Trials / Completed
CompletedNCT01255306
The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- University Hospital Sestre Milosrdnice · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Optical 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 |
| DRUG | Local 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. |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2011-11-01
- Completion
- 2011-12-01
- First posted
- 2010-12-07
- Last updated
- 2012-03-23
- Results posted
- 2012-01-24
Locations
1 site across 1 country: Croatia
Source: ClinicalTrials.gov record NCT01255306. Inclusion in this directory is not an endorsement.