Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments

Diabetic Retinopathy Clinical Trial

Official title:

A Prospective, Randomized Study Comparing 1000 Centistoke and 5000 Centistoke Silicone Oil Tamponade for Repair of Proliferative Vitreoretinopathy Retinal Detachments and Diabetic Tractional Retinal Detachments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255293
• Other study ID #: MAR-3
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: June 13, 2013
• Start date: November 2010
• Est. completion date: October 2012

Study information

• Verified date: June 2013
• Source: Mid Atlantic Retina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the retinal redetachment rates with 1000 centistoke versus 5000 centistoke silicone oil tamponade for repair of complex retinal detachments.

Description:

As part of retinal detachment surgery, the eye is typically filled with a gas bubble or silicone oil bubble. This bubble acts like a balloon inside the eye and helps to keep the retina pushed back against the eye wall so it can heal in its proper place. Gas bubbles spontaneously dissolve over a few weeks whereas silicone oil remains in the eye until removed with another surgery. When retinal detachments are associated with significant scar tissue on the retinal surface, silicone oil is often used since it can remain filling the eyeball for as long as necessary to help the retina to heal properly in place. Currently, two different types of silicone oil (1000 centistoke and 5000 centistoke) are commercially available and have been approved for use in the eye by the Food and Drug Administration. The goal of the study is to compare the outcomes using these two different types of silicone oil.

The retinal detachment will be repaired in a standard fashion. There will be no difference between the way retinal detachments are repaired in this study compared to those not in this study. Patients will be randomly assigned (like a flip of a coin) to receive one of the types of silicone oil. Both types of oil have very similar characteristics. The primary difference is that one type is thicker (more viscous) than the other, analogous to honey in comparison with maple syrup.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Presence of rhegmatogenous retinal detachment or tractional retinal detachment due to grade C or worse proliferative vitreoretinopathy or proliferative diabetic retinopathy.

• Judgment by the investigator that silicone oil tamponade is surgically indicated for appropriate repair of the complex retinal detachment.

• Visual acuity of light perception or better.

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

• Inability to re-attach the retina at the time of surgery.

• Prior trabeculectomy or tube shunt surgery.

• Corneal opacity which limits visualization of the trabecular meshwork.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Dissociative Disorders
• Proliferative Vitreoretinopathy
• Retinal Detachment
• Retinal Diseases
• Vitrectomy

Intervention

Procedure:
• 1000 centistoke silicone oil
Patients who are enrolled in the study and have been identified to have a complex retinal detachment requiring silicone oil tamponade may be randomly assigned to receive 1000 centistoke silicone oil.
• 5000 centistoke silicone oil
Patients who are enrolled in the study and have been identified to have a complex retinal detachment requiring silicone oil tamponade may be randomly assigned to receive 5000 centistoke silicone oil

Locations

Country	Name	City	State
United States	Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Mid Atlantic Retina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal redetachment rate		Six months	No
Secondary	Best-corrected visual acuity		6 and 12 months	No
Secondary	Silicone oil emulsification rate	Gonioscopy examination will be used at monthly postoperative visits to assess silicone oil emulsification in each patient.	Monthly	No