Study on Micro-invasive Glaucoma Surgical (MIGS) Devices

Glaucoma Clinical Trial

Official title:

Prospective Observational Study of Patients Implanted With Micro-invasive Glaucoma Surgical (MIGS) Devices at the National University Hospital, Singapore

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092400
• Other study ID #: DSRB - 2016/00125
• Status: Recruiting
• Start date: March 10, 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: National University Hospital, Singapore
• Contact: Chelvin Sng
• Phone: +65 90083991
• Email: chelvin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Micro-invasive Glaucoma Surgical Devices
Safety and efficacy of Micro-invasive Glaucoma Surgical Devices

Locations

Country	Name	City	State
Singapore	Chelvin Sng, National University Hospital Department of Ophthalmology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (5)

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. — View Citation

García-Feijoo J, Rau M, Grisanti S, Grisanti S, Höh 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. — View Citation

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 — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure (IOP) reduction	IOP reduction at 12 months compared with baseline unmedicated IOP	12 months
Secondary	Reduction in topical glaucoma medication	Topical glaucoma medication use at 12 months, the incidence of complications and failure	12 months