Glaucoma — Deep Sclerectomy vs Xen in Solo Procedure
Citation(s)
Eldaly MA, Bunce C, Elsheikha OZ, Wormald R Non-penetrating filtration surgery versus trabeculectomy for open-angle glaucoma. Cochrane Database Syst Rev. 2014 Feb 15;(2):CD007059. doi: 10.1002/14651858.CD007059.pub2.
GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e144-e160. doi: 10.1016/S2214-109X(20)30489-7. Epub 2020 Dec 1. Erratum In: Lancet Glob Health. 2021 Apr;9(4):e408.
Touboul A, Fels A, Morin A, Bensmail D, Lachkar Y One-Year Outcomes of Standalone XEN Gel Stent Versus Nonpenetrating Deep Sclerectomy. J Glaucoma. 2022 Dec 1;31(12):955-965. doi: 10.1097/IJG.0000000000002108. Epub 2022 Aug 22.
Deep Sclerectomy vs Xen in Solo Procedure: Comparative Study, Efficacy and Safety Profile
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
