Glaucoma Due to Silicon Oil, Rhegmatogenous Retinal Detachment, Toxic Effect of Silicone
Conditions
Keywords
Rhegmatogenous retinal detachment, Pars plana vitrectomy, Silicone oil, Retinal nerve fibre layer
Brief 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.
Detailed description
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. The study will include 60 patients with a temporary silicone oil tamponade who will be surgically treated with pars plana vitrectomy for rhegmatogenous retinal detachment and proliferative vitreoretinopathy. All subjects will be subdued to complete ophthalmologic examinations, measurements of the retinal nerve fiber layer thickness by an OCT examination, tests of the visual field with the use of an Octopus computed perimeter (automated static perimetry) and FDT-perimetry - both prior to the surgery, and on control visits for check-up during the postoperative period. All results provided by postoperative examinations will be compared with one another. The study is expected to provide data on the effect of the silicone oil on thickness of the retinal nerve fiber layer. It is also planned to show possibilities and advantages of OCT as a method of choice in the follow-up of patients with intraocular silicone oil tamponade.
Interventions
OTHEROptical coherence tomography
Optical coherence tomography will be performed in all study patients following pars plans vitrectomy and silicone oil tamponade. A fellow eye of each patient will serve as a control. Each patient enrolled in a study will receive 4 measurements: 1. On 7th postoperative day 2. On 30th postoperative day 3. On 90th postoperative day 4. On 180th postoperative day
DRUGLocal medical treatment of raised intraocular pressure
In patients with raised intraocular pressure following medications will be employed in order to control the intraocular pressure: Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution; b.i.d.) Ganfort (Bimatoprost, timolol maleate ophthalmic solution; once daily) Alphagan (Brimonidine ophthalmic solution; b.i.d.) In patients with intraocular pressure less than 27 mmHg Alphagan will be prescribed. In patients with intraocular pressure greater than 27 mmHg either Cosopt, or Ganfort will be prescribed under the discretion of treating physician. If intraocular pressure in patients treated with either Cosopt or Ganfort does not drop under 21 mmHg, Alphagan will be added.
Sponsors
University Hospital Sestre Milosrdnice
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | 6 months | Retinal nerve fiber layer thickness change measured by optical coherence tomography might be an additional parameter that could provide new insights into clinical decision making in patients with silicone oil tamponade. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | 6 months | To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade. |
Countries
Croatia
Participant flow
Recruitment details
Patients with a diagnosis of retinal detachment who fulfilled enrolment criteria were included in the study. All patient were enrolled through University Department of Ophthalmology, University Hospital Sestre milosrdnice. The recruitment started in April 2010 and the last patient was enrolled in June 2011.
Pre-assignment details
We excluded one patient who developed severe inflammatory reaction 5 days following pars plana vitrectomy and silicone oile tamponade from the study.
Participants by arm
| Arm | Count |
|---|---|
| NO IOP Patients without raised IOP | 26 |
| RAISED IOP Patients with raised IOP | 33 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 1 |
Baseline characteristics
| Characteristic | RAISED IOP | NO IOP | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 15 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 11 Participants | 36 Participants |
| Age Continuous | 58.21 years STANDARD_DEVIATION 12.26 | 63.80 years STANDARD_DEVIATION 12.97 | 60.67 years STANDARD_DEVIATION 12.77 |
| Region of Enrollment Croatia | 33 participants | 26 participants | 59 participants |
| Sex: Female, Male Female | 11 Participants | 16 Participants | 27 Participants |
| Sex: Female, Male Male | 22 Participants | 10 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 |
Outcome results
Primary
Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography
Retinal nerve fiber layer thickness change measured by optical coherence tomography might be an additional parameter that could provide new insights into clinical decision making in patients with silicone oil tamponade.
Time frame: 6 months
Population: We included all patients that have completed necessary follow up visits and have had optical coherence tomography measurements at all visits in the final analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STUDY EYES | Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | RNFL thickness at 7th postop. day | 96.23 micrometer | Standard Deviation 16.39 |
| STUDY EYES | Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | RNFL thickness at 30th postop. day | 96.09 micrometer | Standard Deviation 21.59 |
| STUDY EYES | Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | RNFL thickness at 90th postop. day | 97.56 micrometer | Standard Deviation 23.72 |
| STUDY EYES | Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | RNFL thickness at 180th postop. day | 100.40 micrometer | Standard Deviation 23.35 |
| CONTROL EYES | Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | RNFL thickness at 180th postop. day | 88.93 micrometer | Standard Deviation 11.67 |
| CONTROL EYES | Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | RNFL thickness at 7th postop. day | 87.07 micrometer | Standard Deviation 10.79 |
| CONTROL EYES | Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | RNFL thickness at 90th postop. day | 87.37 micrometer | Standard Deviation 11.51 |
| CONTROL EYES | Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | RNFL thickness at 30th postop. day | 87.93 micrometer | Standard Deviation 11.14 |
Secondary
Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade
To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade.
Time frame: 6 months
Population: We included all patients who completed follow up visits and who had valid OCT measurements as defined per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STUDY EYES | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 7th postop. day | 96.08 micrometer | Standard Deviation 15.18 |
| STUDY EYES | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 30th postop. day | 93.76 micrometer | Standard Deviation 17.65 |
| STUDY EYES | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 90th postop. day | 96.44 micrometer | Standard Deviation 23.08 |
| STUDY EYES | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 180th postop. day | 101.76 micrometer | Standard Deviation 23 |
| CONTROL EYES | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 180th postop. day | 99.34 micrometer | Standard Deviation 23.93 |
| CONTROL EYES | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 7th postop. day | 96.34 micrometer | Standard Deviation 17.51 |
| CONTROL EYES | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 90th postop. day | 98.44 micrometer | Standard Deviation 24.53 |
| CONTROL EYES | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 30th postop. day | 97.91 micrometer | Standard Deviation 24.35 |
| CONTROL | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 180th postop. day | 88.93 micrometer | Standard Deviation 11.67 |
| CONTROL | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 30th postop. day | 87.93 micrometer | Standard Deviation 11.14 |
| CONTROL | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 90th postop. day | 87.37 micrometer | Standard Deviation 11.51 |
| CONTROL | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | RNFL thickness at 7th postop. day | 87.07 micrometer | Standard Deviation 10.79 |