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Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04054427
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Physiol

Brief Summary:
Controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study to investigate visual performance after implantation of a trifocal IOL (PhysIOL Pod L GF) in patients that underwent refractive surgery.

Condition or disease Intervention/treatment Phase
Cataract Lens Opacities Presbyopia Device: IOL implantation experimental Not Applicable

Detailed Description:

This clinical investigation is a controlled, open label, prospective Post Market Clinical Follow-Up, single-center clinical study whereby patients undergoing routine cataract surgery that previously underwent refractive surgery prior to being screened will have bilateral implantation of trifocal intraocular lens FineVision POD L GF (PhysIOL, Liège, Belgium).

The study purpose is to collect clinical data on visual acuity, contrast sensitivity and patient reported outcomes obtained on patients with cataracts and/or suffering from presbyopia that underwent refractive surgery prior to the IOL implantation.

The device under investigation (FineVision POD L GF) is a trifocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 28 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD L GF intraocular lens.

Subjects participating in the trial will attend a total of 9 study visits (1 preoperative, 2 operative and 6 postoperative) over a period of 6 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Investigate Visual Performance and Patient Satisfaction After Implantation of a Trifocal Hydrophobic IOL in Patients That Underwent Refractive Surgery
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: IOL implantation experimental
hydrophobic, trifocal intraocular lens POD L GF
Device: IOL implantation experimental
Implantation of trifocal IOL POD L GF consisting of hydrophobic material




Primary Outcome Measures :
  1. Monocular Best Corrected Distance Visual Acuity (CDVA) [ Time Frame: 6 months (120-180 days) postoperative ]
    Statistically significant non-inferiority with POD L GF on monocular CDVA in comparison to literature data. A significance level of 0.05 will be considered statistically significant.


Secondary Outcome Measures :
  1. Manifest refraction (sphere and cylinder) [ Time Frame: Pre-OP, 1-2 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2014

  2. Pupil Size Photopic [ Time Frame: 120-180 days postoperative ]
    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).

  3. Pupil Size Mesopic [ Time Frame: 120-180 days postoperative ]
    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).

  4. Uncorrected Distance Visual Acuity (UDVA) - monocular [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]
    UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions

  5. Uncorrected Distance Visual Acuity (UDVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.

  6. Corrected Distance Visual Acuity (CDVA) - monocular [ Time Frame: Pre-OP, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]
    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.

  7. Corrected Distance Visual Acuity (CDVA) - binocular [ Time Frame: 120-180 days postoperative ]
    Monocular and Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic and mesopic light conditions at 80cm distance

  8. Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.

  9. Uncorrected Intermediate Visual Acuity at 80cm (UIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 80cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.

  10. Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.

  11. Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.

  12. Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) - monocular mesopic [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions

  13. Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.

  14. Uncorrected Intermediate Visual Acuity at 66cm (UIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UIVA is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.

  15. Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions.

  16. Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - binocular [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions.

  17. Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA) - monocular mesopic. [ Time Frame: 120-180 days postoperative ]
    DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions

  18. Uncorrected Near Visual Acuity at 40cm (UNVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions

  19. Uncorrected Near Visual Acuity at 40cm (UNVA) - binocular [ Time Frame: 120-180 days postoperative ]
    UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions

  20. Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular [ Time Frame: 7-14 days post operative, 30-60 days postoperative, 120-180 days postoperative ]
    DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under photopic conditions

  21. Distance Corrected Near Visual Acuity at 40cm (DCNVA) - binocular [ Time Frame: 120-180 days postoperative ]
    DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done binocularly under photopic conditions

  22. Distance Corrected Near Visual Acuity at 40cm (DCNVA) - monocular mesopic [ Time Frame: 120-180 days postoperative ]
    DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic conditions

  23. Defocus Curve [ Time Frame: 120-180 days postoperative ]
    To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -4.0 D to +2.0 D. This examination is performed binocularly

  24. Binocular Contrast Sensitivity under photopic light conditions [ Time Frame: 120-180 days postoperative ]
    Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.

