A randomized clinical trial of isolated ambulatory phlebectomy versus saphenous thermal ablation with concomitant phlebectomy (SAPTAP Trial).

BACKGROUND: Current treatment of patients with saphenous trunk and tributary incompetence consists of truncal ablation with concomitant, delayed or no treatment of the tributary. However, reflux of the saphenous trunk may be reversible after treatment of the incompetent tributary. The aim of this study was to determine whether single ambulatory phlebectomy with or without delayed endovenous truncal ablation (SAP) is non-inferior to thermal endovenous ablation with concomitant phlebectomy (TAP), and whether SAP is a cost-effective alternative to TAP. METHODS: A multicentre, non-inferiority RCT was conducted in patients with an incompetent great saphenous vein or anterior accessory saphenous vein with one or more incompetent tributaries. Participants were randomized to receive SAP or TAP. After 9 months, additional truncal treatment was considered for SAP patients with remaining symptoms. The primary outcome was VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms (VEINES-QOL/Sym score) after 12 months. Secondary outcomes were, among others, cost-effectiveness, perceived improvement of symptoms, and anatomical success. RESULTS: Some 464 patients received the allocated treatment (SAP 227, TAP 237). VEINES-QOL scores were 52.7 (95 per cent c.i. 51.9 to 53.9) for SAP and 53.8 (53.3 to 55.1) for TAP; VEINES-Sym scores were 53.5 (52.6 to 54.4) and 54.2 (54.0 to 55.6) respectively. Fifty-eight patients (25.6 per cent) in the SAP group received additional truncal ablation. Treatment with SAP was less costly than treatment with TAP. CONCLUSION: One year after treatment, participants who underwent SAP had non-inferior health-related quality of life compared with those who had TAP. Treatment with SAP was a cost-effective alternative to TAP at 12 months. REGISTRATION NUMBER: NTR 4821 (www.trialregister.nl).

Topical corticosteroids in atopic dermatitis and the risk of glaucoma and cataracts.

INTRODUCTION: There is concern about the development of glaucoma and cataracts associated with topical corticosteroid use in patients with atopic dermatitis (AD). OBJECTIVE: We evaluated glaucoma and cataract development in patients with AD to determine whether they are associated with the cumulative dose of topical steroids and the use of topical corticosteroids on the eyelids and periorbital region. METHODS: In all, 88 patients with AD were recruited from the University Medical Centre Utrecht. Patients were interviewed and completed a questionnaire assessing different factors such as AD involvement of eyelids and periorbital skin. The use of corticosteroids in previous years was obtained from pharmacy records. A complete ophthalmologic examination was performed for the presence of glaucoma and cataracts. RESULTS: Of the 88 patients (41 men and 47 women), with an average age of 37.2 ± 14.3 years (mean ± SD), one patient had transient ocular hypertension and one patient had optic disc cupping without any glaucomatous defects in his visual field. Seven patients were given the diagnosis of cataracts (one AD-related, two corticosteroid-induced, and 4 age-related). Both patients with corticosteroid-induced cataracts had also used systemic corticosteroids. In all, 37 of the 88 patients had used topical corticosteroids (class III and IV) on the eyelids and periorbital region, with an average frequency of 3.9 days per week and 6.4 months per year for 4.8 years. LIMITATIONS: Small sample size, objectiveness of patient recall about the use of topical corticosteroids on the eyelids/periorbital region, overestimation of topical corticosteroid use from pharmacy records, and lack of information on lifetime corticosteroid use were limitations. CONCLUSIONS: In this retrospective study glaucoma was not seen; two patients with AD had corticosteroid-induced cataracts, which were probably caused by the use of systemic corticosteroids. The application of topical corticosteroids to the eyelids and periorbital region, even over longer periods of time, was not related to the development of glaucoma or cataracts in this study population.