The efficacy and safety of Acular eyedrops or a singular Volon A 40 injection compared to a no treatment group in patients with macular edema (swelling of the retina due to accumulation of fluid) following cataract (clouding of the eye lens) surgery.
- Conditions
- Pseudophakic macular edemaTherapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]
- Registration Number
- EUCTR2016-003232-21-AT
- Lead Sponsor
- Medizinische Universität Graz, Univers. Augenklinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 249
- =18 years of age
-Pseudophakia in the study eye
-No history of previous treatment of PME
-Signed written informed consent
-Cataract surgery =4 months in study eye
-BCVA =20/125; BVCA =20/32
-Presence of PME determined by fundus examination
-Presence of central macular edema determined by OCT
-No sign of significant diabetic retinopathy and/or maculopathy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 224
-Pregnancy /Breast-feeding
-Systemic treatment with corticosteroids in the preceding 14 days
-Systemic treatment with NSAIDs in the preceding 14 days
-Presence of any contradictions indicated in the summary of product characteristics for the use of topical ketorolac tromethamine 0.5% and subtenon triamcinolone acetonide injection
-Active choroidal neovascularization
-Retinal detachment
-Vitreoretinal surgery in the preceding year
-Myopia =8 diopters
-Uncontrolled glaucoma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method