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iStent Significantly Reduces Unmedicated IOP in Glaucoma

iStent Significantly Reduces Unmedicated IOP in Glaucoma

Glaukos’ iStent inject trabecular micro-bypass system achieved a statistically significant reduction in unmedicated diurnal intraocular pressure (IOP) in patients undergoing cataract surgery, according to results from a two-year U.S. Investigational Device Exemption (IDE) pivotal trial data.

Results of the iStent inject prospective, randomised, multicenter clinical trial, which included 41 investigational sites and 505 open-angle glaucoma (OAG) subjects, were presented at the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting by Dr. Thomas W. Samuelson, an ophthalmic surgeon at Minnesota Eye Consultants. In the study, 387 subjects were randomised to iStent inject in combination with cataract surgery and 118 subjects were randomised to cataract surgery only. Subjects were followed through 24 months with annual medication washouts.

The iStent inject met the study’s primary and secondary effectiveness endpoints as follows:

  • At 24 months, 75.3 per cent of the iStent inject cohort achieved a 20 per cent or greater reduction in unmedicated IOP, compared to 61.9 per cent for the cataract-only cohort.
  • At 24 months, the mean unmedicated IOP reduction was 6.9 mmHg for the iStent inject cohort, compared to 5.4 mmHg for the cataract-only cohort.
  • Through 24 months, the overall rate of adverse events for the iStent inject, in combination with cataract surgery, was similar to cataract surgery only.

Additional Findings

While not part of the effectiveness claims being pursued by the company, additional key findings include:

At 24 months, observed data show that the iStent inject cohort achieved a 31 per cent mean reduction in unmedicated (post-washout) IOP to 17.1 mmHg from an unmedicated (post-washout) mean baseline IOP of 24.8 mmHg.

At 24 months, observed data show that 62.6 per cent of the iStent inject cohort achieved unmedicated mean IOP at or below 18 mmHg, compared to 49.2 per cent for the cataract-only cohort.

At 23 months, observed data show that the iStent inject cohort achieved a 75 per cent reduction in the mean number of medications, compared to 47 per cent for the cataract-only cohort.

The iStent inject is designed to improve aqueous humor outflow into Schlemm’s canal and reduce IOP in mild-to-moderate Open Angle Glaucoma (OAG) patients undergoing cataract surgery. It includes two heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point.

The iStent inject relies on the same fluidic method of action as Glaukos’ first-generation iStent trabecular micro-bypass stent, which was approved by the U.S. Food and Drug Administration (FDA) in 2012 and has been shown to lower IOP in adult cataract patients with mild-to-moderate OAG. Each iStent inject stent is approximately 0.23 mm x 0.36 mm, or about one-third the size of iStent, which the company believes is the smallest medical device ever approved by the FDA.

The iStent inject is commercially available in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore and South Africa. The iStent inject is not approved for use in the U.S. Glaukos submitted a pre-market approval application for the iStent inject to the FDA in December 2017

Glaukos is also currently pursuing FDA approval for four additional MIGS surgical and sustained pharmaceutical therapy pipeline products, all of which are investigational in the U.S.:

  • iStent SA trabecular micro-bypass system, which is a standalone, two-stent procedure that is similar to the iStent inject and designed to reduce IOP in pseudophakic, mild-to-moderate OAG eyes.
  • iStent infinite trabecular micro-bypass system, which is a standalone, three-stent procedure, designed to reduce IOP in refractory OAG patients.
  • iStent supra suprachoroidal micro-bypass stent, which is designed to reduce IOP in mild-to-moderate OAG subjects undergoing cataract surgery by accessing the eye’s suprachoroidal space. This device is approved in the European Union.
  • iDose travoprost, which is an implant containing a special formulation of travoprost, a prostaglandin analog used to reduce IOP. Implanted during a micro-invasive procedure, the iDose travoprost is designed to continuously elute therapeutic levels of the medication from within the eye for extended periods of time.

Published by mivision | 9 May 2018

most experienced lasik surgeons

FOCUS on the 3 C’s – Cornea, Chalazion & Cross Linking

FOCUS on the “Three C’s” : A presentation on Cornea, Chalazion & Cross Linking

Presented by: Dr Con Petsoglou – Ophthalmic Surgeon – FOCUS Eye Centre

Presented at: “Ophthalmology Update” October CPD event – FOCUS Eye Centre

We Love Lasers – CPD evening

On Tuesday the 25th of August, Focus Laser Eye Centre hosted a 6pt CPD evening for optometrists with the theme We Love Lasers. With 5 talks presented by our leading Laser Surgeons, the evening was very rewarding.

