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U. Altangerel, M.R. Moster, J.F. Lopes, M.G. Tong, H. Alvim, J. Fontanarosa; Healon5 Subtenon Under the Bleb in Trabeculectomy Surgery: A Randomized Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2005;46(13):127.
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Purpose: To investigate the effect of Healon5 (sodium hyaluronate 2.3%) application under the subtenons capsule at the conclusions of trabeculectomy surgery. Methods: Fifty–five patients, who were scheduled for trabeculectomy or combined cataract and trabeculectomy surgery, were randomized to receive either an injection of Healon5 under the subtenons capsule (28 patients) or balanced salt solution (27 patients) at the end of the procedure. The patients were examined at day one and then 1–3 weeks, 4–6 weeks, 3 months, 6 months and 1 year after surgery. Each examination included documentation of visual acuity, intraocular pressure (IOP), depth of the anterior chamber, inflammatory changes, and the status of the cornea, lens, retina, and optic nerve head. Photographic records of the filtering blebs were also documented. The morphologic characteristics of the bleb were evaluated using the guidelines outlined by Cantor. Blebs were considered favorable when in the range of low to moderate height (H1–2), with horizontal extent 1–3 clock hours (E1–3), being moderately avascular and with microcysts (V1). For the purpose of this study, total success was defined as intraocular pressure of ≤ 21 mm Hg without the use of glaucoma medication or any additional procedures; qualified success was defined as an intraocular pressure of ≤ 21 mm Hg with medication. Results: Fifty two patients completed the study. The IOP at 1 year did not differ significantly between the Healon5 (mean IOP=11.6±4.1mm Hg) and the BSS (13.2±4.2 mm Hg) groups (p=0.19). The IOP at 1 year postoperatively was statistically different from the baseline IOP levels in both groups (p=0.00). Success rate was similar for both groups (77.84% Healon5 and 84.0% BSS, p=0.57). IOP decreased by 50.5% in the Healon5 group and 39.1% in the BSS group (p=0.07). Fifty six and one half percent of Healon5 eyes and 42.9% of BSS eyes had blebs that were characterized as favorable overall (p=0.37). However, the Healon5 group showed more diffuse blebs than BSS eyes (65.2% ≥4 clock hours versus 22.7%), which was statistically significant (p=0.04). Conclusions: The subtenons use of Healon5 under the bleb at the Conclusions: of trabeculectomy surgery was associated with more diffuse blebs. However, the success rate and the IOP lowering effect were not statistically different between the two groups at one year after trabeculectomy. All other bleb characteristics were similar.
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