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

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.

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.

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.

The IOP will be measured with non-contact tonometer as part of the routine follow up examinations. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

Keratometric measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

Biometry measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

The power of the implanted IOL must be recorded.

The target refraction given by the IOL calculator is documented. This parameter is needed to calculate the accuracy of achieving the target refraction. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

An OCT (optical coherence tomography) image will be taken at the preoperative visit to identify AMD suspicious eyes that need to be excluded from this study. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

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).

The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

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).

The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2018.

UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.

UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions.

UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.

UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under mesopic conditions.

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.

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 mesopic conditions.

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 binocularly under photopic conditions.

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 binocularly under mesopic conditions.

Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.

Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.

Contrast Sensitivity under photopic light conditions with a glare source using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.

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.

Outcomes measures of a questionnaire to address subjective study outcomes and disturbance by photic phenomena. For this study, the validated and verified questionnaire Quality of Vision (QoV) will be used.

The QoV Questionnaire consists of a Rasch-tested, linear-scaled, 30-item instrument on three scales providing a QoV score in terms of symptom frequency, severity, and bothersome. It is suitable for measuring QoV in patients with all types of refractive correction, eye surgery, and eye disease that cause QoV problems [McAlinden, 2010]. The score ranges are 0 to 100 with smaller scales indicating better results.

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

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

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

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

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

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

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

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

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

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

IOL axis will be subjectively measured by the examiner during the slit lamp examination with dilated eyes. Only for the PODEYE toric implanted eyes.

Posterior capsule grading should be performed after pupil dilation at the follow up visits mentioned in the examination matrix. The status of the posterior capsule should be noted to be either "intact" or "not intact". If the capsule is intact, the presence of PCO and/or Elschnig's pearls will be documented as "present" or "absent". If "present", the location and clinical significance of the finding will be documented. Posterior capsular opacification (PCO) will be graded using the following scale:

0: None

• Minimal
• Mild
• Moderate
• Severe

A Halo and Glare simulator software (Eyeland Design Network GmbH, Germany) will be used to assess the subjective perception of photic phenomena. The patients will be asked to adjust the halo and glare level in a simulated image to the amount they perceive of such photic phenomena. This test is performed pre- and postoperatively. The preoperative outcomes serve as a baseline measurement.

This simulator utilizes a scale for intensity, size of the halo, and glare that ranges from zero (none) to 100 (extremely disturbing). It also allows for classifying the halos into three types, as follows: T1 (diffuse halo ring), T2 (starburst type), and T3 (distinct halo ring) [Kretz, 2015].

The SPE rates of the investigational product will be compared to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.2).

Rates of adverse events as determined by EN ISO 11979-7:2018 will be reported through the complete study follow-up. The proportion of all subjects with these events will be reported over time. Statistical comparisons to EN ISO 11979-7:2018 SPE (Safety and Performance Endpoints) rates (Annex E) will be based on all eyes implanted with the investigational device using a one-sided, exact test based on the binomial distribution.

Prior to the study start, a standard medication will be defined that all patients will receive and that is standard for cataract surgery. Only changes to the standard concomitant medication will be documented in the CRFs.