The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy

Rhegmatogenous Retinal Detachment Clinical Trial

Official title:

The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255306
• Other study ID #: KBSM-30-1/10
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: March 22, 2012
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: University Hospital "Sestre milosrdnice"
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma Due to Silicon Oil
• Retinal Detachment
• Rhegmatogenous Retinal Detachment
• Toxic Effect of Silicone

Intervention

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: On 7th postoperative day On 30th postoperative day On 90th postoperative day 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.

Locations

Country	Name	City	State
Croatia	University Department of Ophthalmology, University Hospital "Sestre milosrdnice", Vinogradska 29	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital "Sestre milosrdnice"

Country where clinical trial is conducted

Croatia, 

References & Publications (9)

Al-Jazzaf AM, Netland PA, Charles S. Incidence and management of elevated intraocular pressure after silicone oil injection. J Glaucoma. 2005 Feb;14(1):40-6. — View Citation

Honavar SG, Goyal M, Majji AB, Sen PK, Naduvilath T, Dandona L. Glaucoma after pars plana vitrectomy and silicone oil injection for complicated retinal detachments. Ophthalmology. 1999 Jan;106(1):169-76; discussion 177. — View Citation

Inoue M, Iriyama A, Kadonosono K, Tamaki Y, Yanagi Y. Effects of perfluorocarbon liquids and silicone oil on human retinal pigment epithelial cells and retinal ganglion cells. Retina. 2009 May;29(5):677-81. doi: 10.1097/IAE.0b013e318196fca1. — View Citation

Kee C, Cho C. Evaluation of retinal nerve fiber layer thickness in the area of apparently normal hemifield in glaucomatous eyes with optical coherence tomography. J Glaucoma. 2003 Jun;12(3):250-4. — View Citation

Leung CK, Cheung CY, Weinreb RN, Qiu Q, Liu S, Li H, Xu G, Fan N, Huang L, Pang CP, Lam DS. Retinal nerve fiber layer imaging with spectral-domain optical coherence tomography: a variability and diagnostic performance study. Ophthalmology. 2009 Jul;116(7):1257-63, 1263.e1-2. doi: 10.1016/j.ophtha.2009.04.013. Epub 2009 May 22. — View Citation

Mastropasqua L, Carpineto P, Ciancaglini M, Falconio G, Harris A. Reproducibility of nerve fiber layer thickness measurements using optical coherence tomography in silicone oil-filled eyes. Ophthalmologica. 2001 Mar-Apr;215(2):91-6. — View Citation

Shah NN, Bowd C, Medeiros FA, Weinreb RN, Sample PA, Hoffmann EM, Zangwill LM. Combining structural and functional testing for detection of glaucoma. Ophthalmology. 2006 Sep;113(9):1593-602. — View Citation

Wollstein G, Schuman JS, Price LL, Aydin A, Beaton SA, Stark PC, Fujimoto JG, Ishikawa H. Optical coherence tomography (OCT) macular and peripapillary retinal nerve fiber layer measurements and automated visual fields. Am J Ophthalmol. 2004 Aug;138(2):218-25. — View Citation

Yalvac IS, Altunsoy M, Cansever S, Satana B, Eksioglu U, Duman S. The correlation between visual field defects and focal nerve fiber layer thickness measured with optical coherence tomography in the evaluation of glaucoma. J Glaucoma. 2009 Jan;18(1):53-61. doi: 10.1097/IJG.0b013e318179f751. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	6 months	Yes
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.	6 months	Yes