Study on Micro-invasive Glaucoma Surgical (MIGS) Devices

Sponsor
National University Hospital, Singapore (Other)
Overall Status
Unknown status
CT.gov ID
NCT04092400
Collaborator
(none)
500
1
56.7
8.8

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Micro-invasive Glaucoma Surgical Devices

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Observational Study of Patients Implanted With Micro-invasive Glaucoma Surgical (MIGS) Devices at the National University Hospital, Singapore
Actual Study Start Date :
Mar 10, 2016
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Micro-Invasive Glaucoma Surgical devices

Patients implanted With Micro-invasive Glaucoma Surgical (MIGS) devices at the National University Hospital, Singapore

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

Outcome Measures

Primary Outcome Measures

  1. Intraocular pressure (IOP) reduction [12 months]

    IOP reduction at 12 months compared with baseline unmedicated IOP

Secondary Outcome Measures

  1. Reduction in topical glaucoma medication [12 months]

    Topical glaucoma medication use at 12 months, the incidence of complications and failure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chelvin Sng, National University Hospital Department of Ophthalmology Singapore Singapore 119228

Sponsors and Collaborators

  • National University Hospital, Singapore

Investigators

  • Principal Investigator: Chelvin Sng, National University Hospital, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT04092400
Other Study ID Numbers:
  • DSRB - 2016/00125
First Posted:
Sep 17, 2019
Last Update Posted:
Nov 14, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by National University Hospital, Singapore
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2019