- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04092400
Study on Micro-invasive Glaucoma Surgical (MIGS) Devices
Prospective Observational Study of Patients Implanted With Micro-invasive Glaucoma Surgical (MIGS) Devices at the National University Hospital, Singapore
Study Overview
Status
Conditions
Intervention / Treatment
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)
- 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chelvin Sng
- Phone Number: +65 90083991
- Email: chelvin@gmail.com
Study Locations
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-
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Singapore, Singapore, 119228
- Recruiting
- Chelvin Sng, National University Hospital Department of Ophthalmology
-
Contact:
- Chelvin Sng
- Phone Number: 90083991
- Email: chelvin@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Micro-Invasive Glaucoma Surgical devices
Patients implanted With Micro-invasive Glaucoma Surgical (MIGS) devices at the National University Hospital, Singapore
|
Safety and efficacy of Micro-invasive Glaucoma Surgical Devices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular pressure (IOP) reduction
Time Frame: 12 months
|
IOP reduction at 12 months compared with baseline unmedicated IOP
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in topical glaucoma medication
Time Frame: 12 months
|
Topical glaucoma medication use at 12 months, the incidence of complications and failure
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chelvin Sng, National University Hospital, Singapore
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSRB - 2016/00125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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