search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number10281
- NTR NumberNTR3046
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-aug-2011
- Secondary IDs2009-09 / 2011-259 / NL37200.078.11; OZR / MEC / CCMO
- Public TitleIs Intentional Continuous Shallowing of the Anterior Chamber (ICSAC) a safe procedure? Does it cause endothelial cell damage?
- Scientific TitleIs Intentional Continuous Shallowing of the Anterior Chamber (ICSAC) a safe procedure? Does it cause endothelial cell damage?
- ACRONYMICSAC
- hypothesisIntentional continuous shallowing of the anterior chamber (ICSAC) does not harm the corneal endothelium.
- Healt Condition(s) or Problem(s) studiedMacular pucker, Macular hole, Vitreous opacities, Vitrectomy
- Inclusion criteria1. Age 18 years;
2. Informed consent;
3. Requiring vitrectomy for floaters, macular pucker or macular hole.
- Exclusion criteria1. Vitrectomy procedure is anticipated to be complicated;
2. ECD < 2000 mm-2;
3. Pseudophakia.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate1-mrt-2013
- Target number of participants50
- InterventionsVitrectomy with ICSAC versus vitrectomy without ICSAC.
- Primary outcomeEndothelial cell density (ECD) at 1 and 3 months.
- Secondary outcome1. 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.).
- TimepointsBaseline, 1, 3 and 6 months.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. J.C. Meurs, van
- CONTACT for SCIENTIFIC QUERIESDr. J.C. Meurs, van
- Sponsor/Initiator The Rotterdam Eye Hospital
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek Oogziekenhuis Prof. Dr. Flieringa (SWOO)
- PublicationsMulder 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. PMID: 26268072
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD26-aug-2011 - 27-jan-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl