Skip to main content
OpenTrials
Completed

NCT Number: NCT05875922

Comparison of ISOPURE and EYHANCE (Switzerland)

This is a prospective randomised open-label study with the aim to compare the visual performance of the premium monofocal Isopure IOL versus the extended depth of focus Eyhance® IOL after phaco-emulsification cataract surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases Lens Opacities

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye center Vista Alpina

Visp, 3930, Switzerland

About this study

This is a single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of premium monofocal intraocular lenses (PhysIOL ISOPURE 1.2.3.) or EDOF lenses (TECNIS Eyhance). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation is being carried out. The investigational device 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 device under investigation (ISOPURE 1.2.3.) is a hydrophobic, glistening-free, acrylic premium monofocal intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens (TECNIS Eyhance) is a non-diffractive Extended Vision Posterior Chamber IOL.

The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of 6 study visits (1 preoperative, 1 operative and 4 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.

Primary and secondary endpoint data will be collected at the 120-180 days follow up visit.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cataractous eyes with no comorbidity;
  • Calculated IOL power is within the range of the study IOLs;
  • Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
  • Regular total corneal astigmatism ≤1.0 D (measured by topography method)
  • Clear intraocular media other than cataract;
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
  • Expected postoperative Best Corrected Distance Visual Acuity (CDVA) ≤ 0.2 logMAR;
  • Signed informed consent.

Exclusion criteria

  • Age of patient < 50 years;
  • Regular total corneal astigmatism >1.0 dioptres (measured by topography method)
  • Irregular astigmatism;
  • 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 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 or macula pucker; previous laser treatment for peripheral retinal tears is allowed;
  • Previous intraocular or corneal surgery or intravitreal injection;
  • Traumatic cataract;
  • History or presence of macular edema;
  • Glaucoma with visual field defects; or RNFL defects on OCT; ocular hypertension is allowed;
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
  • Amblyopia with monocular preoperative CDVA of >0.1 logMAR;
  • Cornea guttata;
  • Keratoconus;
  • Chronic uveitis;
  • Expected complicated surgery;
  • Significant dry eye;
  • Contra-indications as listed in the current Instructions for use (IFU);
  • Contra-indication or unwillingness to perform immediate sequential bilateral cataract surgery;
  • Concurrent or previous (within 60 days) 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 or defect;
  • 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.

Treatment and study plan

IOL implantation experimental (Isopure 1.2.3.)

Device

Implantation of premium monofocal IOL ISOPURE 1.2.3.

IOL implantation active comparator (TECNIS Eyhance)

Device

Implantation of EDOF IOL TECNIS Eyhance

Primary outcomes

  1. monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.

    Time frame: 6 months (120-180 days) postoperative

    Non inferiority of ISOPURE 1.2.3. outcomes compared to the TECNIS Eyehance outcomes in terms of monocular Best Corrected Distance Visual Acuity (CDVA) by means of statistical significance.

    A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.

Secondary outcomes

  1. Safety (Rates of Adverse Events)

    Time frame: 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

    The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.2)

Other outcomes

  1. Intraocular pressure (IOP) measurement

    Time frame: Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (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. Anterior Chamber Depth

    Time frame: Preoperative

    Anterior Chamber Depth measurement is performed using the IOLMaster device. This measurement is required to calculate the required IOL power. The measurement unit is mm. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

  3. Axial Lenght

    Time frame: Preoperative

    Axial Length measurement is performed using the IOLMaster device. This measurement is required to calculate the required IOL power. The measurement unit is mm. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

  4. Lens Thickness

    Time frame: Preoperative

    Lens Thickness measurement is performed using the IOLMaster device to asses the dimension of the natural lnes. This measurement is required to calculate the required IOL power. The measurement unit is mm. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

  5. Keratometry measurement - K values

    Time frame: Preoperative

    Keratometric measurements are performed to calculate the required IOL power. The measurement is performed using the IOLMaster device. This specific outcome measure is to measure the K value in the steep axis (K1) and flat axis (K2). The measurement unit is diopter (D). The examination is performed and documented according to the guidelines in ISO 11979-7:2018.

  6. IOL power

    Time frame: Operative (day of surgery)

    The IOL spherical power of the implanted IOL must be recorded.

  7. Target refraction

    Time frame: Operative (day of surgery)

    The target refraction given by the IOL calculator must be recorded. 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.

