Table 8-140Trabeculectomy + antimetabolite drug MMC versus antimetabolite drug 5-FU - 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)138,1652RCTSerious limitations (a)No serious inconsistencyNo serious indirectnessSerious imprecision (b)
Additional notes (c)
Complications: Cataract Formation IOP (follow up 12 months)1381RCTSerious limitations (a)No serious inconsistencyNo serious indirectnessSerious imprecision (b)
Additional notes (c)
Complications: Persistent hypotony IOP (follow up 12 months)138,1652RCTSerious limitations (a)No serious inconsistencyNo serious indirectnessSerious imprecision (b)
Additional notes (c)
Complications: Wound leak IOP (follow up 12 months)138,1652RCTSerious limitations (a)No serious inconsistencyNo serious indirectnessSerious imprecision (b)
Additional notes (c)
Complications: Corneal epithelial defects IOP (follow up 12 months)1651RCTSerious limitations (a)No serious inconsistencyNo serious indirectnessSerious imprecision (b)
Additional notes (c)
a

One study138 reports adequate randomisation methods but neither study reports allocation concealment. Masking of outcome assessment is only performed in one study165.

b

Wide confidence intervals make estimate of effect uncertain.

c

Although there no statistical heterogeneity is observed other differences between studies are noted in antimetabolite dosage, delivery method of 5-FU (intraoperative or postoperative injections), IOP failure criteria, length of follow up, reporting of complications and mean baseline IOP. One study138 was exclusively in Afro-Caribbean patients.

From: 8, Treatment of chronic open angle glaucoma

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