Study on Micro-invasive Glaucoma Surgical (MIGS) Devices
Study on Micro-invasive Glaucoma Surgical (MIGS) Devices
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.
-  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)

 -  Visual acuity testing, refraction, humphrey perimetry, heidelberg retinal tomography,
 anterior segment optical coherence tomography, pre-operative endothelial cell count,
 corneal pachymetry, intraocular pressure measurement, number of glaucoma medications

 -  A log will be used to keep track of subject's wishes on the return for incidental
 findings (IF) according to subject's choice during the signing of consent form (however,
 we do not anticipate any incidental findings related to the study as this is an
 observational and non-interventional study).

 -  In case of return incidental finding for subject who consented, PI will inform the
 research subject, or his legally authorised representatives, information and feedback on
 IFs.

 -  PI with sufficient time for explanation and for the research subject to ask questions.

 -  Sufficient information will be provided to the research subject or his legally
 authorised representative so that he can make an informed decision as to whether to
 return to the Institution for medical consultation, seek an opinion elsewhere, or to
 have no follow-up action with regards to the IF.

 Sample size and power calculations are not applicable as this observational study involves
 Medical Records Review and is not an interventional study.The recruitment target of 500 is
 based on the upper limit of the estimated number of patients who will undergo micro-invasive
 glaucoma surgical device implantation during the study period, though it is likely to be an
 overestimation. Pre-operative intraocular pressure and number of glaucoma medications will be
 compared with post-operative intraocular pressure and number of glaucoma medications at one
 year, 2 years, 3 years, 4 years and 5 years after surgery, using the paired t-test.
 Statistical significance is set at p<0.05

 All activities involving the patient will be performed as part of the routine diagnostic or
 standard medical treatment as part of the subject's standard care. This is an observational
 study and no activities outside standard care will be performed as part of this study.The
 activities not involving the patient includes screening, data collection, data analysis.
Inclusion Criteria:

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

 Exclusion Criteria:

 -  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