OBJECTIVES: To establish the relative safety and effectiveness of trabecular aspiration in combination with phacoemulsification and intraocular lens (IOL) implantation (asp+IOL) for decreasing intraocular pressure (IOP), and to compare the outcome of this method of treatment with that of phacoemulsification and IOL implantation alone (IOL-alone) or standard filtering glaucoma triple procedure (triple procedure). DESIGN: Prospective, controlled study randomized with respect to assignment to trabecular aspiration, with a case-control design between the asp+IOL and triple procedure groups. PARTICIPANTS: Seventy-four eyes of 74 patients with uncontrolled pseudoexfoliation glaucoma without a history of previous intraocular or extraocular surgery and in need of cataract surgery. Forty-eight patients were randomized to those receiving adjunctive trabecular aspiration (asp+IOL group of 26 eyes) and those given no trabecular aspiration (IOL-alone group of 22 eyes). The triple procedure group consisted of 26 cases, closely matched to the asp+IOL cases in terms of age, sex, cup-disc ratio, glaucoma medication requirements, and systemic diseases. INTERVENTIONS:Temporal clear corneal phacoemulsification and foldable IOL implantation was performed in all eyes. In the asp+IOL group, trabecular aspiration was performed with a suction force of 100 to 200 mm Hg under light tissue-instrument contact using a modified intraocular aspiration probe. A modified Cairns-type trabeculectomy without adjunctive antimetabolites was performed superiorly in the triple procedure eyes after IOL implantation. MAIN OUTCOME MEASURES: Surgical outcome was assessed in terms of IOP change, need of adjunctive glaucoma medication, visual acuity outcome, and complications. Surgical failure was defined as an outcome requiring additional surgical intervention or more than 1 medication to achieve IOP control to the target pressure. RESULTS: Two years after surgery, success rates were 36%, 64%, and 78% in the IOL-alone, asp+IOL, and triple procedure groups, respectively (P<.001). Hyphema (46%) and ocular hypotony (11%) were observed in the triple procedure group only, whereas blood reflux (61%) and descemetolysis (19%) were seen exclusively in the asp+IOL group. CONCLUSIONS: In pseudoexfoliative eyes, asp+IOL is significantly more effective than cataract surgery alone in reducing postoperative IOP and the necessity for glaucoma medication. Although trabecular aspiration in the triple procedure did not achieve pressure control in all patients, especially in the low target pressure range, the risk profile appears to be more favorable in the trabecular aspiration-treated eyes than in the filtering glaucoma triple procedure group. Trabecular aspiration in the glaucoma triple procedure could serve as a possible first-line treatment for pseudoexfoliative eyes with coexisting cataract and glaucoma.
RCT Entities:
OBJECTIVES: To establish the relative safety and effectiveness of trabecular aspiration in combination with phacoemulsification and intraocular lens (IOL) implantation (asp+IOL) for decreasing intraocular pressure (IOP), and to compare the outcome of this method of treatment with that of phacoemulsification and IOL implantation alone (IOL-alone) or standard filtering glaucoma triple procedure (triple procedure). DESIGN: Prospective, controlled study randomized with respect to assignment to trabecular aspiration, with a case-control design between the asp+IOL and triple procedure groups. PARTICIPANTS: Seventy-four eyes of 74 patients with uncontrolled pseudoexfoliation glaucoma without a history of previous intraocular or extraocular surgery and in need of cataract surgery. Forty-eight patients were randomized to those receiving adjunctive trabecular aspiration (asp+IOL group of 26 eyes) and those given no trabecular aspiration (IOL-alone group of 22 eyes). The triple procedure group consisted of 26 cases, closely matched to the asp+IOL cases in terms of age, sex, cup-disc ratio, glaucoma medication requirements, and systemic diseases. INTERVENTIONS: Temporal clear corneal phacoemulsification and foldable IOL implantation was performed in all eyes. In the asp+IOL group, trabecular aspiration was performed with a suction force of 100 to 200 mm Hg under light tissue-instrument contact using a modified intraocular aspiration probe. A modified Cairns-type trabeculectomy without adjunctive antimetabolites was performed superiorly in the triple procedure eyes after IOL implantation. MAIN OUTCOME MEASURES: Surgical outcome was assessed in terms of IOP change, need of adjunctive glaucoma medication, visual acuity outcome, and complications. Surgical failure was defined as an outcome requiring additional surgical intervention or more than 1 medication to achieve IOP control to the target pressure. RESULTS: Two years after surgery, success rates were 36%, 64%, and 78% in the IOL-alone, asp+IOL, and triple procedure groups, respectively (P<.001). Hyphema (46%) and ocular hypotony (11%) were observed in the triple procedure group only, whereas blood reflux (61%) and descemetolysis (19%) were seen exclusively in the asp+IOL group. CONCLUSIONS: In pseudoexfoliative eyes, asp+IOL is significantly more effective than cataract surgery alone in reducing postoperative IOP and the necessity for glaucoma medication. Although trabecular aspiration in the triple procedure did not achieve pressure control in all patients, especially in the low target pressure range, the risk profile appears to be more favorable in the trabecular aspiration-treated eyes than in the filtering glaucoma triple procedure group. Trabecular aspiration in the glaucoma triple procedure could serve as a possible first-line treatment for pseudoexfoliative eyes with coexisting cataract and glaucoma.
Authors: André Rosentreter; Sven Dinslage; Günter K Krieglstein; Thomas S Dietlein Journal: Graefes Arch Clin Exp Ophthalmol Date: 2009-08-21 Impact factor: 3.117