The documentation of safety and performance of silicone oil as temporary tamponade in retinal surgery.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intraocular pressure, macula attached.
Secondary outcome
Preoperatively:
Demographic characteristics: gender, age, ethnicity.
Preoperatively, at postop day 1 and 14 (± 3), and at week 26 (± 2):
Proportion of patients with IOP within 5-25 mm Hg.
Proportion of patients with retina attached.
Proportion of patients with macula attached.
Preoperatively, at week 6 (± 1), 26 (± 2) and 52 (± 4):
Visual acuity.
Peroperatively:
Diagnostic details, surgical procedure.
Intaoperative adverse events.
At any (other) postoperative visit:
Proportion of patients with IOP within 5-25 mm Hg.
Proportion of patients with retina attached.
Proportion of patients with macula attached.
Keratopathy.
Silicone oil emulsification.
Silicone oil in anterior chamber.
Date of silicone oil removal.
Additional surgery.
Glaucoma medication.
Intraocular inflammation.
Optic neuropathy or abnormalities of the retinal nerve fibre layer.
Cataract classification (LOCS).
Other postoperative adverse events/complications.
Background summary
Standard treatment for patients with complex retinal detachment (RD) involves
pars plana vitrectomy in combination with silicone oil tamponade. With this
study, we will be able to reliably evaluate the clinical outcomes of patients
treated for complex RD.
Study objective
The documentation of safety and performance of silicone oil as temporary
tamponade in retinal surgery.
Study design
Prospective observational.
Intervention
Intervention is identical to conventional intervention (sterilization is
different).
Study burden and risks
Treatment of patients does not deviate from standard surgery. Measurements for
the purpose of this study will include standard clinical assessments only.
Except two extra study visits (2 x 1.5 h), participation in this study does not
involve any additional burden. The product to be used in this study, *Silicone
Oil, 1.000-1.500 mPas, 10 ml syringe*, is identical to the product registered
for the European market, with the exception of its sterilization procedure.
This is not anticipated to affect the risk of adverse events.
Scheijdelveweg 2
Zuidland 3214 VN
NL
Scheijdelveweg 2
Zuidland 3214 VN
NL
Listed location countries
Age
Inclusion criteria
rhegmatogenous retinal detachment and giant tear,
rhegmatogenous retinal detachment and PVR,
diabetic tractional detachment with proliferative diabetic retinopathy.
Exclusion criteria
NA.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45732.078.13 |