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Table 8-138Trabeculectomy + pharmacological augmentation vs. trabeculectomy - Clinical study characteristics

OutcomeNumber of studiesDesignLimitationsInconsistencyDirectnessOther considerations
Visual field progression0
Mean change in IOP from baseline0
Number of patients with an unacceptable IOP (follow up 12 months) 26,39,49,94,113,118,123, 1478RCT (a)Serious limitations (b)No serious inconsistencyNo serious indirectnessNo serious imprecision
Additional notes (d)
Complications: Cataract Formation (follow up 9–18 months)26,39,49,88,94,118,123,1478RCT (a)Serious limitations (b)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Additional notes (d)
Complications: Persistent hypotony (follow up 9–18 months)26,39,49,88,94,118,1477RCT (a)Serious limitations (b)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Additional notes (d)
Complications: Wound leak (follow up 9–18 months)26,39,49,88,118,1476RCT (a)Serious limitations (b)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Additional notes (d)
Complications: Corneal epithelial defects (follow up 9–18 months)39,49,88,113, 1475RCT (a)Serious limitations (b)No serious inconsistencyNo serious indirectnessSerious imprecision (c)
Additional notes (d)
a

Studies are supplemented by data from the Cochrane systematic reviews Wilkins 2005161 and Wormald 2001162.

b

For the antimetabolite MMC: 3 studies do not report details of randomisation method26,123,147. 3 studies do not report details of allocation concealment94,118,147. 3 studies do not report masking of outcome assessment26,118,147. Only 2 studies were placebo controlled26,147. For the antimetabolite 5-FU: 2 studies do not report details of randomisation method39,113. 3 studies do not report details of allocation concealment, masking of outcome assessment and are not placebo controlled39,49,113. One study88 is a placebo controlled double blind design.

c

Wide confidence intervals making estimate of effect uncertain.

d

Although there is no statistical heterogeneity observed other differences between studies are noted in type of antimetabolite (MMC or 5-FU) used and dosage, delivery method of 5-FU (intraoperative or postoperative injections), IOP failure criteria, length of follow up, reporting of complications, proportion of patients with closed-angle glaucoma of <50%, mean baseline IOP and whether patients received previous laser treatment. One study39 is exclusively in Afro-Caribbean patients and one study123 is exclusively in patients from the Indian sub-continent.

Studies are supplemented by data from the Cochrane systematic reviews Wilkins 2005161 and Wormald 2001162.

For the antimetabolite MMC: 3 studies do not report details of randomisation method26,123,147. 3 studies do not report details of allocation concealment94,118,147. 3 studies do not report masking of outcome assessment26,118,147. Only 2 studies were placebo controlled26,147. For the antimetabolite 5-FU: 2 studies do not report details of randomisation method39,113. 3 studies do not report details of allocation concealment, masking of outcome assessment and are not placebo controlled39,49,113. One study88 is a placebo controlled double blind design.

Wide confidence intervals making estimate of effect uncertain.

Although there is no statistical heterogeneity observed other differences between studies are noted in type of antimetabolite (MMC or 5-FU) used and dosage, delivery method of 5-FU (intraoperative or postoperative injections), IOP failure criteria, length of follow up, reporting of complications, proportion of patients with closed-angle glaucoma of <50%, mean baseline IOP and whether patients received previous laser treatment. One study39 is exclusively in Afro-Caribbean patients and one study123 is exclusively in patients from the Indian sub-continent.

From: 8, Treatment of chronic open angle glaucoma

Cover of Glaucoma
Glaucoma: Diagnosis and Management of Chronic Open Angle Glaucoma and Ocular Hypertension.
NICE Clinical Guidelines, No. 85.
National Collaborating Centre for Acute Care (UK).
Copyright © 2009, National Collaborating Centre for Acute Care.

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