Rhegmatogenous Retinal DetachmentNCT01255306

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

An observational study of Rhegmatogenous Retinal Detachment and Toxic Effect of Silicone, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Rhegmatogenous Retinal Detachment, Toxic Effect of Silicone, Glaucoma Due to Silicon Oil
What is being tested?: Optical coherence tomography and Local medical treatment of raised intraocular pressure
How many people: 60 participants
Where: 1 siteCroatia
Study dates: Apr 2010to Dec 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: tertiary care clinic

Who may be able to join

patients with rhegmatogenous retinal detachment

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Croatia1 site

University Department of Ophthalmology, University Hospital "Sestre milosrdnice", Vinogradska 29
Zagreb, 10000

Other trials in Croatia

About this study

Read the detailed description

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: Rhegmatogenous Retinal Detachment, Toxic Effect of Silicone, Glaucoma Due to Silicon Oil
Being tested: Optical coherence tomography, Local medical treatment of raised intraocular pressure
Keywords: Rhegmatogenous retinal detachment, Pars plana vitrectomy, Silicone oil, Retinal nerve fibre layer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Optical coherence tomographyOther
Also called Cirrus HD OCT ( Carl Zeiss Meditec, Dublin, CA )
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
Local medical treatment of raised intraocular pressureDrug
Also called 1. Cosopt, 2. Ganfort, 3. Alphagan
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.

Study groups in NCT01255306
Study group	Role	What they receive
NO IOP		Patients without raised IOP Receives: Other: Optical coherence tomography
RAISED IOP		Patients with raised IOP Receives: Other: Optical coherence tomography; Drug: Local medical treatment of raised intraocular pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (1)

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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Dec 2011

First posted7 Dec 2010 (estimated)
Study startApr 2010
Primary completionNov 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01255306
Sponsor's protocol ID: KBSM-30-1/10
Status last verified: Mar 2012
First submitted: 6 Dec 2010
Last updated: 23 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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. doi: 10.1016/S0161-6420(99)90017-9.
PubMed 9917800
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. doi: 10.1097/01.ijg.0000145811.62095.fa.
PubMed 15650603
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. doi: 10.1159/000050836.
PubMed 11244337
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.
PubMed 19464061
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. doi: 10.1097/00061198-200306000-00012.
PubMed 12782844
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. doi: 10.1016/j.ajo.2004.03.019.
PubMed 15289130
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. doi: 10.1016/j.ophtha.2006.06.004.
PubMed 16949444
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.
PubMed 19142136
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.
PubMed 19174720
Zoric Geber M, Bencic G, Vatavuk Z, Ivekovic R, Friberg TR. Retinal nerve fibre layer thickness measurements after successful retinal detachment repair with silicone oil endotamponade. Br J Ophthalmol. 2015 Jun;99(6):853-8. doi: 10.1136/bjophthalmol-2014-305839. Epub 2014 Dec 15.
PubMed 25510920

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
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Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
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Active, not recruiting
Ocular Hypotony and Refractive Predictability in RRD Surgery
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RecruitingPhase 1/2
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy
Not yet recruitingPhase 1
The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy
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All Rhegmatogenous Retinal Detachment trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
ClinicalTrials.gov ID: NCT01255306
Acronym / sponsor ID: KBSM-30-1/10
Conditions: Rhegmatogenous Retinal Detachment, Toxic Effect of Silicone, Glaucoma Due to Silicon Oil
Keywords: Rhegmatogenous retinal detachment, Pars plana vitrectomy, Silicone oil, Retinal nerve fibre layer
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University Hospital Sestre MilosrdniceUniversity, hospital or other
Study start: Apr 2010
Primary completion: Nov 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 7 Dec 2010 (estimated)
Results: Posted 24 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

All results provided by postoperative examinations will be compared with one another.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
NO IOP	–	Other: Optical coherence tomographyPatients without raised IOP
RAISED IOP	–	Other: Optical coherence tomography, Drug: Local medical treatment of raised intraocular pressurePatients with raised IOP

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: tertiary care clinic

Key inclusion criteria (1 listed)

patients with rhegmatogenous retinal detachment

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Optical coherence tomographyAlso: Cirrus HD OCT ( Carl Zeiss Meditec, Dublin, CA )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	Other	NO IOP, RAISED IOP
Local medical treatment of raised intraocular pressureAlso: 1. Cosopt, 2. Ganfort, 3. AlphaganIn 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.	Drug	RAISED IOP

Primary outcome

Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography
Time frame: 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.

1 secondary outcome

Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade
Time frame: 6 months

Results and safety

Results posted to the registry on 24 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NO IOP	26	25
RAISED IOP	33	32

Primary outcome: Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography

Time frame: 6 months. Mean (Standard Deviation). Unit: micrometer

Measure	STUDY EYES n = 57	CONTROL EYES n = 57
RNFL thickness at 7th postop. day	96.23 (16.39)	87.07 (10.79)
RNFL thickness at 30th postop. day	96.09 (21.59)	87.93 (11.14)
RNFL thickness at 90th postop. day	97.56 (23.72)	87.37 (11.51)
RNFL thickness at 180th postop. day	100.40 (23.35)	88.93 (11.67)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
STUDY EYES	0 of 57 (0%)	0 of 57 (0%)	Not reported
CONTROL EYES	0 of 57 (0%)	0 of 57 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9917800Honavar 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. doi: 10.1016/S0161-6420(99)90017-9.
Background: PubMed 15650603Al-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. doi: 10.1097/01.ijg.0000145811.62095.fa.
Background: PubMed 11244337Mastropasqua 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. doi: 10.1159/000050836.
Background: PubMed 19464061Leung 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.
Background: PubMed 12782844Kee 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. doi: 10.1097/00061198-200306000-00012.
Background: PubMed 15289130Wollstein 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. doi: 10.1016/j.ajo.2004.03.019.
Background: PubMed 16949444Shah 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. doi: 10.1016/j.ophtha.2006.06.004.
Background: PubMed 19142136Yalvac 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.
Background: PubMed 19174720Inoue 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.
Derived from this study: PubMed 25510920Zoric Geber M, Bencic G, Vatavuk Z, Ivekovic R, Friberg TR. Retinal nerve fibre layer thickness measurements after successful retinal detachment repair with silicone oil endotamponade. Br J Ophthalmol. 2015 Jun;99(6):853-8. doi: 10.1136/bjophthalmol-2014-305839. Epub 2014 Dec 15.

Related trials for Rhegmatogenous Retinal Detachment

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Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mia Zoric Geber, MD principal investigator

University department of Ophthalmology, University Hospital "Sestre milosrdnice"

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rhegmatogenous Retinal Detachment and Toxic Effect of Silicone, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01255306, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2012.