N/A
Completed N=59
The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
Rhegmatogenous retinal detachment · Toxic Effect of Silicone · Glaucoma Due to Silicon Oil
Source: ClinicalTrials.gov NCT01255306 ↗
Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography — 96.23; 87.07; 96.09; 87.93 micrometer
Summary
The aim of the study is to evaluate the influence of silicone oil on thickness of the retinal nerve fiber layer by using optical coherence tomography (OCT) in patients following pars plana vitrectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography |
96.23; 87.07; 96.09; 87.93; 97.56; 87.37 | — |
| SECONDARY Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade |
96.08; 96.34; 87.07; 93.76; 97.91; 87.93 | — |
Eligibility Criteria
Inclusion Criteria
- patients with rhegmatogenous retinal detachment
Exclusion Criteria
- preexistent glaucoma
- previous retinal surgery
- placement of scleral buckle during surgery
- patients with more than 1/2 of emulsified silicone oil in anterior chamber postoperatively
- patients who develop silicone oil keratopathy postoperatively
- patients who develop silicone oil cataract which blocks visualization of posterior segment
Data sourced from ClinicalTrials.gov (NCT01255306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.