Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses (PHY1803)

July 8, 2021 updated by: Beaver-Visitec International, Inc.

Comparison of Clinical Outcomes After Implantation of MICROPURE (PhysIOL) and PodEye (PhysIOL) Monofocal Intraocular Lenses Into the Two Eyes of the Same Patient

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses.

Study Overview

Status

Completed

Detailed Description

This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in the contralateral eye of the same patient.

The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. and PODEYE

The devices under investigation (Micropure 1.2.3. and PODEYE) are a monofocal glistening-free hydrophobic acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The optical properties of the lenses are very comparable. The main difference is the mechanical design of the haptics, that is not expected to have an influence on the clinical outcomes.

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

In total 76 patients will be recruited for this clinical study and receive the implantation of Micropure 1.2.3. and POPDEYE intraocular lenses.

Subjects participating in the trial will attend study visits over a period of 12 months.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zlin, Czechia, 76001
        • Gemini Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cataractous eyes with no comorbidity
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Clear intraocular media other than cataract;
  • Signed informed consent

Exclusion Criteria:

  • Age of patient < 45 years;
  • Irregular astigmatism;
  • Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°;
  • Difficulty for cooperation (distance from their home, general health condition);
  • Previous intraocular or corneal surgery;
  • Traumatic cataract;
  • Any ocular comorbidity;
  • Instability of keratometry or biometry measurements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational Device Micropure 1.2.3.
Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." in one of the eyes of the study subject
Implantation of intraocular lens (IOL). Name: "MicroPure 1.2.3." It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per patient will be implanted
Active Comparator: Comparator PODEYE
Implantation of monofocal intraocular lens (IOL) "PODEYE" in the contralateral eye of the study subject
Implantation of intraocular lens (IOL). Name: "PODEYE" It is a monofocal intraocular lens consisting of hydrophobic acrylic material. The IOL will be implanted in the contralateral eye of the same patient already implanted with Micropure 1.2.3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
monocular Corrected Distance Visual Acuity (CDVA)
Time Frame: 6 months postoperative
Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to eyes implanted with the comparator PODEYE at the 6 months follow up visit.
6 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manifested refraction
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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.
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under photopic light conditions
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
Time Frame: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions
preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under photopic light conditions
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
Time Frame: preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is performed under mesopic light conditions
preoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Monocular Contrast Sensitivity under photopic light conditions
Time Frame: 6 months postoperative
Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
6 months postoperative
Monocular Contrast Sensitivity under mesopic light conditions
Time Frame: 6 months postoperative
Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
6 months postoperative
Slitlamp examination - Corneal status
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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.

preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Fundus
Time Frame: preoperative, 12 months 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.

preoperative, 12 months postoperative
Slitlamp examination - Signs of inflammation
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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.

preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Pupillary block
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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.

preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Retinal detachment
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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.

preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - Status of anterior and posterior capsule
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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.

preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - IOL decentration
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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.

preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination IOL tilt
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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.

preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - IOL discoloration
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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.

preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Slitlamp examination - IOL opacity
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months 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.

preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure (IOP) measurement
Time Frame: preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
The IOP will be measured with non-contact tonometer as part of the routine follow up examinations
preoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative
Questionnaire on IOL implantation
Time Frame: peroperative
A questionnaire will be handed out to the surgeon right after the surgery to document the ease of use and possible issues during IOL implantation. These data will be used to compare the outcomes to different surgery techniques or injectors. The questionnaire is not validated and the outcomes serve only for the sponsor to receive feedback if one or the other IOL is easier to implant.
peroperative
Keratometry
Time Frame: preoperative
Keratometric measurements are performed to calculate the required IOL power
preoperative
Biometry
Time Frame: preoperative
Biometry measurements are performed to calculate the required IOL power
preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pavel Stodulka, MD, PhD, Gemini Eye Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2019

Primary Completion (Actual)

June 17, 2021

Study Completion (Actual)

June 17, 2021

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 4, 2019

First Posted (Actual)

January 8, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHY1803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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