|- candidate number||7922|
|- NTR Number||NTR2280|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-apr-2010|
|- Secondary IDs||OZR-2009-06 MEC-2010-008|
|- Public Title||Treatment of Cystoid Macular Edema following cataract surgery. A randomized, double-masked, placebo-controlled, clinical trial.
|- Scientific Title||Treatment of Cystoid Macular Edema following cataract surgery. A randomized, double-masked, placebo-controlled, clinical trial.
|- hypothesis||Treatment with Nevanac in combination with Pred Forte of Cystoid Macular Edema after phacoemulsification is superior to placebo.|
|- Healt Condition(s) or Problem(s) studied||Cystoid Macular Edema (CME), Phacoemulsification|
|- Inclusion criteria||1. Diagnosed or suspect clinical CME within three months after phacoemulsification;|
2. CME on OCT;
3. Age > 18 years;
4. Informed consent;
5. Patients must be able to comply with the study protocol.
|- Exclusion criteria||1. Diabetes mellitus I/II;|
2. Corneal complications;
3. Age related macula degeneration (wet and dry);
4. History of retinal detachment;
5. History of vitrectomy;
6. Macular disease;
7. History of steroid response (IOP-rise);
8. Hypersensitivity to NSAIDs / NSAID-induced asthma;
9. Use of systemic steroid medication / NSAIDs;
11. M. Addison / adrenal gland failure;
12. Chronic angle-closure glaucoma;
13. Complicated cataract operation;
14. Keratoconjunctivitis sicca;
15. Rheumatoid arthritis.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2010|
|- planned closingdate||29-feb-2012|
|- Target number of participants||120|
|- Interventions||1. Group 1: Placebo eyedrops in two separate phials;|
2. Group 2: 6 weeks treatment of nepafenac 0,1% eye drops 3 times a day (d.d.), plus prednisolone acetate 1% eye drops 3 d.d.
|- Primary outcome||At 12 weeks:|
1. Optical Coherence Tomography (OCT)-proven CME (yes/no);
2. Best corrected visual acuity as determined by ETDRS.
|- Secondary outcome||1. OCT-proven CME (yes/no);|
2. Clinical CME (yes/no) (i.e CME with reduced visual acuity of 2 or more lines);
3. Best corrected visual acuity as determined by ETDRS;
4. Thickness of the macula, examined by OCT RTVue (Optovue);
5. Active inflammation as measured by Laser flare count
|- Timepoints||4, 8,12, 20, 52 weeks.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||drs. P.W.T. Waard, de|
|- CONTACT for SCIENTIFIC QUERIES||drs. P.W.T. Waard, de|
|- Sponsor/Initiator ||Oogziekenhuis Rotterdam (OZR)|
(Source(s) of Monetary or Material Support)
|Stichting Wetenschappelijk Onderzoek het Oogziekenhuis|
|- Brief summary||Rationale: |
Cataract extraction is the most frequently performed surgical intervention. One of the most common causes of poor visual acuity after cataract surgery is the development of postoperative clinical (cystoid) macular edema ((C)ME). Several treatment options have been investigated, but a uniform treatment protocol does not exist.
The current treatment strategies range from no to very intensive treatment with no strategy showing unambiguous benefits. However, based on our experience and extensive literature review, it is likely that a treatment using local application of a corticosteroid and a non-steroidal anti-inflammatory drug will be optimal. Therefore, the efficacy of treatment of CME with a combination of these types of drug will be investigated.
To study the efficacy of treatment with Nevanac in combination with Pred Forte of Cystoid Macular Edema after phacoemulsification.
Prospective randomized double-masked placebo-controlled clinical trial.
Patients diagnosed with clinical CME within three months after phacoemulsification.
Group 1: Placebo eyedrops in two separate phials.
Group 2: 6 weeks treatment of nepafenac 0,1% eye drops 3 d.d., plus prednisolone acetate 1% eye drops 3 d.d.
Main study parameters/endpoints:
Before treatment and 4, 8, 12, 20 and 52 weeks after treatment has started:
1. Prevalence of (C)ME;
2. Best Corrected Visual Acuity by ETDRS;
3. Inflammation parameter (Laser flare count) by Laser Flare Meter;
4. Thickness of the macula, by OCT.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There are no risks involved for patients in group 1; possible side effects of medication used in this study (group 2) can be found in the respective SPC's. Six study-related visits are scheduled, which will take 30 minutes each. Measurements are not invasive; burden is low.
|- Main changes (audit trail)|
|- RECORD||12-apr-2010 - 27-jan-2016|