PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Europe (PHY2104)

Browse trials for

• Cataract 1,701
• Astigmatism 413

Keywords

• Intraocular Lens
• Monofocal
• Toric Lens

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 28 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Lead sponsor

Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.

Study arms

• Experimental
  PODEYE TORIC IOL Implantation experimental

  Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC

  Device: IOL implantation experimental

Interventions

• DeviceIOL implantation experimental

  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).

Primary outcomes

1. 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.

   Time frame: 6 months postoperative

Secondary outcomes

1. 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.

   Time frame: Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

2. 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.

   Time frame: Pre-Op, 1 month postoperative, 6 months postoperative, 12 months postoperative

Other outcomes

1. Intraocular pressure (IOP) measurement

   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.

   Time frame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

2. Keratometry

   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.

   Time frame: Pre-Op, 1 month postoperative, 6 months postoperative

3. Biometry

   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.

   Time frame: Pre-Op

4. IOL power

   The power of the implanted IOL must be recorded.

   Time frame: during surgery

5. Target refraction

   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.

   Time frame: during surgery

6. Fundus OCT

   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.

   Time frame: Pre-Op, 6 months postoperative

7. Pupil Size (photopic)

   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.

   Time frame: Pre-Op, 6 months postoperative

8. Pupil Size (mesopic)

   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.

   Time frame: Pre-Op, 6 months postoperative

9. Manifest refraction

   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.

   Time frame: Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

10. Uncorrected Distance Visual Acuity (UDVA) - monocular

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

    Time frame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

11. Uncorrected Distance Visual Acuity (UDVA) - monocular mesopic

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

    Time frame: 6 months postoperative, 12 months postoperative

12. Uncorrected Distance Visual Acuity (UDVA) - binocular

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

    Time frame: 6 months postoperative, 12 months postoperative

13. Uncorrected Distance Visual Acuity (UDVA) - binocular mesopic

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

    Time frame: 6 months postoperative, 12 months postoperative

14. Corrected Distance Visual Acuity (CDVA) - monocular

    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.

    Time frame: Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

15. Corrected Distance Visual Acuity (CDVA) - monocular mesopic

    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.

    Time frame: 6 months postoperative, 12 months postoperative

16. Corrected Distance Visual Acuity (CDVA) - binocular

    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.

    Time frame: 6 months postoperative, 12 months postoperative

17. Corrected Distance Visual Acuity (CDVA) - binocular mesopic

    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.

    Time frame: 6 months postoperative, 12 months postoperative

18. Binocular Contrast Sensitivity under photopic light conditions

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

    Time frame: 6 months postoperative, 12 months postoperative

19. Binocular Contrast Sensitivity under mesopic light conditions

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

    Time frame: 6 months postoperative, 12 months postoperative

20. Binocular Contrast Sensitivity under photopic light conditions and using a glare source

    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.

    Time frame: 6 months postoperative, 12 months postoperative

21. Binocular Contrast Sensitivity under mesopic light conditions and using a glare source

    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.

    Time frame: 6 months postoperative, 12 months postoperative

22. Patient reported outcomes, Quality of Vision Questionnaire

    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.

    Time frame: Pre-Op, 6 months postoperative

23. Slitlamp examination - 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: • Corneal Status

    Time frame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

24. Fundus examination with dilated pupil

    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

    Time frame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

25. Slitlamp examination - Signs of inflammation

    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

    Time frame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

26. Slitlamp examination - 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: • Pupillary block

    Time frame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

27. Slitlamp examination - 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: • Retinal detachment

    Time frame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

28. Slitlamp examination - 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: • Status of anterior and posterior capsule

    Time frame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

29. Slitlamp examination - 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 decentration

    Time frame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

30. Slitlamp examination - 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 tilt

    Time frame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

31. Slitlamp examination - 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 discoloration

    Time frame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

32. Slitlamp examination - IOL opacity

    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

    Time frame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

33. Manual assessment of IOL axis position

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

    Time frame: within 10 minutes after surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

34. PCO grading

    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 1. Minimal 2. Mild 3. Moderate 4. Severe

    Time frame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

35. Halo and Glare Scores (binocular)

    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) \[Kretz, 2015\].

    Time frame: Pre-Op, 6 months postoperative

36. Safety outcomes

    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.

    Time frame: Pre-Op, during surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

37. Medication Revision

    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.

    Time frame: Pre-Op, during surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

Publications

• 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. PubMed 20505205 ↗
• Kretz FT, Breyer D, Klabe K, Hagen P, Kaymak H, Koss MJ, Gerl M, Mueller M, Gerl RH, Auffarth GU. Clinical Outcomes After Implantation of a Trifocal Toric Intraocular Lens. J Refract Surg. 2015 Aug;31(8):504-10. doi: 10.3928/1081597X-20150622-01. PubMed 26274516 ↗

Individual participant data

Plan to share: No