Is Intentional Continuous Shallowing of the Anterior Chamber (ICSAC) a safe procedure? Does it cause endothelial cell damage?

Rationale:

Removal of vitreous near sclerotomies without touching the lens is facilitated by intentional continuous shallowing of the anterior chamber (ICSAC). Thus, the risk of sclerotomy related complications can be reduced. It is unknown, however, whether ICSAC poses a risk to the corneal endothelium.



Objective:

To compare the effect on the corneal endothelium of ICSAC during vitrectomy.



Study design:

Randomized, comparative, open-label, parallel.



Study population:

Patients requiring vitreoretinal surgery.



Intervention:

ICSAC during vitrectomy versus no ICSAC during vitrectomy.



Main study parameters/endpoints:

Endothelial cell density at 1 and 3 months.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Exclusively study-related assessments are performed during regular visits and take about 20 minutes extra time (i.e. 80 minutes in total); risks involved are negligible. The risk of sclerotomy related complications is supposedly less in the ICSAC group, but the risk of increased loss of endothelial cells may be higher. Treatment of the control group comprises a conventional vitrectomy procedure.

Intentional continuous shallowing of the anterior chamber (ICSAC) does not harm the corneal endothelium.

Baseline, 1, 3 and 6 months.

Vitrectomy with ICSAC versus vitrectomy without ICSAC.