Universität zu Köln

Scholz, Paula ORCID: 0000-0002-1730-0566, Muether, Philipp S., Schiller, Petra, Felsch, Moritz and Fauser, Sascha (2018). A Randomized Controlled Clinical Trial Comparing 20 Gauge and 23 Gauge Vitrectomy for Patients with Macular Hole or Macular Pucker. Adv. Ther., 35 (12). S. 2152 - 2167. NEW YORK: SPRINGER. ISSN 1865-8652

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Abstract

IntroductionTo compare the transconjunctival sutureless 23 gauge (G) pars plana vitrectomy (PPV) with 20 G PPV regarding inflammation, safety, visual outcome and patient comfort.MethodsWe 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 3weeks after surgery compared with baseline. Secondary outcome measures were flare values 2days and 26weeks after surgery, subjective discomforts measured with a visual analog scale, best-corrected visual acuity, duration of surgery, intraocular pressure (IOP) and adverse events.ResultsThere was no significant difference in change of flare 3weeks 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 3weeks (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 6months. The duration of surgery was shorter in the 23G group (p<0.001). Patient comfort 3weeks 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.ConclusionThe primary aim, showing the superiority of the 23G group regarding the change of flare value from baseline to 3weeks 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 NumberClinicalTrials.gov NCT01969929.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Scholz, Paula UNSPECIFIED orcid.org/0000-0002-1730-0566 UNSPECIFIED Muether, Philipp S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schiller, Petra UNSPECIFIED UNSPECIFIED UNSPECIFIED Felsch, Moritz UNSPECIFIED UNSPECIFIED UNSPECIFIED Fauser, Sascha UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-163413
DOI:	10.1007/s12325-018-0826-6
Journal or Publication Title:	Adv. Ther.
Volume:	35
Number:	12
Page Range:	S. 2152 - 2167
Date:	2018
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1865-8652
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language NUCLEAR SCLEROTIC CATARACT; SUTURELESS VITRECTOMY; 20-GAUGE VITRECTOMY; 23-GAUGE; 25-GAUGE Multiple languages Medicine, Research & Experimental; Pharmacology & Pharmacy Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/16341