|- candidate number||23471|
|- NTR Number||NTR5591|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-dec-2015|
|- Secondary IDs||METc 2015/500 METc UMCG|
|- Public Title||Light on glaucoma: pilot study|
|- Scientific Title||Light on glaucoma: pilot study to measure contrast sensitivity, visual field, and adaptation time at high light conditions.|
|- hypothesis||The objectives of this pilot are |
(1) to test and develop an experimental setup to determine contrast sensitivity, visual field and adaptation time at high light conditions.
(2) To perform a pilot study with 10 healthy subject.
|- Healt Condition(s) or Problem(s) studied||Glaucoma|
|- Inclusion criteria||Healthy subjects will consist of people (age 18-70) who have signed in, without ophthalmic abnormalities and provide written informed consent.|
|- Exclusion criteria||- Subjects with an eye disease.|
- Subjects with a first degree relative with glaucoma, or with high eye pressure in the past.
- Visual acuity below 1.0 (below 50 years of age) or below 0.8 (above 50 years of age).
- Visual field defects which are not understood.
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-jan-2016|
|- planned closingdate||1-jul-2016|
|- Target number of participants||10|
|- Primary outcome||Measurement of contrast sensitivity, visual field and adaptation time at high light conditions. |
|- Secondary outcome||None|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||R.A.J.M. Bierings|
|- CONTACT for SCIENTIFIC QUERIES||R.A.J.M. Bierings|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||9-dec-2015 - 14-feb-2016|