No registrations found.
ID
Source
Brief title
Health condition
Macular pucker, macular hole and vitreous opacities requiring vitrectomy.
Sponsors and support
PO Box 70030
NL-3000-LM Rotterdam
010-4017777
Intervention
Outcome measures
Primary outcome
Endothelial cell density (ECD) at 1 and 3 months.
Secondary outcome
1. ECD at 6 months;
2. Anterior Chamber Depth at 3 and 6 months;
3. Corneal Topography at 3 and 6 months;
4. Best corrected visual acuity;
5. Intraocular pressure;
6. Gonioscopy;
7. Complications (retinal defects, retinal detachment, etc.).
Background summary
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.
Study objective
Intentional continuous shallowing of the anterior chamber (ICSAC) does not harm the corneal endothelium.
Study design
Baseline, 1, 3 and 6 months.
Intervention
Vitrectomy with ICSAC versus vitrectomy without ICSAC.
Schiedamsevest 180
J.C. Meurs, van
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
vanMeurs@oogziekenhuis.nl
Schiedamsevest 180
J.C. Meurs, van
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
vanMeurs@oogziekenhuis.nl
Inclusion criteria
1. Age ¡Ý 18 years;
2. Informed consent;
3. Requiring vitrectomy for floaters, macular pucker or macular hole.
Exclusion criteria
1. Vitrectomy procedure is anticipated to be complicated;
2. ECD < 2000 mm-2;
3. 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 |
|---|---|
| NTR-new | NL2900 |
| NTR-old | NTR3046 |
| Other | OZR / MEC / CCMO : 2009-09 / 2011-259 / NL37200.078.11; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
the anterior chamber, a procedure to prevent lens touch during phakic vitrectomy. Acta Ophthalmol.
2015; Epub: Aug 13.
PMID: 26268072