Status:
UNKNOWN
Study on Micro-invasive Glaucoma Surgical (MIGS) Devices
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
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 sur...
Detailed Description
* Data will be collected for 5 years after surgery, and the data collected will be the routine examination findings and investigations before and after surgery (as part of standard medical treatment) ...
Eligibility Criteria
Inclusion
- are all patients with glaucoma who have been listed for implantation of micro-invasive glaucoma surgical devices, with or without cataract surgery
Exclusion
- 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
Key Trial Info
Start Date :
March 10 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04092400
Start Date
March 10 2016
End Date
December 1 2020
Last Update
November 14 2019
Active Locations (1)
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1
Chelvin Sng, National University Hospital Department of Ophthalmology
Singapore, Singapore, 119228