The SPECTRUM registry: 12 and 24 month results from a global real-world study of 2400 glaucoma eyes treated with micro invasive glaucoma surgery using the Hydrus® microstent

Session Details

Session Title: Glaucoma & Posterior Segment

Session Date/Time: Monday 24/09/2018 | 08:00-10:30

Paper Time: 08:54

Venue: Room A3, Podium 1

First Author: : G.Gazzard UK

Co Author(s): :                        

Abstract Details

Purpose:

The purpose of the SPECTRUM registry is to collect and evaluate real world safety and effectiveness outcomes for all forms of glaucoma treated with the Hydrus Microstent (Ivantis, Irvine CA) either in combination with cataract surgery or as a standalone surgery. The size of the registry will allow for assessment of the use of the Hydrus in multiple clinical and geographic. Spectrum investigators include both glaucoma and cataract surgeons from clinics world wide.

Setting:

The SPECTRUM registry has been conducted in 51 clinics located in 17 countries in Europe, North America, South America, the Middle East, and Asia/Pacific Rim. Over 60 surgeons are participating in the registry.

Methods:

SPECTRUM is an open label registry including open and closed angle forms of glaucoma. Participating surgeons are required to enter all Hydrus cases performed at their site in the data base through a secure web portal. Data includes baseline demographic and ocular status, IOP, medication count, visual field mean deviation, and history of prior glaucoma or ocular surgeries. A follow-up visit was conducted between 1 and 3 months and repeated annually. IOP, medication, and adverse event outcomes were collected. 2495 eyes were registered between 2013-2017. Follow-up is complete in 62% at 12 months and 32% at 24 months.

Results:

The predominant diagnosis was primary open angle glaucoma (71%). Average MD was -7.2 +/-9.1 dB. 73% of procedures were performed with cataract surgery; 27% were performed standalone (SA). 9.2% of SA eyes had prior filtration surgery. 62% of SA were in pseudophakes. In the combination group, IOP was reduced at 12 and 24 months by 19.6% and 20.6% (p<0.05) and medications were reduced 59.2% and 51.2% (p<0.05) respectively. In the SA group, IOP was reduced at 12 and 24 months by 22.2% and 23.8% (p<0.05) and medications were reduced 40.9% and 34.3% (p<-0.05) respectively.

Conclusions:

This large scale online multicenter global registry shows that the Hydrus MIGS device can be broadly used in different classes of glaucoma, either in combination with cataract surgery or as a standalone procedure. IOP and medication use is significantly reduced at 12 and 24 months in both types of procedure. Follow-up is ongoing.

Financial Disclosure:

-