Trial Outcomes & Findings for The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy (NCT NCT01255306)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

6 months

Results posted on

2012-03-23

Participant Flow

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.

We excluded one patient who developed severe inflammatory reaction 5 days following pars plana vitrectomy and silicone oile tamponade from the study.

Participant milestones

Participant milestones
Measure	NO IOP Patients without raised IOP	RAISED IOP Patients with raised IOP
Overall Study STARTED	26	33
Overall Study COMPLETED	25	32
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	NO IOP Patients without raised IOP	RAISED IOP Patients with raised IOP
Overall Study Physician Decision	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NO IOP n=26 Participants Patients without raised IOP	RAISED IOP n=33 Participants Patients with raised IOP	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	25 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	8 Participants n=7 Participants	23 Participants n=5 Participants
Age Continuous	63.80 years STANDARD_DEVIATION 12.97 • n=5 Participants	58.21 years STANDARD_DEVIATION 12.26 • n=7 Participants	60.67 years STANDARD_DEVIATION 12.77 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	22 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment Croatia	26 participants n=5 Participants	33 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	STUDY EYES n=57 eyes Study eyes that underwent pars plana vitrectomy and silicone oil tamponade	CONTROL EYES n=57 eyes Fellow eye of each patient	CONTROL Fellow eye of each patient
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	87.07 micrometer Standard Deviation 10.79	—
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	87.93 micrometer Standard Deviation 11.14	—
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	87.37 micrometer Standard Deviation 11.51	—
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	88.93 micrometer Standard Deviation 11.67	—

SECONDARY outcome

Timeframe: 6 months

Population: We included all patients who completed follow up visits and who had valid OCT measurements as defined per protocol.

To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade.

Outcome measures

Outcome measures
Measure	STUDY EYES n=50 eyes Study eyes that underwent pars plana vitrectomy and silicone oil tamponade	CONTROL EYES n=64 eyes Fellow eye of each patient	CONTROL n=57 eyes Fellow eye of each patient
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	96.34 micrometer Standard Deviation 17.51	87.07 micrometer Standard Deviation 10.79
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	97.91 micrometer Standard Deviation 24.35	87.93 micrometer Standard Deviation 11.14
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	98.44 micrometer Standard Deviation 24.53	87.37 micrometer Standard Deviation 11.51
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 23.00	99.34 micrometer Standard Deviation 23.93	88.93 micrometer Standard Deviation 11.67

Adverse Events

STUDY EYES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CONTROL EYES

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mia Zoric Geber, MD

University Hospital "Sestre milosrdnice"

Phone: +385 1 3787 354

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place