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

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.

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.