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• W4252562531 abstract "We thank Yap et al for their interest in our article. The primary outcome measure in the Primary Tube Versus Trabeculectomy Study was the cumulative rate of surgical failure.1Gedde S.J. Feuer W.J. Lim K.S. et al.Treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) study after 3 years of follow-up.Ophthalmology. 2020; 127: 333-345Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar Failure was defined prospectively as an intraocular pressure (IOP) of >21 mmHg or reduced by <20% from baseline on 2 consecutive follow-up visits after 3 months, an IOP of ≤5 mmHg on 2 consecutive visits after 3 months, reoperation for glaucoma, or loss of light perception vision. Eyes that did not fail by these criteria were considered successes. Our definitions of failure and success are consistent with recommendations from the World Glaucoma Association for the reporting of outcomes of glaucoma surgical trials.2Heuer D.K. Barton K. Grehn F. et al.Consensus on definitions of success.in: Shaarawy T.M. Sherwood M.B. Grehn F. Guidelines on Design and Reporting of Surgical Trials. Kugler, Amsterdam2008: 15-24Google Scholar Yap et al have recognized the difficulty in using only an upper IOP level to define success and failure, especially in patients with a low preoperative IOP. For example, omitting the requirement for a percentage reduction in IOP from our definition of failure means that a patient with a preoperative IOP of 18 mmHg and a postoperative IOP of 20 mmHg would be classified as a success. Given the fact that the IOP actually increased after surgical intervention, it is difficult to accept this as a successful outcome. Alternative “conditional” criteria for failure have been suggested, which essentially remove an upper IOP level and use only a 20% reduction from baseline to define success and failure. However, this approach is problematic, especially in patients with a high preoperative IOP. A decrease in IOP from 50 to 40 mmHg represents a 20% reduction, but this degree of pressure lowering does not seem adequate to allow categorization as a surgical success. It is desirable to include both an upper IOP limit and a percentage reduction from baseline when defining success and failure, as has been advocated by the World Glaucoma Association in reporting the results of glaucoma surgical trials. The ideal measure of success of any glaucoma therapy, whether medical or surgical, is the prevention of further glaucomatous optic nerve damage and visual field loss. There are difficulties in defining success by an arbitrary IOP level or percentage reduction in IOP, because individual patients vary in the susceptibility of their optic nerves to the damaging effect of IOP. Nevertheless, IOP reduction is the goal of glaucoma therapy, and IOP is a reflection of the efficacy of treatment. Our definitions of success and failure are similar to previous studies involving the surgical treatment of glaucoma, thereby facilitating comparisons with published results.3The Fluorouracil Filtering Surgery Study GroupFive-year follow-up of the Fluorouracil Filtering Surgery Study.Am J Ophthalmol. 1996; 121: 349-366Abstract Full Text PDF PubMed Scopus (392) Google Scholar, 4Gedde S.J. Schiffman J.C. Feuer W.J. et al.Treatment outcomes in the Tube Versus Trabeculectomy (TVT) Study after five years of follow-up.Am J Ophthalmol. 2012; 153: 789-803Abstract Full Text Full Text PDF PubMed Scopus (617) Google Scholar, 5Budenz D.L. Barton K. Gedde S.J. et al.Five-year treatment outcomes in the Ahmed Baerveldt Comparison Study.Ophthalmology. 2015; 122: 308-316Abstract Full Text Full Text PDF PubMed Scopus (154) Google Scholar We appreciate the correspondence from Yap et al. It has allowed us to discuss some of the challenges involved with defining outcomes in glaucoma surgical trials. Re: Gedde et al.: Treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) study after 3 years of follow-up (Ophthalmology. 2020;127:333–345)OphthalmologyVol. 127Issue 9PreviewFailure and success criteria according to intraocular pressure measurements are often used in glaucoma trials1 to analyze the longevity and comparative success of surgical interventions. This is in accordance with the World Glaucoma Association “Guidelines on Design and Reporting of Glaucoma Surgical Trials,” advocating for prospectively stated criteria on which to base analyses.2 Other trials have used targets that are relative to the degree of visual field defect, relevant on a per-patient basis, but not an absolute reflection of the intraocular pressure (IOP)-lowering usefulness of the procedure. Full-Text PDF" @default.
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