  8. Fundus OCT

    Time frame: Preoperative, 1 month (30-60 days) postoperative

    An OCT (optical coherence tomography) image will be taken at the preoperative visit and 1 months postoperative 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.

  9. Pupil Size under mesopic light conditions

    Time frame: preoperative

    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.

  10. Manifested refraction

    Time frame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (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 11979-7:2018. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)

  11. Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions

    Time frame: Preoperative, 1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

    monocular and binocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.

  12. Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions

    Time frame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

    Binocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.

  13. Binocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions

    Time frame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

    Binocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.

  14. Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions

    Time frame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

    Monocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.

  15. Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions

    Time frame: 6 months (120-180 days) postoperative

    Binocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.

  16. Monocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions

    Time frame: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

    Monocular DCIVA@66cm is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.

  17. Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under mesopic light condition

    Time frame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

    Binocular UIVA@66cm is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.

  18. Monocular Distance Corrected Near Visual Acuity at 40cm (DCNVA) under photopic light conditions

    Time frame: 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

    Monocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.

  19. Binocular Uncorrected Near Visual Acuity at 40cm (UNVA) under photopic light conditions

    Time frame: 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative

    Monocular UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.

  20. Binocular Defocus Curve

    Time frame: 1 month (30-60 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 -2.5 D to +1.5 D in 0.5 D steps. This examination is performed binocularly.

  21. Binocular Contrast Sensitivity under photopic light conditions

    Time frame: 6 months (120-180 days) postoperative

    Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (Vector Vision). This examination is performed binocularly.

  22. Binocular Contrast Sensitivity under mesopic light conditions

    Time frame: 6 months (120-180 days) postoperative

    Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (Vector Vision). This examination is performed binocularly.

  23. Slitlamp examination - Corneal status

    Time frame: Preoperative, 1 month (30-60 days) postoperative, 6 months (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

  24. Slitlamp examination - Signs of inflammation

    Time frame: Preoperative, 1 month (30-60 days) postoperative, 6 months (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

  25. Slitlamp examination - Iris status

    Time frame: Preoperative, 1 month (30-60 days) postoperative, 6 months (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:

    • Iris status

  26. Fundus examination with dilated pupil

    Time frame: Preoperative, 1 month (30-60 days) postoperative, 6 months (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

  27. Slitlamp examination - Optic nerve cupping

    Time frame: Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 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:

    • Optic nerve cupping

  28. Slitlamp examination - Posterior Capsular Opacification (PCO) or Posterior Capsular Fibrosis

    Time frame: 1 month (30-60 days) postoperative, 6 months (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:

    • Posterior Capsular Opacification (PCO) or Posterior Capsular Fibrosis

  29. Slitlamp examination - IOL discoloration

    Time frame: 6 months (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.

  30. Slitlamp examination - abnormal IOL positioning

    Time frame: 1 month (30-60 days) postoperative, 6 months (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:

    • abnormal IOL positioning

  31. Patient reported outcomes - Quality of Vision questionnaire

    Time frame: 6 months (120-180 days) postoperative

    To assess the subjective perception of disturbances by photic phenomena. Subjects answer one question per category on their individual perception of glare, halo and starbursts, respectively. Answers are graded in 5 steps between always and never.

    Descriptive analysis will be performed on the occurence of photic phenomena per category. This questionnaire does not consist of a scaling.

  32. Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]

    Time frame: 6 months (120-180 days) postoperative

    The Patient-Reported Spectacle Independence Questionnaire (PRSIQ) is a patient-reported measure assessing spectacle independence following cataract surgery. The analyses conducted provide evidence for the use of the PRSIQ total score as a measure of spectacle independence [Morlock et al, 2017].

    In the first category, subjects are asked if they need glasses for distance vision, intermediate vision and near vision with 'yes' and 'no' being the only possible answers.

    In the second category, patients are asked to scale their frequency of using spectacles over the last 7 days for three different distances with 5 ratings ranging from '1: All of the time' to '5: None of the time'. A higher rating means higher rate of spectacle independence.

    In addition, patients are asked to scale if they are able to function without spectacle aid for three different distances with 5 ratings ranging from '1: All of the time' to '5: None of the time'. A higher rating means higher rate of spectacle freedom.

Sponsors and collaborators

Lead sponsor

Beaver-Visitec International, Inc.

Industry

Collaborators

  • targomedGmbH

Registry information

Official study title

Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a ISOPURE and EYHANCE Intraocular Lenses (IOL)

Acronym: PHY2301

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 25, 2023
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.