Cystoid Macular Edema (CME) after cataract surgery
Conditions
Interventions
Trade Name: Yellox
Product Name: Bromfenac
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: BROMFENAC
CAS Number: 91714-94-2
Other descriptive name: Yellox
Concentration unit: mg/ml milli
Sponsors
University Eye Clinic Maastricht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients undergoing routine phacoemulsification. Only one eye per patient will be included in the study. Patients should be able to communicate properly and understand instructions. All patients must accept possible off-label use of study medication before inclusion in this study. 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 208 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 927
Exclusion criteria
Exclusion criteria: Study procedures will be different for diabetic and non-diabetic patients. Therefore, the exclusion criteria will also be different for diabetic and non-diabetic patients. General Eexclusion criteria for participation in this study are: 1. age below 21 years old; 2. participation in another clinical study; 3. post-traumatic cataract; 4. combined surgery; 5. functional monoculus; 6. previous ocular surgery; 7. progressive glaucoma with severe visual field defects, use of anti-glaucomatous medication or steroid-induced IOP elevation that required IOP-lowering treatment; 8. IOP = 25 mmHg; 9. history of intraocular inflammation or uveitis; 10. history of pseudoexfoliation syndrome, which is expected to cause peroperative complications; 11. history of Fuchs' endothelial dystrophy or cornea guttata 3+; 12. history of retinal vein occlusion; 13. any macular pathology that might influence VA, other than DME 14. use of intravitreal bevacizumab or ranibizumab in the previous 6 weeks or intravitreal aflibercept in the previous 10 weeks; 15. use of intra- or periocular corticosteroid injection in the previous 4 months; 16. current use of topical NSAIDs or corticosteroids; 17. use of systemic corticosteroids (= 20 mg prednisolone or equivalence); 18. history of relevant adverse events, including serious adverse events (SAE), occurring after administration of NSAIDs, acetylsalicylic acid, sodium sulphite, corticosteroids or bevacizumab; 19. contraindications for use of topical NSAIDs, topical or subconjunctival corticosteroids or intravitreal bevacizumab or related drugs Non-diabetic patients with a history of CME will be excluded from participation in the study. Additionally, diabetic patients will be excluded from participation in case of: 1. macular edema with a CSMT =450 µm; 2. very severe NPDR or proliferative DR requiring panretinal photocoagulation or vitrectomy; 3. vitreous haemorrhage present during preoperative visit(s); 4. cerebrovascular accident (CVA), myocardial infarction (MI) or other thromboembolic events in the previous 3 months; 5. a history of recurrent thromboembolic events; 6. a history of severe systemic bleeding in the previous 3 months; 7. major surgery in the previous 3 months; 8. history of glaucoma;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint is the change in central subfield mean macular thickness (CSMT) as compared to baseline at 6 weeks postoperatively. ;Secondary Objective: The secondary endpoint is the occurrence of postoperative clinically significant macular edema (CSME) within 12 weeks postoperatively. Other study endpoints are: mean CDVA in logMAR at 6 and 12 weeks postoperatively; CSMT 12 weeks postoperatively; OCT measured average retinal thickness in the inner circle (3mm), the outer circle (6mm), and the macular volume at 6 and 12 weeks postoperatively; intraocular pressure at 6 and 12 weeks postoperatively; health-related and vision-related quality of life at 12 weeks postoperatively; incremental cost-effectiveness ratios of the costs per quality-adjusted life year (QALY) and costs per improved patient on the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) and Health Utility Index (HUI-3).;Primary end point(s): Central subfield macular thickness (CSMT) on OCT;Timepoint(s) of evaluation of this end point: Baseline (preoperative or one day postoperative if preoperative OCT was of insufficient quality), 6 and 12 weeks postoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The occurrence of postoperative clinically significant macular edema within 12 weeks postoperative Best corrected visual acuity (BCVA) Intraocular pressure (IOP) Health-related and vision-related quality of life Adverse events;Timepoint(s) of evaluation of this end point: Preoperative and 6 and 12 weeks postoperative | — |
Countries
Austria, Belgium, Germany, Hungary, Netherlands, Portugal, Spain
Contacts
Public ContactLaura H.P. Wielders, PhD student
University Eye Clinic Maastricht
Outcome results
None listed