PURPOSE: To determine the incidence and timing of increased intraocular pressure in eyes with an idiopathic macular hole treated with bovine transforming growth factor-beta 2 (TGF-beta 2) with different intraocular gas concentrations, recombinant TGF-beta 2, or placebo. METHODS:Intraocular pressure was measured preoperatively and two days, two weeks, six weeks, and three months postoperatively in two prospective studies of the treatment of idiopathic macular hole with vitrectomy. Group 1 consisted of 95 eyes treated with bovine TGF-beta 2. Eyes in this group were treated with different concentrations of air and perfluoropropane (C3F8) intraocular gas bubbles. Fifteen eyes were treated with air, 15 eyes with 5% perfluoropropane, 15 eyes with 10% perfluoropropane, and 50 eyes with 16% perfluoropropane. Group 2 consisted of 29 eyes treated with recombinant TGF-beta 2. Twenty-six eyes were treated withplacebo in a double-masked, randomized, placebo-controlled study evaluating recombinant TGF-beta 2 with a 16% perfluoropropane intraocular gas bubble. RESULTS: At the two-week examination, the intraocular pressure in Group 1 eyes was > 30 mm Hg in four (26.7%) of 15 eyes treated with air, two (13.3%) of 15 eyes treated with 5% perfluoropropane, one (8.3%) of 12 eyes treated with 10% perfluoropropane, and nine (19.1%) of 47 eyes treated with 16% perfluoropropane. There was no statistically significant difference in the risk of increased intraocular pressure in eyes treated with short-, intermediate-, or long-duration gas tamponade using bovine TGF-beta 2. The intraocular pressure in Group 2 was > 30 mm Hg at the two-week examination in 11 (39.3%) of 28 eyes receiving recombinant TGF-beta 2 compared with one (4.3%) of 23 eyes receiving a placebo (P = .006). CONCLUSIONS: Some eyes develop increased intraocular pressure after vitreous surgery for macular hole, and the increase occurs most frequently between two days and two weeks postoperatively. The risk of increased intraocular pressure is somewhat increased in eyes treated with bovine TGF-beta 2 but is markedly increased in eyes in which recombinant TGF-beta 2 is used as an adjunctive agent for macular hole surgery. Intraocular injection of growth factors produced by similar recombinant DNA techniques may result in potentially dangerous increased intraocular pressure several weeks after surgery. Impurities in the recombinant TGF-beta 2 may explain the relatively high risk of increased intraocular pressure.
RCT Entities:
PURPOSE: To determine the incidence and timing of increased intraocular pressure in eyes with an idiopathic macular hole treated with bovinetransforming growth factor-beta 2 (TGF-beta 2) with different intraocular gas concentrations, recombinant TGF-beta 2, or placebo. METHODS: Intraocular pressure was measured preoperatively and two days, two weeks, six weeks, and three months postoperatively in two prospective studies of the treatment of idiopathic macular hole with vitrectomy. Group 1 consisted of 95 eyes treated with bovineTGF-beta 2. Eyes in this group were treated with different concentrations of air and perfluoropropane (C3F8) intraocular gas bubbles. Fifteen eyes were treated with air, 15 eyes with 5% perfluoropropane, 15 eyes with 10% perfluoropropane, and 50 eyes with 16% perfluoropropane. Group 2 consisted of 29 eyes treated with recombinant TGF-beta 2. Twenty-six eyes were treated with placebo in a double-masked, randomized, placebo-controlled study evaluating recombinant TGF-beta 2 with a 16% perfluoropropane intraocular gas bubble. RESULTS: At the two-week examination, the intraocular pressure in Group 1 eyes was > 30 mm Hg in four (26.7%) of 15 eyes treated with air, two (13.3%) of 15 eyes treated with 5% perfluoropropane, one (8.3%) of 12 eyes treated with 10% perfluoropropane, and nine (19.1%) of 47 eyes treated with 16% perfluoropropane. There was no statistically significant difference in the risk of increased intraocular pressure in eyes treated with short-, intermediate-, or long-duration gas tamponade using bovineTGF-beta 2. The intraocular pressure in Group 2 was > 30 mm Hg at the two-week examination in 11 (39.3%) of 28 eyes receiving recombinant TGF-beta 2 compared with one (4.3%) of 23 eyes receiving a placebo (P = .006). CONCLUSIONS: Some eyes develop increased intraocular pressure after vitreous surgery for macular hole, and the increase occurs most frequently between two days and two weeks postoperatively. The risk of increased intraocular pressure is somewhat increased in eyes treated with bovineTGF-beta 2 but is markedly increased in eyes in which recombinant TGF-beta 2 is used as an adjunctive agent for macular hole surgery. Intraocular injection of growth factors produced by similar recombinant DNA techniques may result in potentially dangerous increased intraocular pressure several weeks after surgery. Impurities in the recombinant TGF-beta 2 may explain the relatively high risk of increased intraocular pressure.
Authors: H Hoerauf; H Klüter; E Joachimmeyer; J Roider; C Framme; P Schlenke; H Kirchner; H Lagua Journal: Int Ophthalmol Date: 2001 Impact factor: 2.031