Corneal cross-linking is widely used to treat keratoconus. However, to date, only limited data from randomized trials support its efficacy. The efficacy and safety of corneal cross-linking for halting progression of keratoconus were investigated in a prospective, randomized, blinded, placebo controlled, multicentre trial. Twenty-nine keratoconus patients were randomized in three trial centres. The mean age at inclusion was 28 years. Longitudinal changes in corneal refraction were assessed by linear regression. The best corrected visual acuity, surface defects and corneal inflammation were also assessed. These data were analysed with a multifactorial linear regression model. A total of 15 eyes were randomized to the treatment and 14 to the control group. Follow-up averaged 1098 days. Corneal refractive power decreased on average (+/−standard deviation) by 0.35 +/− 0.58 dioptres/year in the treatment group. The controls showed an increase of 0.11 +/− 0.61 dioptres/year. This difference was statistically significant (p = 0.02). Our data suggest that corneal cross-linking is an effective treatment for some patients to halt the progression of keratoconus. However, some of the treated patients still progressed, whereas some untreated controls improved. Therefore, further investigations are necessary to decide which patients require treatment and which do not. NCT00626717 , Date of registration: February 20, 2008.
To evaluate the performance and safety of minimally invasive glaucoma surgery with a supraciliary drainage device (MINIject; iSTAR Medical, Wavre, Belgium) in primary open-angle glaucoma (POAG) as a stand-alone procedure. Meta-analysis. At 11 sites in Colombia, France, Germany, India, Panama, and Spain, 82 patients were treated in 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III). Data were pooled in a meta-analysis of up to 2 years of follow-up postimplantation. The main outcome measures were mean relative and absolute reduction in diurnal intraocular pressure (IOP) compared to baseline. Secondary outcomes included patients with IOP ≤18 mmHg, patients with IOP reduction ≥20%, number of IOP-lowering medications, adverse events, and endothelial cell density loss. At the 2-year follow-up (n = 66), mean IOP was reduced from 23.8 ± 3.3 mmHg at baseline to 14.4 ± 4.5 mmHg (-39.3%; P < 0.0001). An IOP reduction of ≥20% was achieved in 89.4% of patients, with 84.8% having an IOP ≤18 mmHg. IOP-lowering medications were reduced from a mean of 2.4 ± 1.1 to 1.4 ± 1.4 (P < 0.0001), with 37.9% of patients being medication-free at 2 years. Mean endothelial cell density loss at 2 years was 6.2 ± 9.1% compared to baseline and no patient had a loss >30%. This meta-analysis demonstrates the favorable safety and efficacy profile of a supraciliary device implanted in a stand-alone, ab-interno procedure in patients with mild-to-moderate POAG. The data demonstrate that MINIject is a safe and effective, bleb-free treatment option for patients requiring low target IOP up to 2 years.
This retrospective, single-center study evaluates the safety and efficacy of PreserfloTM MicroShunt (MicroShunt) implantations compared to trabeculectomies (TETs) in patients diagnosed with pseudoexfoliation glaucoma (PEXG). A total of 31 eyes from 28 patients received a MicroShunt implantation, and 29 eyes from 26 patients received a TET. Surgical success was defined as an intraocular pressure (IOP) between 5 mmHg and 17 mmHg at the end of the follow-up period, no need for surgical revisions or secondary glaucoma surgery, and no loss of light perception. In the MicroShunt group, the mean IOP dropped from 20.8 ± 5.9 mmHg at baseline to 12.4 ± 2.8 mmHg (p < 0.0001) after one year. In the TET group, the mean IOP dropped from 22.3 ± 6.5 mmHg to 11.1 ± 3.7 mmHg (p < 0.0001) after 12 months. In both of the groups, the mean number of medications was reduced significantly (MicroShunt from 2.7 ± 1.2 to 0.2 ± 0.7; p < 0.0001 vs. TET from 2.9 ± 1.2 to 0.3 ± 0.9; p < 0.0001). Considering the success rates, 83.9% of the MicroShunt eyes achieved complete success, and 90.3% qualified for success at the end of the follow-up period. In the TET group, the rates were 82.8% and 93.1%, respectively. The postoperative complications were comparable between both groups. In conclusion, the MicroShunt implantation demonstrated non-inferiority regarding its efficacy and safety profile compared to TET in PEXG at a follow-up of one year.
14 August 2019 in Klinische Monatsblätter für Augenheilkunde
Zusammenfassung: Das Pseudoexfoliationssyndrom (PEX-Syndrom) ist eine häufige, mit dem Alter zunehmende und weltweit auftretende Erkrankung. Charakteristisch ist die Produktion und Ablagerung von extrazellulärem, fibrillärem Material im Bereich der vorderen Augenkammer. Mit einem breiten Spektrum potenzieller Komplikationen ist die Relevanz sowohl für die konservative als auch die operative Ophthalmologie groß.