Oral prolonged-release ketamine in treatment-resistant depression - A double-blind randomized placebo-controlled multicentre trial of KET01, a novel ketamine formulation - Clinical and safety results.

INTRODUCTION: We investigated the antidepressant effects of a novel oral prolonged-release formulation of racemic ketamine (KET01) in patients suffering from treatment-resistant depression (TRD) as add-on therapy. MATERIAL AND METHODS: Patients were randomized to an additional 160 mg/day or 240 mg/day KET01 or placebo for 14 days. The primary endpoint was change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline to day 15. For treatment group comparisons, we used ANOVA with pairwise least squares mean difference tests in a mixed model repeated measures analysis. RESULTS: Twenty-seven patients completed the double-blind protocol before trial premature termination due to poor recruitment during the COVID-19 pandemic. Mean (SD) MADRS scores on day 15 were 23 (10.32) in placebo, 25 (8.28) with 160 mg/day and 17 (10.32) with 240 mg/day KET01. MADRS change was numerically larger but statistically non-significant in the 240 mg/day KET01 group vs placebo on day 7 (-5.67; p = 00.106) and day 15 was (difference: 4.99; p = 00.15). In exploratory analysis, baseline leukocyte count correlated with response to KET01 (p = 00.01). Distribution of adverse event rates were comparable between the treatment arms. Safety analysis did not identify increased risk of suicidality, dissociation, hear rate, systolic and diastolic blood pressure associated with trial treatment. DISCUSSION: Our results suggest that adjunctive oral administration of prolonged-release ketamine at a dose of 240 mg/day shows a positive, although statistically non-significant, trend towards antidepressant efficacy, however, the benefit could not be confirmed due to premature trial termination. Given its ease of use and low side effects, further trials are warranted to investigate this route of ketamine administration as a promising potential treatment of TRD.

Stray light in photorefractive keratectomy for myopia.

We performed a study to evaluate the influence on visual function of intraocular straylight after photorefractive keratectomy (PRK). We present 4 eyes of 4 myopic individuals, who had contacted our clinic for keratorefractive surgical treatment. PRK's were performed with a Summit laser, using a 5 mm ablation zone. The straylight meter was used to measure the amount of intraocular scattered light, the physical cause of glare complaints, before and after PRK. This apparatus uses the direct compensation method to assess the amount of intraocular light scatter. The results showed a significant increase in straylight values, in the tested eyes, during the first two weeks after PRK. After the initial rise, straylight values returned to preoperative levels, except for two eyes that clearly developed a haze higher than grade two. Instead of returning to baseline levels, straylight values remained significantly higher in these eyes.

Differentiated treatment of secondary cataract following extracapsular cataract operation.

161 eyes with Nd:YAG laser posterior capsulotomy after in the bag IOL implantation 1-3 years before, were actively followed over a period of 24 +/- 6 months. No CME nor retinal detachment nor induced glaucoma was found. Therefore a YAG capsulotomy in eyes with completely in the bag implanted IOL seems to assure the same level of security than capsular polishing in eyes with sulcus implanted lenses.

Phacoemulsification of the subluxated or atopic lens.

In cases of an ectopic lens (e.g. Marfan Syndrome) with elongated zonular fibers, the lens can be partially emulsified. This can be done in such a way that it leaves behind a diaphragm consisting of zonular fibers and posterior capsule which is strong enough to support a posterior chamber lens. In cases of traumatically subluxated lenses intercapsular phacoemulsification can be done. The zonular dialysis can be fixed by suturing the capsule directly into the sulcus. The PCL can then be implanted either into the capsular bag or into the sulcus. Suture fixation of a posterior capsule is also possible as a reconstructive measure in previously extracapsular operated eyes.

Stray light in photorefractive keratectomy for myopia.

We are performing a prospective study, with the "Straylight meter", to evaluate the effects of PRK, on intraocular straylight. Results show a significant increase in straylight values, during the first two weeks after treatment. There is no correlation between the amount of haze, and intraocular light scatter.