  25. Binocular Contrast Sensitivity under mesopic light conditions [ Time Frame: 120-180 days postoperative ]
    Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device Clinical Trial Suite (M&S Technologies). This examination is performed binocularly.

  26. Binocular Contrast Sensitivity under mesopic light conditions and using a glare source [ Time Frame: 120-180 days postoperative ]
    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.

  27. Patient reported outcomes: Quality of Vision Questionnaire (QoV) quality of vision [ Time Frame: 120-180 days postoperative ]
    Quality of vision based on response to each question in the Quality of Vision (QoV) questionnaire. Answer is a choice of 4 options, the first being the least and the fourth being the most based on question type, i.e. "never" to "very often" or "not at all" to "severe".

  28. Patient reported outcomes: Near Activity Visual Questionnaire (NAVQ) quality of vision [ Time Frame: 120-180 days postoperative ]
    Quality of vision based on response (choice of 0-3 with 0 meaning no difficulty and 3 meaning extreme difficulty) to each question in the Near Activity Visual Questionnaire (NAVQ)

  29. Slit lamp examination - Corneal Status [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]

    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


  30. Fundus examination with dilated pupil [ Time Frame: Pre Op, 120-180 days postoperative ]

    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


  31. Slit lamp examination - Signs of inflammation [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]

    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


  32. Slit lamp examination - Pupillary block [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]

    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


  33. Slit lamp examination - Retinal detachment [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]

    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


  34. Slit lamp examination - Status of anterior and posterior capsule [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]

    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


  35. Slit lamp examination - IOL decentration [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]

    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


  36. Slit lamp examination - IOL tilt [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]

    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


  37. Slit lamp examination - IOL discoloration [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]

    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


  38. Slit lamp examination - IOL opacity [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]

    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



Other Outcome Measures:
  1. Intraocular pressure (IOP) measurement [ Time Frame: Pre-OP, 1-2 days post operative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative ]
    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

  2. Keratometry [ Time Frame: Pre-OP ]
    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.

  3. Biometry [ Time Frame: Pre-OP ]
    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.

  4. IOL power and target refraction [ Time Frame: Operative (day of Surgery) ]
    The parameter of the implanted IOL must be recorded as well as the target refraction given by the IOL calculator. 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.

  5. Fundus OCT [ Time Frame: Pre-OP ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cataracteous eyes with no comorbidity;
  • Post LASIK, post PRK/surface ablation or post RK (radial keratotomy) patients with day of refractive surgery minimum 24 months before IOL implantation;
  • Calculated IOL power is within the range of the study IOLs;
  • Fulfill CHRU (Centre Hospitalier Regional Universitaire) internal criteria for multifocal lenses implantation on post-refractive surgery patients.
  • Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes or suffer from presbyopia;
  • Clear intraocular media other than cataract;
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
  • Signed informed consent

Exclusion Criteria:

  • Age of patient < 45 years;
  • Irregular topographic examination where limitation in clinical outcomes are expected.
  • Patients that underwent presbyopia correcting refractive surgery (e.g. PresbyLASIK, SUPRACOR, INTRACOR)
  • Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
  • Subjects with AMD suspicious eyes as determined by OCT examination;
  • Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
  • Traumatic cataract;
  • History or presence of macular edema;
  • Concurrent or previous (within 30 days) participation in another drug or device investigation;
  • Instability of keratometry or biometry measurements;
  • Ocular hypertension or glaucoma;
  • Significant dry eye;
  • Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgement (reason to be documented on the CRF).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054427


Contacts
Layout table for location contacts
Contact: Jochen Kandulla, PhD +49 157 862 75281 j.kandulla@physiol.be
Contact: Rebecca McQuaid, PhD +353871212615 r.mcquaid@physiol.be

Sponsors and Collaborators
Physiol
Investigators
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Principal Investigator: Béatrice Cochener, Prof Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis

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Responsible Party: Physiol
ClinicalTrials.gov Identifier: NCT04054427     History of Changes
Other Study ID Numbers: PHY1902
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Physiol:
Intraocular Lens
Trifocal
hydrophobic
Post refractive surgery
Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors