NCT04329754

Brief Summary

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°.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
5.2 years until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

2.8 years

First QC Date

January 25, 2013

Last Update Submit

October 12, 2022

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Rotational Stability

    measured using the Purkinje meter (Murcia University) and retroillumination images (degrees of rotation)

    2 years

Secondary Outcomes (7)

  • Glistening

    2 years

  • visual acuity

    2 years

  • PCO

    2 years

  • Decentration in mm

    2 years

  • Tilt in degrees

    2 years

  • +2 more secondary outcomes

Study Arms (2)

iPure

OTHER

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

ZCB00

OTHER

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

Interventions

Cataract surgeryDEVICE

Cataract surgery with implantation of an intraocular lens (IOL)

ZCB00iPure

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Oliver Findl, MD, MBA

    VIROS, Hanusch Hospital Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Ophthalmology Department, principal investigator

Study Record Dates

First Submitted

January 25, 2013

First Posted

April 1, 2020

Study Start

April 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 17, 2022

Record last verified: 2022-10

Locations

AU(1)