Abstract
In the United States, the Food and Drug Administration (FDA) regulates the commercialization of devices intended to reduce intraocular pressure (IOP). Depending on the nature of the technology, the indications for use, and the claims being made by the company marketing the device, devices used to lower IOP may be class I (exempt from a 510(k) submission), class II requiring FDA clearance, or class III requiring FDA approval via a premarket application. The FDA evaluates medical devices using information provided by the sponsor of the submission. Among the types of evidence that may be required, clinical investigations involving human subjects may be required to provide reasonable assurance that a device is safe and effective for its intended use. Clinical data provided in support of any FDA marketing application should fit the definition of “valid scientific evidence”; thus, an appropriate trial design is essential to be able to legally market a device for IOP reduction in the United States.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
- 2.
Defined as eyes with “patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed”.
- 3.
Defined in the guidance as eyes “with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed”.
- 4.
Defined in the ANSI standard as “eyes uncontrolled by medical therapy and diagnosed with glaucoma which meet at least one of the following criteria:
1. Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt)
2. Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
3. Have neovascular glaucoma
4. Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for an eye with uncomplicated primary open-angle glaucoma”
- 5.
Defined in the ANSI standard as “eyes diagnosed with glaucoma which do not meet any of the criteria for refractory glaucoma and which may have or may not have been treated with medications or laser trabeculoplasty. It includes eyes with glaucoma that are candidates for medical therapy, laser treatment, and glaucoma filtering surgery. Eyes in this category may have undergone uncomplicated cataract surgery, retinal laser, or extraocular muscle surgery.”
- 6.
N.B. The ANSI standard for implantable glaucoma devices has yet to be formally recognized by FDA as of May 2013.
References
U.S. Food and Drug Administration 510(k) Premarket Notification Database. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Updated 3 May 2013.
U.S. Food and Drug Administration Guidance for Industry and for FDA Reviewers/Staff: Aqueous Shunts – 510(k) Submissions. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073806.htm. Updated 16 Nov 1998.
Ex-Press Miniature Glaucoma Implant, Models R-20, R-30, R-50 STS Versions: Optonol, Ltd. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf/K012852.pdf. Updated 3 May 2013.
STAAR Surgical Company AquaFlow Collagen Glaucoma Drainage Device Model CGDD-20 – P000026. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p000026. Updated 27 Aug 2001.
Glaukos iStent® Trabecular Micro-Bypass Stent (Models GTS-00R, GTS-100L) and Inserter (GTS-100i) – P080030. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P080030. Updated 16 July 2012.
U.S. Department of Health and Human Services Food and Drug Administration. Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: significant risk and nonsignificant risk medical device studies. Available from: http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126418.pdf. Updated Jan 2006.
U.S. Food and Drug Administration 21 CFR 860.7 – Code of Federal Regulations Title 21, (Volume 8) Food and Drugs, Chapter 1 – Food and Drug Administration Department of Health and Human Services Subchapter H – Medical Devices – Part 860- Medical Device Classification Procedures- Subpart A- General, Section 860.7 Determination of safety and effectiveness. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=860.7. Updated 1 Apr 2012.
Francis BA, Singh K, Lin SC, Hodapp E, Jampel HD, Samples JR, et al. Novel glaucoma procedures: a report by the American Academy of Ophthalmology. Ophthalmology. 2011;118:1466–80. doi:10.1016/j.ophtha.2011.03.028. PubMed PMID 21724045. Available from http://www.ncbi.nlm.nih.gov/pubmed/21724045.
Weinreb RN, Kaufman PL. The glaucoma research community and FDA look to the future: a report from the NEI/FDA CDER Glaucoma Clinical Trial Design and Endpoints Symposium. Invest Ophthalmol Vis Sci. 2009;50(4):1497–505. doi:10.1167/ivos.08-2843.
Parrish RK, Minckler DS, Lam D, Pfeifffer N, RojanaPongpun P. Recommended methodology for glaucoma surgical trials. The Hague/Amsterdam/The Netherlands: Kugler Publications; 2008.
CONSORT Statement Website. Available from: http://www.consort-statement.org/. Updated 20 Jan 2012.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer Science+Business Media New York
About this chapter
Cite this chapter
Gordon, J.F., Kramm, R.L. (2014). Clinical Trials for IOP-Lowering Devices to Support an FDA Premarket Submission. In: Samples, J.R., Ahmed, I.I.K. (eds) Surgical Innovations in Glaucoma. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-8348-9_5
Download citation
DOI: https://doi.org/10.1007/978-1-4614-8348-9_5
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4614-8347-2
Online ISBN: 978-1-4614-8348-9
eBook Packages: MedicineMedicine (R0)