|- candidate number||22901|
|- NTR Number||NTR5417|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-sep-2015|
|- Secondary IDs||4313 MEC|
|- Public Title||Selective laser trabeculoplasty (SLT) as replacement therapy in glaucoma patients|
|- Scientific Title||Selective laser trabeculoplasty as replacement therapy in glaucoma patients|
|- hypothesis||1. does pseudophakia influence intra ocular pressure (IOP) lowering effect of SLT? |
2. the effect of SLT relies on an inflammatory reaction. Anti-inflammatory therapy is often used immediately following SLT, does this influence the IOP lowering effect or the side effects after SLT?
3. anti-glaucoma eye drops have a lot of side effects. Does SLT improve quality of life by reducing number of eye medications?
4. is there a significant difference in IOP lowering effect of SLT in low, normal or high tension glaucoma?
|- Healt Condition(s) or Problem(s) studied||Glaucoma, Laser treatment|
|- Inclusion criteria||patients with ocular hypertension or chronic open angle glaucoma controlled by medical therapy. Patients had to be prepared to sign an informed consent document.|
|- Exclusion criteria||other types of glaucoma than open angle glaucoma, previous trabeculectomy or selective laser trabeculoplasty. Corneal disease that inhibit good visualization of the trabecular meshwork and patients taking systemic steroids are excluded|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||1-sep-2016|
|- Target number of participants||145|
|- Interventions||1,Randomization decides whether patients receive SLT or continue on drops.|
2,In those to receive SLT, randomization decides whether indomethacin or dexamethasone drops are given after SLT.
3,SLT is applied in both eyes, randomization decides in which eye the anti-inflammatory therapy (indomethacin or dexamethasone) is given, we start SLT always at the right eye.
4, SLT is performed, right eye first, the week after that, the other eye is treated. Eye that does not receive anti-inflammatory therapy is control eye.
|- Primary outcome||1, IOP lowering effect of SLT
|- Secondary outcome||1, inflammatory parameters after SLT ( redness, pain, cells in anterior chamber, IOP spike)|
2, quality of life parameters
|- Timepoints||start, 1 hour, 1 week, 1, 3, 6 and 12 months after SLT|
|- Trial web site||none|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Myrjam de Keyser|
|- CONTACT for SCIENTIFIC QUERIES|| Myrjam de Keyser|
|- Sponsor/Initiator ||dr. M. De Keyser|
(Source(s) of Monetary or Material Support)
|Universitair Ziekenhuis van Antwerpen|
|- Brief summary||Glaucoma is a very common chronic disease. Selective laser trabeculoplasty (SLT) has the advantage of eliminating the side effects that are very common after using anti-glaucoma eye drops. We aim to investigate several aspects of SLT|
|- Main changes (audit trail)|
|- RECORD||23-sep-2015 - 29-okt-2015|