Clinical trial NCT04329754: Safety and Efficacy of a Novel Hydrophobic Acrylic IOL - iPure: a Randomised Study
Official title: Safety and Efficacy of a Novel Hydrophobic Acrylic IOL - iPure: a Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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°.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rotational Stability
timeFrame: 2 years
Secondary outcomes:
measure: Glistening
timeFrame: 2 years
measure: visual acuity
timeFrame: 2 years
measure: PCO
timeFrame: 2 years
measure: Decentration in mm
timeFrame: 2 years
measure: Tilt in degrees
timeFrame: 2 years
measure: Capsulorhexis area
timeFrame: 2 years
measure: Anterior chamber depth
timeFrame: 2 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Study officials:
affiliation: VIROS, Hanusch Hospital Vienna
name: Oliver Findl, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: