Retinal Detachment Clinical Trial
To compare, through a randomized, multicenter surgical trial, the postoperative tamponade
effectiveness of intraocular silicone oil with that of an intraocular long-acting gas
(initially sulfur hexafluoride [SF 6 ], later perfluoropropane [C 3 F 8 ]) for the
management of retinal detachment complicated by proliferative vitreoretinopathy (PVR), using
vitrectomy and associated techniques.
To evaluate the ocular complications that result from the use of silicone oil and gas.
The treatment of retinal detachment complicated by PVR remains controversial. Although some
cases are managed successfully by pars plana vitrectomy and with temporary tamponade
provided by intraocular gas, others eventually redetach with this technique. Preliminary
reports indicate that prolonged tamponade with liquid silicone results in improved
anatomical success, but the eventual visual outcome may be prejudiced by silicone-related
complications, particularly glaucoma and keratopathy. The addition of hydraulic reattachment
by simultaneous fluid/gas exchange to vitrectomy surgery has proved to be an important
development. Although complications are few with these procedures, subsequent redetachment
is frequent.
The Silicone Study was a randomized trial to investigate the relative merits of silicone oil
or gas as tamponade modalities. All study patients underwent vitrectomy and were randomized
intraoperatively either to silicone oil or to gas. Two groups of eyes were entered into the
study: eyes that had not had a prior vitrectomy (Group 1) and those that had undergone
previous vitrectomy outside the study (Group 2).
A critical element in the study was a standardized surgical procedure for PVR. This surgical
procedure, intended to relieve retinal traction with vitrectomy techniques, was followed by
assessment of the relief provided by an intraocular air tamponade. The eye was randomized to
silicone oil or gas only after completion of the entire surgical procedure to eliminate
investigator bias that might develop through knowledge of the treatment modality. Patients
were examined 5 to 14 days following the randomization and again at 1, 3, 6, 12, 18, 24, and
36 months after that date. Repeated surgery was permitted for either treatment modality. The
Fundus Photograph Reading Center staff processed and analyzed photographs taken at all the
clinics, graded the preoperative severity of PVR on the basis of baseline visit photographs,
and confirmed the macular status at followup visits.
End points of the study were visual acuity of 5/200 or greater and macular reattachment for
6 months following the final surgical procedure. The successful outcomes and complication
rates of the two modalities were compared.
;
Allocation: Randomized, Primary Purpose: Treatment
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