Study on Micro-invasive Glaucoma Surgical (MIGS) Devices

NCT04092400 | Unknown FDA Device

• 1 other identifier: DSRB - 2016/00125
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Glaucoma is an ocular condition in which optic nerve damage occurs, frequently in the presence of increased pressure within the eye. Micro-invasive glaucoma surgery (MIGS) refers to a new group of surgical procedures which are characterized by the following features: high safety profile, minimal trauma, ease of use and rapid recovery. There are 3 main groups of MIGS devices, which drain fluid to different regions in the eye: the Schlemm's canal, the suprachoroidal space and the subconjunctival space. Though MIGS devices were introduced in the United States of America, Canada and Europe more than 5 years ago, and have attained the CE mark and FDA approval for some devices. Studies have shown that these devices have a high safety profile and are effective (1-5). However, MIGS devices are only recently available in Asia, and data on their clinical outcomes in Asian patients are limited.

Conditions

Glaucoma

Keywords

Glaucoma; Glaucoma Surgery; Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP) reduction

  IOP reduction at 12 months compared with baseline unmedicated IOP

  12 months

Secondary Outcomes (1)

• Reduction in topical glaucoma medication

  12 months

Study Arms (1)

Micro-Invasive Glaucoma Surgical devices

Patients implanted With Micro-invasive Glaucoma Surgical (MIGS) devices at the National University Hospital, Singapore

Device: Micro-invasive Glaucoma Surgical Devices

Interventions

Micro-invasive Glaucoma Surgical Devices DEVICE

Safety and efficacy of Micro-invasive Glaucoma Surgical Devices

Micro-Invasive Glaucoma Surgical devices

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glaucoma patients undergoing micro-invasive glaucoma surgical devices, with or without cataract surgery

You may qualify if:

• are all patients with glaucoma who have been listed for implantation of micro-invasive glaucoma surgical devices, with or without cataract surgery

You may not qualify if:

• Advanced glaucoma (as defined as cup-disc ratio ≥ 0.9 and/or a visual field defect within central 10˚ of fixation) ; diagnosis of glaucoma other than POAG and PACG (including uveitic, neovascular, traumatic glaucoma or glaucoma secondary to raised episcleral venous pressure); prior incisional glaucoma surgery or cataract surgery; presence of scarring, prior surgery or other conjunctival pathologies in the target quadrant; presence of vitreous in the anterior chamber; presence of intraocular silicone oil; clinically significant inflammation or infection in the study eye within 30 days before the pre-operative visit; known or suspected allergy or sensitivity to drugs required for the surgery (including anaesthesia) or any of the device components (eg. porcine products and glutaraldehyde); and any corneal, choroidal, retinal, orbital disease which may interfere with MIGS device implantation

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

Chelvin Sng, National University Hospital Department of Ophthalmology

Singapore, 119228, Singapore

RECRUITING

Related Publications (5)

• Garcia-Feijoo J, Rau M, Grisanti S, Grisanti S, Hoh H, Erb C, Guguchkova P, Ahmed I, Grabner G, Reitsamer H, Shaarawy T, Ianchulev T. Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study. Am J Ophthalmol. 2015 Jun;159(6):1075-1081.e1. doi: 10.1016/j.ajo.2015.02.018. Epub 2015 Mar 3.

  PMID: 25747677 BACKGROUND

• Hengerer FH, Auffarth GU, Riffel C, Conrad-Hengerer I. Second-Generation Trabecular Micro-Bypass Stents as Standalone Treatment for Glaucoma: A 36-Month Prospective Study. Adv Ther. 2019 Jul;36(7):1606-1617. doi: 10.1007/s12325-019-00984-9. Epub 2019 May 22.

  PMID: 31119690 RESULT

• Saheb H, Ahmed II. Micro-invasive glaucoma surgery: current perspectives and future directions. Curr Opin Ophthalmol. 2012 Mar;23(2):96-104. doi: 10.1097/ICU.0b013e32834ff1e7.

  PMID: 22249233 RESULT

• Shah M, Law G, Ahmed II. Glaucoma and cataract surgery: two roads merging into one. Curr Opin Ophthalmol. 2016 Jan;27(1):51-7. doi: 10.1097/ICU.0000000000000224.

  PMID: 26569527 RESULT

• Ahmed II. MIGS and the FDA: What's in a Name? Ophthalmology. 2015 Sep;122(9):1737-9. doi: 10.1016/j.ophtha.2015.06.022. No abstract available.

  PMID: 26299720 RESULT

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Chelvin Sng

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelvin Sng

CONTACT

+65 90083991; chelvin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: September 17, 2019
• Study Start: March 10, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 14, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)