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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-Invasive Glaucoma Surgical devices | Patients implanted With Micro-invasive Glaucoma Surgical (MIGS) devices at the National University Hospital, Singapore |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micro-invasive Glaucoma Surgical Devices | Device | Safety and efficacy of Micro-invasive Glaucoma Surgical Devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) reduction | IOP reduction at 12 months compared with baseline unmedicated IOP | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in topical glaucoma medication | Topical glaucoma medication use at 12 months, the incidence of complications and failure | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Glaucoma patients undergoing micro-invasive glaucoma surgical devices, with or without cataract surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chelvin Sng | Contact | +65 90083991 | chelvin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chelvin Sng | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelvin Sng, National University Hospital Department of Ophthalmology | Recruiting | Singapore | 119228 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25747677 | Background | 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. | |
| 31119690 |
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No plans to share IPD
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 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. |
| 22249233 | 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. |
| 26569527 | 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. |
| 26299720 | 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. |