Prevention of macular edema after cataract surgery
- Conditions
- cystoid macular edema (CME)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2019-004890-21-NL
- Lead Sponsor
- Academic Hospital Maastricht (azM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 808
Patients can be included who are undergoing routine phacoemulsification; who are 21 years or older; who should be able to communicate properly and understand instructions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 808
All ophthalmic exclusion criteria are applicable to the study eye only, unless stated otherwise. General exclusion criteria for participation in this study are: patients who already participated with their contralateral eye; combined surgery (e.g. combined phacoemulsification and trabeculectomy); patients with an increased risk of developing cystoid macular edema (CME) in the study eye (e.g. diabetes mellitus, Fuchs' endothelial dystrophy, previous retinal venous occlusion, or a history of uveitis, macular edema, epiretinal membrane, or previous retinal surgery); patients who developed CME after cataract surgery in the contralateral eye; patients with cystoid macular changes in the study eye at baseline; patients with an increased risk of developing perioperative complications; patients with permanent moderate visual impairment in the contralateral eye (decimal visual acuity less than 0.3); patients with a history of steroid induced IOP rise or glaucomatous visual field loss; patients using drugs that reduce or increase the risk of macular edema (e.g., perioculair or intraocular corticosteroid, NSAID, or antivascular endothelial growth factor (VEGF) injection; topical corticosteroid or NSAID use; systemic corticosteroids (>= 20mg prednisolon), methotrexate, biologicals, or acetazolamide), or in the previous 4 months; patients with a contraindication for any of the investigated drugs; patients who are cardiovascular unstable; patients who have a history of hyperthyroidism.
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