Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment study (SPR Study): recruitment list evaluation. Study report no. 2
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Accompanying the patient recruitment within the “Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment multicentre trial (SPR)”, all patients with primary rhegmatogenous retinal detachment (RRD) had to be documented in a detailed recruitment list. The main goal of this analysis was to estimate the prevalence of “medium-severe” RRD (SPR Study eligible) as defined by the SPR Study inclusion criteria. In addition, the detailed anatomical situation of medium-severe RRD is investigated.
SPR Study recruitment was evaluated via a standardised questionnaire, which contained a coloured fundus drawing and information regarding possible reasons for exclusion from the SPR Study in each case. A team of three experienced vitreoretinal surgeons evaluated all fundus drawings from a 1-year period. The review led to a decision on SPR Study eligibility on the pure basis of anatomical assessment. The main outcome measures were assessment of feasible inclusion into the SPR Study by the evaluation team based on the fundus drawing and anatomical details.
A total of 1,115 patients with RRD from 13 European centres were prospectively enrolled in the year 2000. The quality of the drawings sufficed for assessment in 1,107 cases (99.3%). Three hundred and twelve fundus drawings (28.2%) met the anatomic inclusion criteria of the SPR Study. RRD of medium severity is characterised by an average number of 2.6 (SD 2.4) retinal breaks, 5.8 (SD 2.8) clock hours of detached retina, unclear hole situation in 15.1% of cases (n=47), attached macula in 42.9% (n=134), bullous detachment in 15.1% (n=47) and vitreous haemorrhage/opacity in 7.7% (n=24).
In the recruitment lists of the SPR Study of the year 2000, RRD of medium severity was present in nearly one third of the patients with primary RRD. These findings emphasise the clinical relevance of the SPR Study.
KeywordsRetinal detachment Scleral buckling Pars plana vitrectomy Recruitment SPR
The SPR Study was supported by - Deutsche Forschungsgesellschaft (DFG Number Fo 165/ 2–1 – 2–4; Le 842/ 3–1/2; Hi 541/ 2–1/2) - Stifterverband für die Deutsche Wissenschaft (Friedrich Spicker-Stiftung) Number S 050– 10.003/004–Retinologische Gesellschaft.
Principal clinical investigator: M.H. Foerster
Principal investigator medical statistics: D.-H. Hilgers
Study co-ordinator: C. Weiss
Surgeons and coworkers (alphabetical order): K.-U. Bartz-Schmidt, Binder, S. Bopp, N. Bornfeld, C. Dahlke, F. Faude, M.H. Foerster, W. Friedrichs, V.P. Gabel, J. Garweg, A. Gaudric, W. Göbel, S. Grisanti, C. Groenewald, L.L. Hansen, L. Hattenbach, K. Hille, H. Hoerauf, F. Holz, P. Janknecht, J. Jonas, U. Kellner, B. Kirchhof, F. Koch, F. Körner, H. Laqua, Y. LeMer, M. Loew, A. Lommatzsch, K. Lucke, P. Meier, E. Messmer, U. Mester, M. Partsch, D. Pauleikhoff, I. Pearce, J. Roider, H. Schilling, W. Schrader, N. Schrage, U. Stolba, P. Walter, B. Wiechens, S. Wolf, D. Wong.
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