The SPR-study
Norbert Bornfeld (Essen)
Background: The “Scleral buckling versus primary vitrectomy in the treatment of rhegmatogenous
retinal detachment study” (SPR-Study) was designed to analyze differences in the
functional outcome of patients with rhegmatogenous retinal detachment (RRD) of medium
complexity treated either with scleral buckling surgery (SBS) or primary vitrectomy (PPPV)
Methods: Prospective randomized multicentre clinical trial of two study arms subtrials. The
first subtrial is addressed to pseudophakic/aphakic (p/a. group), the second subtrial is
addressed to phakic patients (ph. group).
Each subtrial is designed as a parallel group trial, where the outcome of the two treatment
arms SBS and PPPV will be compared. Fourty-six surgeons in 25 centres in 5 European countries
participated in the trial. The main endpoint was defined as change in visual acuity (at the
12 months postoperative visit from baseline). Secondary endpoints were primary success without
retina affecting reoperations, number of retina-affecting reoperations, PVR rate, final anatomical success rate and additionally
in the ph. subtrial the number of cataract-surgeries.
Results: Between 1997 and 2003, a total of 681 patients (265 p/a. subtrial, 416 ph. subtrial) were recruited for the study.
The mean changes in visual acuities were in the p/a. subtrial -0.557 (SD 0.783) LogMar (SBS) and -0.646 (SD 0.686) (PPPV),
and in the ph. subtrial -0.7405 (SD 0.670) (SBS) and -0.571 (SD 0.759) (PPV) with no statistically significant difference
between the two operating methods (p/a.:p = 0.2814, ph.: p = 0.1147). Redetachment rates were in the p/a. subtrial 38.4%
(48/125 SBS) and 21.6% (24/111 PPPV) and in the ph. subtrial 26.3% (51/194 SBS) and 27.6% (53/192 PPPV). In the p/a.
subtrial, primary success rates (p=0.0167) and the number of retina-affecting reoperations (p=0.0161) demonstrated an
advantage for PPPV whereas in the ph. subtrial, patients treated with SBS had significantly less cataract operations during
follow-up (p<0.00005). No significant differences were found within the p/a. subtrial for final anatomical success (p =
0.9078) and the rate of PVR Grade B or C (p = 0.1879). In the phakic subtrial, comparison of primary (p = 0.9137) as well
as final anatomical success (p = 0.8634) did not show significant difference, neither did comparison of PVR rates (p =
0.1938) or number of retina-affecting reoperations (p = 0.1269).
Conclusion: No differences between the two operating methods could be seen regarding the main endpoint defined as
change in visual acuity in pseudophakic as well as phakic patients. Based on the analysis of secondary endpoints, PPPV is
recommended in the p/a. group because of the higher anatomical success rate and the fewer number of retina-affecting reoperations.
In the ph. group, SBS is recommended due to the fewer number of secondary cataract surgeries whilst achieving
similar functional and anatomical results compared to PPPV.