Safety and Efficacy of a Novel Hydrophobic Acrylic IOL - iPure: a Randomised Study

In this study the rotational stability and performance - with respect to glistening and PCO formation - of a new hydrophobic acrylic IOL (IPure, PhysIOL, Belgium) will be compared to a gold standard IOL (AMO ZCB00) in a randomized controlled fashion. Fifty eyes of 50 patients will be included. 25 patients will receive the iPure and 25 patients will receive the standard IOL. Study hypothesis: The iPure IOL shows better rotational stability compared to the standard IOL. A clinically relevant difference for rotational stability is defined as 2°.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Cataract surgery

Detailed Description

Although there may be no direct benefit to the subjects under study, the investigation will assess the stability which determines the efficacy for future toric optics and the amount of glistening and PCO formation of the IPure and ZCB00 hydrophobic acrylic IOLs.

25 eyes of 25 patients will be recruited for each IOL, that is 50 eyes of 50 patients. The randomization will be done with a binomial law. The IOL have a priori the same IOL constants which eliminates the necessity to know which IOL is going to be implanted at the preoperative time. A clinically relevant difference for rotational stability will be 2°. The reasonable standard deviation of the position of an IOL in the eye is 2.4°. A total of 48 patients is necessary for a probability of 80% to measure a clinically relevant difference concerning the IOL stability.

In the week before surgery, the eye to be operated is examined at the slit-lamp and by indirect fundoscopy and measurement of intraocular pressure (IOP) will be performed routinely. Additionally, routine biometry is performed using the IOLMaster (Zeiss Meditec AG, Jena, Germany) for axial length measurement, K-readings and anterior chamber depth (ACD) measurements.

Randomisation will be performed using online randomisation and patients will be allocated 1:1 either to the study group (iPure group), or to the control group (ZCB00).

A self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed in a standardised fashion. The IOL is implanted via injector into the capsular bag. Following the implantation of the IOL, the viscoelastic substance is aspirated thoroughly from the anterior chamber, as well as retro-lentally, to assure complete removal of the OVD.

Any deviation from the standard protocol will be recorded peroperatively. Follow-ups will be performed 1-2 hours, 1 month, 12 months and 24 months after cataract surgery.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age-related cataract
• Age 21 and older
• Visual Acuity > 0.05
• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.

Exclusion Criteria:

• Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies
• Previous ocular surgery or trauma.
• Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: iPure; A new single-piece hydrophobic acrylic IOL (IPure IOL). The study IOL is a one-piece aspheric acrylic hydrophobic glistening-free lens, with a 4.9% water content, a 360 square posterior edge design, and a 5 haptic angulation, providing UV and blue-light filtration. Patient were allocated into two groups. The study group received the iPure lens while the control group received Tecnis ZCB00. Randomisation was done with a binomial law, using random.org. The surgeon was masked to IOL allocation until shortly before implantation. Examiners were masked to IOL allocation.	Device: Cataract surgery; Cataract surgery with implantation of an intraocular lens (IOL)
Other: ZCB00; A standard IOL (ZCB00).The control IOL, is a one-piece hydrophobic acrylic IOL with a biconvex aspheric optic and 360 continuous square posterior optic edge with a UV filter and an offset, stepped haptic design. Patient were allocated into two groups. The study group received the iPure lens while the control group received Tecnis ZCB00. Randomisation was done with a binomial law, using random.org. The surgeon was masked to IOL allocation until shortly before implantation. Examiners were masked to IOL allocation.	Device: Cataract surgery; Cataract surgery with implantation of an intraocular lens (IOL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotational Stability	measured using the Purkinje meter (Murcia University) and retroillumination images (degrees of rotation)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glistening	subjective measurement (0 to 4, 0 no glistening, 4 sever glistening)	2 years
visual acuity	assessed by ETDRS charts at 4m	2 years
PCO	scored with AQUA (0 to 10, 0 no PCO, 10 sever PCO) and the number of Nd:YAG capsulotomies	2 years
Decentration in mm	measured by Purkinjemeter	2 years
Tilt in degrees	measured by Purkinjemeter	2 years
Capsulorhexis area	assessed by retroillumination images	2 years
Anterior chamber depth	assessed by AC Master (in mm)	2 years

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery
• Investigators: Principal Investigator: Oliver Findl, MD, MBA, VIROS, Hanusch Hospital Vienna

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Viros_iPure