Nigel Whittle of MTH Clinic says:

I’d like to thank you for a great educational experience tonight.

The venue, the practice, was transformed into an environment where I think we all felt comfortable and relaxed. That being, it provided a platform for easy understanding and information absorption from expert and dedicated surgeon specialists.

The topics covered were done so in a professional yet down-to-earth manner. I love lasers more now too!!

The catering was exceptional….. I suspect you had a hand in that yourself, so thanks there also.

Please pass on my sincere thanks to Dr’s Margaret and Richard and their associates.

 

Lessons Learned With Electronic Health Records ( EHR )

By Dr Richard Smith, MBBS, BSc, DO, FRCS, FRACS, FRANZCO
Published in Cataract & Refractive Surgery Today Europe’s (CRST) – June edition.

Transitioning to electronic health records involves a learning curve but can lead to increased efficiency and cost containment.

AT A GLANCE

  • The elimination of paper charts can yield savings in time, space, and money and increase access to patient data.
  • An Electronic Health Records ( EHR ) system can help provide a practice with a more modern style of patient consulting and facilitate patient education.
  • For some practices, adopting Electronic Health Records ( EHRs ) is one step toward a larger goal of transitioning to a paperless environment in which other processes, such as accounting and staff management, can be digitised as well.
Best laser eye technology

FOCUS on use of excimer lasers ( TG PRK )

Dr Gregory Moloney, visiting Corneal Specialist for FOCUS Eye Centre’s collection of works on recent clinical results of topography-based Customized Ablations

Article 1 – “Clinical Results of Topography-based Customized Ablations in Highly Aberrated Eyes and Keratoconus / Ectasia With Cross-linking” Download

Presentation 2 – “Topography-Guided Photorefractive Keratectomy TG PRK” – Presented at ESCRS 2012″ Download

Article 3 – “Lin Holland Tan Current opinion” Download

Refractive surgery for the over 50’s

Refractive surgery for the over 50’s : A presentation on Refractive Surgery for the over 50s, their refractive options which have changed with age – the risks as well as the benefits

Presented by: Dr Margaret Kearns – Ophthalmic Surgeon – FOCUS Eye Centre

Presented at: “Ophthalmology Update” October CPD event – FOCUS Eye Centre

Headaches in Ophthalmology

Headaches in Ophthalmology : A presentation on Headaches – How to diagnose and treat ophthalmic causes of headache.

Presented by: Dr Paula Berdoukas – Ophthalmic Surgeon – FOCUS Eye Centre

Presented at: “Ophthalmology Update” October CPD event – FOCUS Eye Centre

Best laser eye technology

Cataract Surgery Pros and Cons

CATARACT SURGERY Pros and Cons: A presentation on the the Pros and Cons of Phaco vs Femto and Monofocal vs Multifocal IOLs.

Presented by: Dr Richard Smith – Ophthalmic Surgeon – FOCUS Eye Centre

Presented at: “Ophthalmology Update” October CPD event – FOCUS Eye Centre

fasting before cataract eye surgery

Why is fasting before cataract eye surgery important ?

Sometimes, even though patients know they will have intravenous sedation, they still do not understand why fasting before cataract eye surgery is necessary. On occasion a patient arrives for cataract surgery having eaten breakfast and unfortunately in these cases surgery has to be postponed, which can be very inconvenient for patients and doctors alike.

So why do you need to fast?

Fasting before cataract eye surgery reduces the risk of stomach contents/acid going the wrong way down into your lungs while you are asleep. Stomach acid can cause lung damage.

What is the correct way for fasting before cataract surgery?

  • NO solid food is to be eaten for at least 6 hours prior to your admission time.
  • NO fluids (except water, black tea or black coffee) are to be taken for at least 2 hours before your admission time.

Your regular medications may be taken at their usual time with a sip of water.

This is prepared by Anaesthetist
Dr Joanne Silverton 

eye conditions, cataract simulation

Cataracts – Causes, Symptoms, Diagnosis and Treatments

What are cataracts ?

Cataracts are a clouding of the crystalline lens of the eye. This in turn affects vision. Cataracts form for many reasons but the most common is age.  It is normal for people over the age of 65 to have some mild form of cataracts. Causes of Cataract development include age, steroid use, trauma, radiation, or as a result of other eye conditions such as glaucoma.  Cataracts can occur in one or both eyes, sometimes years apart, but it cannot spread from one eye to another.

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