Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

• Sponsor: Khon Kaen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02988583
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 34
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

Silicone oil has been used as a surgical tool in complicated retinal detachment surgery. There are some complications occurring in pars plana vitrectomy with silicone oil tamponade. Silicone oil emulsification is one of the complication that may result in severe sequels that are difficult to treat. It is believed that low viscosity silicone oil has more risk to develop emulsification than high viscosity silicone oil. Up to now, however, there is no conclusive guideline that which types of silicone oil is suitable for these complicated retinal detachment surgeries and what is the appropriate time to remove the oil. This prospective study aims to study the silicone oil emulsification comparing between low viscosity and high viscosity silicone oil after complicated retinal detachment surgery.

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment Rhegmatogenous	Device: Surgery using low viscosity silicone oil; Device: Surgery using high viscosity silicone oil	N/A

Detailed Description

Silicone oil has been used as a surgical tool in retinal detachment surgery since 1962. The National Eye Institute Silicone Study demonstrated the superiority of silicone oil compared with sulfur hexafluoride, and its comparability with perfluoropropane, for the treatment of complicated retinal detachment associated with advanced proliferative vitreoretinopathy. There are some complications occurring in pars plana vitrectomy with silicone oil tamponade. These complications may occur during surgery and after the surgery. Silicone oil emulsification is one of the complication that may result in severe sequels including band-shaped keratopathy, complicated glaucoma and retinopathy that are difficult to treat. The commonly used silicone oil includes low viscosity and high viscosity type. It is believed that low viscosity silicone oil has more risk to develop emulsification than high viscosity silicone oil. Up to now, however, there is no conclusive guideline that which types of silicone oil is suitable for these complicated retinal detachment surgeries and what is the appropriate time to remove the oil. Retrospective medical review of these patients using 1000-vs 5000-centistoke silicone oil demonstrated that anatomic and visual acuity outcomes, as well as complication rates including emulsification, were similar in both groups. To the best of authors' knowledge, there has been no prospective study on this subject. This study aims to study the silicone oil emulsification comparing between low viscosity and high viscosity silicone oil after complicated retinal detachment surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery: A Randomized Double-masked Clinical Trial
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low viscosity silicone oil Retinal detachment surgery using low viscosity silicone oil	Device: Surgery using low viscosity silicone oil; Pars plans vitrectomy using low viscosity silicone oil
Active Comparator: high viscosity silicone oil Retinal detachment surgery using high viscosity silicone oil	Device: Surgery using high viscosity silicone oil; Pars plans vitrectomy using high viscosity silicone oil

Outcome Measures

Primary Outcome Measures

1. Emulsification rate [12 months]

   Proportion of patients developing silicone oil emulsification in each arm/group.

Secondary Outcome Measures

1. Retina reattachment rate [12 months]

   Proportion of patients having retinal reattachment after surgery in each arm/group.

2. visual improvement [12 months]

   Proportion of patients having visual improvement after surgery in each arm/group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with diagnosis of complicated retinal detachment who underwent pars plana vitrectomy with intravitreal silicone oil tamponade

• Age ≥ 18 years

• Sign informed consent form

Exclusion Criteria:

• Inflammatory eye diseases i.e. uveitis

• Corneal scar

• History of scleral buckling procedure

• History of using surfactant drugs

• Glaucoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Srinagarind Hospital, Khon Kaen University	Khon Kaen		Thailand	40002

Sponsors and Collaborators

• Khon Kaen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
• ClinicalTrials.gov Identifier: NCT02988583
• Other Study ID Numbers: HE591018
• First Posted: Dec 9, 2016
• Last Update Posted: Aug 14, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Yosanan Yospaiboon, Professor, Khon Kaen University: silicone oil; emulsification; retinal detachment surgery
• Additional relevant MeSH terms: Retinal Detachment; Dissociative Disorders

Study Results

No Results Posted as of Aug 14, 2019