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)


The use of neutral density filters in PlusoptiX devices.


- candidate number9141
- NTR NumberNTR2767
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-feb-2011
- Secondary IDsMETC 10-120 METC Medisch Centrum Haaglanden
- Public TitleThe use of neutral density filters in PlusoptiX devices.
- Scientific TitleA study to the determine the use of neutral density filter for reliable measurements in very large pupils in use of the plusoptiX software, and the influence of those filters on outcomes.
- ACRONYMPlusoptiX & ND filters.
- hypothesisThe software of the PlustoptiX devices is developed for pupils up to 7.8 to 8mm in size. In the study ďa double blind randomized study on the efficacy of cyclopentolate 1% and tropicamide 1% in children (MEC nr NL32954.098 /1010-077; NTR 2476), pupil sizes will be over 8mm in a considerable amount of cases. To avoid drop-out neutral density filters are used to decrease light intensity. This study will investigate the validity of the use of neutral density. Further the optimal filter will be determined.
- Healt Condition(s) or Problem(s) studiedPupil size, Refractive outcome, Score of neutral density filter
- Inclusion criteriaUn-dilated pupils:
Healthy volunteers, aged 35 to 60 years, having hypermetropia corrected with unifocal glasses, visiting the department Ophthalmology either as a patient or as an accompanying person.

Dilated pupils:
Healthy volunteers, aged 18 to 60, having hypermetropia, which received cycloplegics.
- Exclusion criteriaFor both un-dilated and dilated subjects:
Cataract and/or vitreous bleeding, and/or abnormal shaped pupils or no oral consent.
For un-dilated subjects pupil sizes < 3.5 mm or > 7.8mm.
For dilated subjects pupil sizes <6mm.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2010
- planned closingdate1-apr-2011
- Target number of participants41
- InterventionsMeasurements are made with the Powerrefractor II; software installed of the PlustoptiX A09. Both for the un- and dilated: A entry measurement with and without glasses will be made. Thereafter three measurements will be made with glasses and consecutive neutral density filters. Five different absorptive neutral density filters will be used; 91% (Newport Ltd), 79% (Newport Ltd), 62% (Thorlabs Ltd), 46% (Thorlabs Ltd) and 34% (Thorlabs Ltd).
- Primary outcome1. Success and failure rates of the consecutive neutral density filters;
2. (Δ) SEQ values. Differences will be considered statistical significant if p<0.05.

A differences of 5% success rate (1) and >0.2 diopters Δ SEQ (1 and 2) will be considered clinical significant.
- Secondary outcomeN/A
- TimepointsFor both protocols: To prevent differences in pupil dynamics eligible subjects will be adapted to the room light for 5 minutes. During this time the purpose of the measurements will be explained, time investment (3 minutes) be discussed and oral consent asked. After consent measurements will be made. Success (data) or failure (no data) will be recorded. Pupil size, sfere, cylinder and axes of each measurement will be noted. Refractive outcomes will be converted in SEQ.

For the un-dilated protocol the measurements will be made in consecutive order; entry measurements without glasses, measurements with glasses, measurements with glasses and filter 91% etc.

For the dilated protocol the measurements will take place 35 minutes after application of the cycloplegics. The refractive state of the subject will be assessed with the Retinomax K-plus 3. The values found will be placed in a trial frame. Measurements will be made in consecutive order; entry measurements without trail glasses, measurements with trial glasses, measurements with trail glasses and filter 91% etc.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. H.M. (Ellen) Minderhout, van
- CONTACT for SCIENTIFIC QUERIESMSc. H.M. (Ellen) Minderhout, van
- Sponsor/Initiator Medisch Centrum Haaglanden
- Funding
(Source(s) of Monetary or Material Support)
Zorgvernieuwingsproject; zorgverzekeraars
- PublicationsN/A
- Brief summaryThe software of the PlustoptiX devices is developed for pupils up to 7.8 to 8mm in size. In the study ďa double blind randomized study on the efficacy of cyclopentolate 1% and tropicamide 1% in children (MEC nr NL32954.098 /1010-077; NTR 2476), pupil sizes will be over 8mm in a considerable amount of cases. To avoid drop-out neutral density filters are used to decrease light intensity. This study will investigate the validity of the use of neutral density. Further the optimal filter will be determined.
- Main changes (audit trail)
- RECORD23-feb-2011 - 4-mrt-2011


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