Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation (PHY1801)

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.

Study Overview

• Status: Completed
• Conditions: Cataract; Lens Opacities
• Intervention / Treatment: Device: Micropure 1.2.3.

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 bilateral implantation of monofocal intraocular lenses Micropure 1.2.3. (PhysIOL, Liège, Belgium)

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

The device under investigation (Micropure 1.2.3.) is a monofocal 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 50 patients will be recruited for this clinical study and receive a bilateral implantation of Micropure 1.2.3. intraocular lens.

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 2 Years.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Ophtalmology department - CHU liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cataractous eyes with no comorbidity
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Signed informed consent

Exclusion Criteria:

• Irregular astigmatism
• Age of patient < 45 years
• 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)
• Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
• Any ocular comorbidity
• History of ocular trauma or prior ocular surgery including refractive procedures
• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
• Complicated surgery
• Patients who do not give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm: Investigational Device; Implantation of monofocal intraocular lens (IOL) "Micropure 1.2.3." consisting of hydrophobic material	Device: Micropure 1.2.3.; Implantation of intraocular lens (IOL). Name: "MicroPure 1.2.3." It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per eye will be implanted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monocular Corrected Distance Visual Acuity (CDVA)	Statistically non-inferior visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions compared to literature data on a monofocal hydrophilic IOL (Bausch & Lomb - Akreos MI60) at the 3 months follow up visit.	3 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manifested 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 11979-7:2014.	1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Uncorrected Distance Visual Acuity (UDVA)	UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.	1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)	UIVA is measured with ETDRS charts placed in 70cm distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.	1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)	DCIVA is measured with ETDRS charts placed in 70cm distance and using best distance corrected refraction according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.	1 month, 3 months, 12 months, 24 months postoperative
Binocular Corrected Distance Visual Acuity (CDVA)	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	1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular Contrast Sensitivity under photopic and mesopic light conditions	Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)	1 month, 3 months, 12 months, 24 months postoperative
Monocular and binocular assessment of defocus curve under photopic light conditions	To assess the visual acuity for different distances, defocus curves under photopic light conditions will be measured. This test is performed with best distance corrected refraction and spherical additions ranging from -2.0 D to +1.5 D	1 month, 3 months, 12 months, 24 months postoperative
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.	12 months, 24 months postoperative
Slitlamp examination - Fundus	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Fundus.	12 months, 24 months postoperative
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.	12 months, 24 months postoperative
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.	12 months, 24 months postoperative
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.	12 months, 24 months postoperative
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.	12 months, 24 months postoperative
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.	12 months, 24 months postoperative
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.	12 months, 24 months postoperative
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.	12 months, 24 months postoperative
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.	12 months, 24 months postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire on IOL implantation	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	Keratometric measurements are performed to calculate the required IOL power	preoperative
Biometry	Biometry measurements are performed to calculate the required IOL power	preoperative
Intraocular pressure (IOP) measurement	The IOP will be measured with non-contact tonometer as part of the routine follow up examinations	Pre-operative, 1 month, 3 months, 12 months, 24 months postoperative

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.
• Investigators: Principal Investigator: Francoise Van Cauwenberge, MD, Ophtalmology department - CHU liège

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2018
• Primary Completion (ACTUAL): July 27, 2021
• Study Completion (ACTUAL): July 27, 2021

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (ACTUAL): February 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Intraocular lens; Monofocal; Hydrophobic
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: PHY1801

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