Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000140
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-09-23
Brief Title:
The Silicone Study
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
To evaluate the ocular complications that result from the use of silicone oil and gas
Detailed Description:
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 fluidgas 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 5200 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
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 5200 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None