Special Commentary: Reporting Clinical Endpoints in Studies of Minimally Invasive Glaucoma Surgery.

Autor:	Gedde SJ; Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida., Vinod K; Department of Ophthalmology, Icahn School of Medicine at Mount Sinai and New York Eye and Ear Infirmary of Mount Sinai, New York, New York., Bowden EC; Mitchel and Shannon Wong Eye Institute, Dell Medical School at the University of Texas at Austin, Austin, Texas., Kolomeyer NN; Wills Eye Hospital, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania., Chopra V; Doheny and Stein Eye Institutes, David Geffen School of Medicine at UCLA, Los Angeles, California., Challa P; Department of Ophthalmology, Duke University, Durham, North Carolina., Budenz DL; Department of Ophthalmology, University of North Carolina, Chapel Hill, North Carolina., Repka MX; Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland., Lum F; American Academy of Ophthalmology, San Francisco, California. Electronic address: flum@aao.org.
Jazyk:	angličtina
Zdroj:	Ophthalmology [Ophthalmology] 2024 Aug 08. Date of Electronic Publication: 2024 Aug 08.
DOI:	10.1016/j.ophtha.2024.07.030
Abstrakt:	Minimally invasive glaucoma surgery (MIGS) refers to a group of procedures generally characterized by an ab interno approach, minimal trauma to ocular tissue, moderate efficacy, an excellent safety profile, and rapid recovery. The number of MIGS procedures continues to increase, and their use has become widespread among glaucoma and cataract specialists. Standardization of the methodology and reporting of clinical endpoints in MIGS investigations enhances interpretation and comparison across different studies. The assessment of surgical interventions not only should consider statistical significance, but also whether the outcome is meaningful to patients. Minimal clinically important difference (MCID) is defined as the smallest change in a treatment outcome that is considered beneficial for an individual patient and prompts a change in their clinical management. Expert consensus is an accepted approach to determine the MCID. The American Academy of Ophthalmology's Glaucoma Preferred Practice Pattern® Committee is an expert panel that develops guidelines identifying characteristics and components of quality eye care. The Committee recommends that the cumulative probability of surgical success at 2 years with Kaplan-Meier survival analysis be used as the primary efficacy endpoint in MIGS studies. The Committee suggests that surgical success for standalone MIGS be defined as intraocular pressure (IOP) of 21 mmHg or less and reduced by 20% or more from baseline without an increase in glaucoma medications, additional laser or incisional glaucoma surgery, loss of light perception vision, or hypotony. The proposed MCID for the cumulative probability of success of standalone MIGS at 2 years is 50%. The panel recommends that surgical success for MIGS combined with cataract extraction with intraocular lens implantation (CE-IOL) be defined as a decrease in glaucoma medical therapy of 1 medication or more from baseline without an increase in IOP or IOP of 21 mmHg or less and reduced by 20% or more from baseline without an increase in glaucoma medications, additional laser or incisional glaucoma surgery, loss of light perception vision, or hypotony. The suggested MCID for the cumulative probability of success for MIGS combined with CE-IOL at 2 years is 65%. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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