Comparison of Efficacy and Safety of Bleb Needle Revision With and Without 5-Fluorouracil for Failing Trabeculectomy Bleb

Abstract

Précis: Bleb needle revision with and without 5-FU showed similar success rates over the course of a long-term follow-up. A greater total number of needle revisions was identified as a risk factor for procedural failure. Purpose: The purpose of the study was to investigate the efficacy and safety of bleb needle revision with adjunctive 5-fluorouracil (5-FU) subconjunctival injection in large-scaled patients with failing trabeculectomy bleb. Materials and Methods: A retrospective chart review was performed on a total of 113 eyes of 106 subjects who had undergone trabeculectomy followed by needle revision and been followed up for at least 6 months. The subjects were divided into 2 groups according to whether they had also undergone concurrent adjunctive 5-FU subconjunctival injection. Two definitions of failure were derived irrespective of IOP-lowering medication use and were assessed at each follow-up visit: (1) IOP>21 mm Hg or >85% of preoperative IOP or reoperation for glaucoma, (2) IOP>18 mm Hg or >80% of preoperative IOP or reoperation for glaucoma. Results: A total of 78 eyes of 73 subjects underwent the simple needle revision procedure and 35 eyes of 33 subjects underwent needle revision with subconjunctival 5-FU injection. There was no significant adverse event for either group and no significant IOP difference in any of the observational periods between them (P=0.867). There was also no statistically significant difference in the total number of IOP-lowering medications between the groups (P=0.199). The success rate at 24 months after the first needle revision was 45.6% (95% CI: 33.7, 56.7) in simple revision group and 44.6% (95% CI: 27.7, 60.2) in 5-FU needle revision group by failure 1, 36.3% (95% CI: 25.4, 47.2) and 32.9% (95% CI: 18.0, 48.6) by failure 2, respectively. A greater total number of needle revisions was the significant risk factors for needle revision failure (HR=2.25 and P=0.001 according to failure 2). Conclusions: Bleb needle revision with 5-FU subconjunctival injection is a safe procedure for failing trabeculectomy bleb. Bleb needle revision with and without 5-FU were equally likely to succeed.

Needling after trabeculectomy ‐ does augmentation by anti‐metabolites provide better outcomes and is Mitomycin C better than 5‐Fluoruracil? A systematic review with network meta‐analyses

“…Four included studies compared MMC to 5‐FU (Fagerli et al, 2003; Anand & Khan, 2009; Palejwala et al, 2010; Liu et al, 2016), two studies compared MMC to no anti‐metabolite (Fagerli et al, 2003; Ghoneim & Abd El Hameed, 2011) and 5‐FU was compared to no anti‐metabolite in two studies (Fagerli et al, 2003; Kim et al, 2019). Four (Anand & Khan, 2009; Palejwala et al, 2010; Liu et al, 2016; Kim et al, 2019) of the studies included patients with primary open‐angle glaucoma, primary angle‐closure glaucoma and secondary glaucomas (exfoliative (pseudo‐exfoliative) glaucoma, pigmentary glaucoma, lens‐induced open‐angle glaucoma, glaucoma associated with intraocular haemorrhage, uveitic glaucoma and open‐angle glaucoma due to ocular trauma); one study (Ghoneim & Abd El Hameed, 2011) included patients with primary open‐angle glaucoma; and one study (Fagerli et al, 2003) included patients with primary open‐angle glaucoma and secondary glaucomas. An overview of the included studies is provided in Table 1.…”

“…The included studies comprised one randomized controlled trial (Liu et al 2016) (level 1b) and five non‐randomized comparative trials (Fagerli et al, 2003; Anand & Khan, 2009; Palejwala et al, 2010; Ghoneim & Abd El Hameed, 2011; Kim et al, 2019) (level 2b). The included studies differed on characteristics such as study design (i.e.…”

“…All six studies reported measures of comparative efficacy on IOP at least 12 months after needling augmented by either MMC (five studies) (Fagerli et al, 2003; Aanand & Khan, 2009; Palejwala et al 2010; Ghoneim & Abd El Hameed, 2011; Liu et al, 2016), 5‐FU (five studies) (Fagerli et al, 2003; Aanand & Khan, 2009; Palejwala et al 2010; Liu et al, 2016; Kim et al 2019) or no anti‐metabolites (three studies) (Fagerli et al, 2003; Ghoneim & Abd El Hameed, 2011; Kim et al 2019). These studies contributed with eligible data for comparison of efficacy on the IOP for 455 eyes.…”

“…Four included studies compared MMC to 5-FU (Fagerli et al, 2003;Anand & Khan, 2009;Palejwala et al, 2010;Liu et al, 2016), two studies compared MMC to no anti-metabolite (Fagerli et al, 2003;Ghoneim & Abd El Hameed, 2011) and 5-FU was compared to no anti-metabolite in two studies (Fagerli et al, 2003;Kim et al, 2019). Four (Anand & Khan, 2009;Palejwala et al, 2010;Liu et al, 2016;Kim et al, 2019) and one study (Fagerli et al, 2003) included patients with primary openangle glaucoma and secondary glaucomas. An overview of the included studies is provided in Table 1.…”

“…Two of these did not provide comparative data (Fagerli et al, 2003;Palejwala et al 2010). Remaining studies contributed with comparative data on complication rates for 209 eyes (Anand & Khan, 2009;Ghoneim & Abd El Hameed, 2011;Liu et al, 2016;Kim et al, 2019). Anand & Khan (2009) reported complications at different stages of time after needling: early (bleeding into anterior chamber during needling, shallow anterior chamber immediately after needling, hyphema, shallow anterior chamber, choroidal detachment, leak through entry site and delayed suprachoroidal haemorrhage) and late (persistent choroidal effusions, late bleb leaks, blebitis, aqueous misdirection, unexplained loss of vision, bandshaped keratopathy and corneal decompensation).…”