A Randomized Controlled Clinical Trial Comparing 20 Gauge and 23 Gauge Vitrectomy for Patients with Macular Hole or Macular Pucker

Paula Scholz, Philipp S Müther, Petra Schiller, Moritz Felsch, Sascha Fauser, Paula Scholz, Philipp S Müther, Petra Schiller, Moritz Felsch, Sascha Fauser

Abstract

Introduction: To compare the transconjunctival sutureless 23 gauge (G) pars plana vitrectomy (PPV) with 20 G PPV regarding inflammation, safety, visual outcome and patient comfort.

Methods: We included 103 patients with symptomatic macular hole or macular pucker, scheduled for vitrectomy in this prospective, randomized, controlled, mono-center clinical trial. Patients were randomized 1:1 to either 20G PPV (n = 51) or 23G PPV (n = 52). All eyes underwent standard 20G or 23G PPV with membrane peeling. Primary outcome measure was change in aqueous humor flare 3 weeks after surgery compared with baseline. Secondary outcome measures were flare values 2 days and 26 weeks after surgery, subjective discomforts measured with a visual analog scale, best-corrected visual acuity, duration of surgery, intraocular pressure (IOP) and adverse events.

Results: There was no significant difference in change of flare 3 weeks after PPV [- 1.7, 95% CI (- 6.3 to 2.9), p = 0.466]. Both groups showed a significant increase in flare 2 days after surgery (20G: p < 0.001, 23G: p = 0.002), but only the 20G group after 3 weeks (p = 0.011). The gain in visual acuity after 3 weeks was higher after 23G PPV (4.2 95% CI (0.4-8.0, p = 0.029), but without a difference after 6 months. The duration of surgery was shorter in the 23G group (p < 0.001). Patient comfort 3 weeks after surgery was greater after 23G PPV (foreign body sensation p = 0.002; itching: p = 0.021). However, the rate of complications did not differ between the groups.

Conclusion: The primary aim, showing the superiority of the 23G group regarding the change of flare value from baseline to 3 weeks after surgery, was not met, but the level of inflammation decreased faster after 23G PPV. Clear advantages of the 23G PPV were a lower risk of postoperative IOP elevation, a shorter surgery time, faster visual recovery and greater patient comfort in the early postoperative phase.

Clinical trial registration number: ClinicalTrials.gov NCT01969929.

Keywords: 20 Gauge; 23 Gauge; Adverse events; Macular hole; Macular pucker; Randomized controlled clinical trial; Vitrectomy.

Figures

Fig. 1
Fig. 1
Flow diagram gives an overview of the randomization process
Fig. 2
Fig. 2
Forest plots for the subgroup analysis regarding the change in flare values from baseline to week 3. 23G vitrectomy is favored in all subgroups. BCVA best corrected visual acuity, flare aqueous flare in photon counts per millisecond; 20G 20 gauge vitrectomy, 23G 23 gauge vitrectomy
Fig. 3
Fig. 3
Forest plots for the subgroup analysis regarding the change in EDTRS letters from baseline to week 3. 23G vitrectomy is favored in all subgroups. BCVA best corrected visual acuity, ETDRS early treatment diabetic retinopathy study, 20G 20 gauge vitrectomy, 23G 23 gauge vitrectomy

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Source: PubMed

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