To compare the effect on the corneal endothelium of ICSAC during vitrectomy.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endothelial cell density at 1 and 3 months.
Secondary outcome
ECD at 6 months.
IOP.
Depth anterior chamber.
BCVA.
Complications.
Background summary
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.
Study objective
To compare the effect on the corneal endothelium of ICSAC during vitrectomy.
Study design
Randomized, comparative, open-label, parallel.
Intervention
ICSAC during vitrectomy versus no ICSAC during vitrectomy.
Study burden and risks
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.
Schiedamse Vest 180
3011 BH Rotterdam
NL
Schiedamse Vest 180
3011 BH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years.
- Informed consent.
- Requiring vitrectomy for floaters, macular pucker or macular hole.
Exclusion criteria
- Vitrectomy procedure is anticipated to be complicated.
- ECD < 2000 mm-2
- Pseudophakia.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37200.078.11 |