Biography:

Theodore Leng, MD, MS, is a practicing retina specialist, associate professor of ophthalmology and director of clinical and translational research at the Byers Eye Institute at Stanford, Stanford University Medical School. He has a research background in image analysis, machine learning algorithms, and clinical trial design and execution.

Biography: Michael Mbagwu, MD, is a practicing comprehensive ophthalmologist at the VA Palo Alto Health Care System and is a current Byers Ophthalmic Innovation Fellow at the Byers Eye Institute at Stanford, Stanford University Medical School. He has a research interest in medical informatics, application of real-world data and creation of AI algorithms for diagnosis/prognosis of ophthalmic disease.
Disclosures: Leng reports he serves as a medical advisor to Verana Health. Mbagwu reports he is a part-time consultant at Verana Health.
June 09, 2021
2 min read
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BLOG: Stand-alone MIGS procedures in the real world

Biography:

Theodore Leng, MD, MS, is a practicing retina specialist, associate professor of ophthalmology and director of clinical and translational research at the Byers Eye Institute at Stanford, Stanford University Medical School. He has a research background in image analysis, machine learning algorithms, and clinical trial design and execution.

Biography: Michael Mbagwu, MD, is a practicing comprehensive ophthalmologist at the VA Palo Alto Health Care System and is a current Byers Ophthalmic Innovation Fellow at the Byers Eye Institute at Stanford, Stanford University Medical School. He has a research interest in medical informatics, application of real-world data and creation of AI algorithms for diagnosis/prognosis of ophthalmic disease.
Disclosures: Leng reports he serves as a medical advisor to Verana Health. Mbagwu reports he is a part-time consultant at Verana Health.
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In June 2012, the iStent from Glaukos was approved by the FDA. Approval for the iStent inject followed in 2018.

Within the United States, both devices are indicated for use in conjunction with cataract surgery for reduction of IOP in patients with mild to moderate primary open-angle glaucoma. Procedures using these devices have been termed trabecular bypass microinvasive glaucoma surgeries (MIGS).

Theodore Leng
Michael Mbagwu

Although the iStent and iStent inject are indicated for use during cataract surgery, some surgeons have placed the stents in patients as a stand-alone procedure. However, the number and types of patients who have received stand-alone trabecular bypass MIGS surgery were previously not well characterized — until now.

The American Academy of Ophthalmology IRIS Registry data curation and analytics partner, Verana Health, analyzed de-identified data in the IRIS Registry to help researchers calculate the number of real-world patients who have undergone stand-alone trabecular bypass MIGS surgery. Glaukos sponsored the study and contributed to its design.

The data set in question runs from July 2013 to February 2020. Researchers winnowed down the number of trabecular bypass MIGS patients in the IRIS Registry from approximately 255,000 to approximately 187,000 who met the study criteria.

These 187,000 eyes in the IRIS Registry had known laterality and confirmed trabecular bypass MIGS. Eyes with a CPT code for cataract surgery and the code 0191T on the same day were considered combined patients, and patients with the code 0191T without a cataract surgery code on that day were considered stand-alone patients.

Of the 187,000 eyes we identified, approximately 1,000 eyes received stand-alone trabecular bypass MIGS procedures.

This real-world data deep dive yielded two major findings.

1. Stand-alone patients had more severe glaucoma than combined patients. Among patients who received stand-alone trabecular bypass MIGS procedures, nearly 21% had severe disease. Only about 7% of patients who received trabecular bypass MIGS combined with cataract surgery had severe disease.

2. Stand-alone patients had experienced more ocular surgery procedures before surgery. Patients who received stand-alone trabecular bypass MIGS procedures had significantly higher rates of previous cataract surgery, filtering and non-filtering glaucoma surgery, and laser procedures compared with patients in the combined surgery group.

These data tell us that approximately 1,000 trabecular bypass MIGS procedures have been performed in a stand-alone fashion from 2013 to 2020 and that a vast majority (99%) of trabecular bypass MIGS procedures have been performed in a combined surgery setting. Also, we know that those eyes that received stand-alone trabecular bypass MIGS procedures were more likely to have severe disease and to have had more prior ocular surgeries.

Quantifying the number of stand-alone trabecular bypass MIGS procedures was difficult when data were decentralized and disorganized. But, thanks to the real-world data stored in the IRIS Registry, we now have a data-based picture of real-world practice patterns.

  • References:
  • Chang R. Demographic and clinical characteristics of patients treated with MIGS, a TM-inserted stent, as a stand-alone procedure: An IRIS Registry retrospective cohort analysis. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).
  • Glaukos. iStent inject trabecular micro-bypass stent system [package insert].
  • Glaukos. iStent trabecular micro-bypass stent system [package insert].