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Lens, Monofocal, Toric Lens