|- candidate number||10281|
|- NTR Number||NTR3046|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-aug-2011|
|- Secondary IDs||2009-09 / 2011-259 / NL37200.078.11; OZR / MEC / CCMO|
|- Public Title||Is Intentional Continuous Shallowing of the Anterior Chamber (ICSAC) a safe procedure? Does it cause endothelial cell damage?|
|- Scientific Title||Is Intentional Continuous Shallowing of the Anterior Chamber (ICSAC) a safe procedure? Does it cause endothelial cell damage?|
|- hypothesis||Intentional continuous shallowing of the anterior chamber (ICSAC) does not harm the corneal endothelium.|
|- Healt Condition(s) or Problem(s) studied||Macular pucker, Macular hole, Vitreous opacities, Vitrectomy|
|- 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;
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2011|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||50|
|- Interventions||Vitrectomy with ICSAC versus vitrectomy without ICSAC.|
|- 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;
7. Complications (retinal defects, retinal detachment, etc.).
|- Timepoints||Baseline, 1, 3 and 6 months.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.C. Meurs, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.C. Meurs, van|
|- Sponsor/Initiator ||The Rotterdam Eye Hospital|
(Source(s) of Monetary or Material Support)
|Stichting Wetenschappelijk Onderzoek Oogziekenhuis – Prof. Dr. Flieringa (SWOO)|
|- Publications||Mulder V, Veckeneer M, van Rooij J, Delaey C, van Meurs JC. Intentional continuous shallowing of
the anterior chamber, a procedure to prevent lens touch during phakic vitrectomy. Acta Ophthalmol.
2015; Epub: Aug 13.
|- Brief 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.
To compare the effect on the corneal endothelium of ICSAC during vitrectomy.
Randomized, comparative, open-label, parallel.
Patients requiring vitreoretinal surgery.
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.
|- Main changes (audit trail)|
|- RECORD||26-aug-2011 - 27-jan-2016|