Things Go Better with Cataract Surgery
2014; Elsevier BV; Volume: 121; Issue: 1 Linguagem: Inglês
10.1016/j.ophtha.2013.08.001
ISSN1549-4713
Autores Tópico(s)Ophthalmology and Eye Disorders
ResumoIn 1965, the largest beverage company in the world came up with the slogan: “Things go better with Coke.” Although very little has changed regarding the choice of, and techniques pertaining to, stand-alone glaucoma surgery, the past few years have brought us a multitude of novel intraocular pressure (IOP)-lowering procedures that are being used in combination with cataract surgery, an operation that is known to provide sustained lowering of IOP for at least 3 years.1Choi D.Y. Suramethakul P. Lindstrom R.L. Singh K. Glaucoma surgery with or without cataract surgery, revolution or evolution.J Cataract Refract Surg. 2012; 38: 1121-1122Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar, 2Mansberger S.L. Gordon M.O. Jampel H. et al.Reduction in intraocular pressure after cataract extraction: the Ocular Hypertension Treatment Study.Ophthalmology. 2012; 119: 1826-1831Abstract Full Text Full Text PDF PubMed Scopus (195) Google Scholar So although trabeculectomy and drainage device implantation remain the mainstays of conventional stand-alone surgery for those who are “refractory” to medical and laser therapy, a wave of potentially safer procedures are being introduced for combination with cataract surgery for “nonrefractory” patients.Glaucoma care presents the “perfect storm” when it comes to the possibility of ineffective therapies being deemed to be effective based on a variety of factors related to the imperfection of IOP measurement combined with other factors, such as investigator unmasking of treated groups. If these limitations were not enough, we are now inundated with novel glaucoma therapies that are being combined with an effective IOP-lowering procedure: Modern phacoemulsification of the lens and posterior chamber intraocular lens implantation. It is common to hear study data presented at meetings that describe the IOP-lowering effect of such novel glaucoma procedures combined with cataract surgery, without a cataract surgery alone comparator arm that would be necessary to assess the incremental benefit of the glaucoma procedure. It seems that every new glaucoma procedure can lower the IOP to the mid to high teens when combined with cataract surgery with little emphasis on the fact that this reduction is largely due to the cataract procedure. Fortunately, regulatory agencies are now requiring a cataract surgery only arm for purposes of comparison when novel operative approaches are combined with cataract surgery. Future glaucoma device approvals will undoubtedly not only require evidence of safety, but also clear standards of what constitutes adequate efficacy.Although all novel glaucoma procedures seem better with cataract surgery, some are undoubtedly better than others. Purists may insist that evaluation of any novel glaucoma procedure being proposed as an adjunct to cataract surgery should also be studied as a stand-alone glaucoma operation so as to not conceal the possible lack of efficacy of the novel therapy, with adjunctive phacoemulsification. Nevertheless, it is hard to argue against the benefit of a safe glaucoma procedure that can lower IOP 2–3 mmHg beyond phacoemulsification alone in a substantial proportion of those being treated, regardless of how ineffective the procedure may be as a stand-alone operation. There should be some minimum standard for additivity, comparable with that used in assessing glaucoma medications used adjunctively with gold standards such as prostaglandin analogs, for us to adopt novel glaucoma operative procedures combined with cataract surgery. Just as adding third and fourth glaucoma medications for IOP lowering may not be justified from a risk–benefit–cost standpoint, proceeding with a glaucoma surgical option with a very low likelihood of additivity to cataract surgery alone will, at the very least, unnecessarily add to health care costs, and in the worse case, put patients at risk that is not justified by the potential benefit. In 1965, the largest beverage company in the world came up with the slogan: “Things go better with Coke.” Although very little has changed regarding the choice of, and techniques pertaining to, stand-alone glaucoma surgery, the past few years have brought us a multitude of novel intraocular pressure (IOP)-lowering procedures that are being used in combination with cataract surgery, an operation that is known to provide sustained lowering of IOP for at least 3 years.1Choi D.Y. Suramethakul P. Lindstrom R.L. Singh K. Glaucoma surgery with or without cataract surgery, revolution or evolution.J Cataract Refract Surg. 2012; 38: 1121-1122Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar, 2Mansberger S.L. Gordon M.O. Jampel H. et al.Reduction in intraocular pressure after cataract extraction: the Ocular Hypertension Treatment Study.Ophthalmology. 2012; 119: 1826-1831Abstract Full Text Full Text PDF PubMed Scopus (195) Google Scholar So although trabeculectomy and drainage device implantation remain the mainstays of conventional stand-alone surgery for those who are “refractory” to medical and laser therapy, a wave of potentially safer procedures are being introduced for combination with cataract surgery for “nonrefractory” patients. Glaucoma care presents the “perfect storm” when it comes to the possibility of ineffective therapies being deemed to be effective based on a variety of factors related to the imperfection of IOP measurement combined with other factors, such as investigator unmasking of treated groups. If these limitations were not enough, we are now inundated with novel glaucoma therapies that are being combined with an effective IOP-lowering procedure: Modern phacoemulsification of the lens and posterior chamber intraocular lens implantation. It is common to hear study data presented at meetings that describe the IOP-lowering effect of such novel glaucoma procedures combined with cataract surgery, without a cataract surgery alone comparator arm that would be necessary to assess the incremental benefit of the glaucoma procedure. It seems that every new glaucoma procedure can lower the IOP to the mid to high teens when combined with cataract surgery with little emphasis on the fact that this reduction is largely due to the cataract procedure. Fortunately, regulatory agencies are now requiring a cataract surgery only arm for purposes of comparison when novel operative approaches are combined with cataract surgery. Future glaucoma device approvals will undoubtedly not only require evidence of safety, but also clear standards of what constitutes adequate efficacy. Although all novel glaucoma procedures seem better with cataract surgery, some are undoubtedly better than others. Purists may insist that evaluation of any novel glaucoma procedure being proposed as an adjunct to cataract surgery should also be studied as a stand-alone glaucoma operation so as to not conceal the possible lack of efficacy of the novel therapy, with adjunctive phacoemulsification. Nevertheless, it is hard to argue against the benefit of a safe glaucoma procedure that can lower IOP 2–3 mmHg beyond phacoemulsification alone in a substantial proportion of those being treated, regardless of how ineffective the procedure may be as a stand-alone operation. There should be some minimum standard for additivity, comparable with that used in assessing glaucoma medications used adjunctively with gold standards such as prostaglandin analogs, for us to adopt novel glaucoma operative procedures combined with cataract surgery. Just as adding third and fourth glaucoma medications for IOP lowering may not be justified from a risk–benefit–cost standpoint, proceeding with a glaucoma surgical option with a very low likelihood of additivity to cataract surgery alone will, at the very least, unnecessarily add to health care costs, and in the worse case, put patients at risk that is not justified by the potential benefit. Lack of a Visible Outcome Marker Fuels the Perfect Storm of Dr Singh's EditorialOphthalmologyVol. 121Issue 2PreviewDr Singh's recent editorial1 entitled “Things Go Better with Cataract Surgery” points out that glaucoma care is unique in that there are inherent difficulties of measurement endpoints, inaccuracies of psychophysical testing, and confounding study variables such as intraocular pressure (IOP) reduction from cataract surgery, to name a few. These inadequacies, partly the basis for his perfect storm scenario regarding device studies, are conducive to study bias as he mentions, but that certainly is not completely the fault of scientists, CEOs, or physicians. Full-Text PDF
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