Cystoid Macular Edema, Cataract, Diabetes Mellitus
Conditions
Keywords
Prevention
Brief summary
Cystoid macular edema (CME) is a common cause of vision loss after cataract surgery. In the last few years, several new treatments have been tried to address the problem of CME after cataract surgery in diabetic and non-diabetic patients. The investigators will perform a large RCT with the aim to provide more definite evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes mellitus (DM).
Detailed description
The objective of this study is to evaluate the effect of different preventive strategies on the occurrence of CME after cataract surgery in non-diabetic and diabetic patients. The design of the study is a multicentre randomised controlled clinical trial. The study population will consist of 926 non-diabetic patients and 209 patients with diabetes mellitus (DM) who require cataract surgery in at least one eye. All patients will receive a phacoemulsification for cataract and placement of a posterior chamber intraocular lens (IOL). In the non-diabetic population, the patients will receive either bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperative, dexamethasone 0.1% eye drops four times daily starting two days before surgery and continuing four times daily during the first postoperative week and one drop less per day every following week or a combination of both drugs. In the diabetic population patients will receive either: * Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose; * Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose and a subconjunctival injection of 40 mg triamcinolone acetonide; * Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose and an intravitreal injection of 1.25 mg bevacizumab; * Topical bromfenac 0.09% and dexamethasone 0.1% in the aforementioned dose, a subconjunctival injection of 40 mg triamcinolone acetonide and an intravitreal injection of 1.25 mg bevacizumab. The primary endpoint is the change in central subfield mean macular thickness in the 1 mm area (central subfield macular thickness, CSMT) as compared to baseline within the first 6 weeks postoperative. 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 weeks and 12 weeks postoperatively; OCT measured average retinal thickness in the central inner circle (3mm), the outer circle (6mm), and the macular volume at 6 weeks and 12 weeks postoperatively; intraocular pressure at 6 weeks and 12 weeks postoperatively. In case of clinically significant macular edema, treatment will be initiated and its effect will be part of the evaluation at 12 weeks. Medical data of all patients who develop macular edema during this study will be checked at least 6 months after surgery.
Interventions
Sponsors
European Society of Cataract and Refractive Surgeons
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients undergoing routine phacoemulsification (one eye per patient) * willing and/or able to comply with the scheduled visits and other study procedures. * able to communicate properly and understand instructions. * accepting possible off-label use of intravitreal bevacizumab and/or subconjunctival preservative-free TA.
Exclusion criteria
will be different for non-diabetic and diabetic patients. All ophthalmic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in central subfield mean macular thickness as a measurement of efficacy | 6 weeks postoperatively | The primary endpoint is the change in central subfield mean macular thickness in the 1 mm area (central subfield macular thickness, CSMT) as compared to baseline within the first 6 weeks postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No. of subjects developing clinically significant macular edema as a measurement of efficacy | 12 weeks postoperatively | The secondary endpoint is the occurrence of postoperative clinically significant macular edema (CSME) within 12 weeks postoperatively. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure (IOP) as a measurement of safety | 6 postoperatively | IOP (in mmHg) will be measured by Goldmann applanation tonometry |
| Health-related quality of life as a measurement of efficacy and tolerability | 12 weeks postoperatively | Using the Health Utility Index mark 3 (HUI-3) |
| No. of subjects with Adverse Events as a measurement of safety and tolerability | 6 weeks postoperatively | An adverse event (AE) is defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the investigational product. All adverse events reported spontaneously by the subject or observed by the principal investigator or his staff will be recorded. Most frequently reported adverse events which might occur while using the study medication: abnormal sensation in the eye, pain or irritation, redness or headache while using eye drops; increased IOP and masking of infections while using corticosteroids; retinal detachment, thrombo-embolic events, endophthalmitis and anterior chamber reactions after intravitreal injections of bevacizumab. |
| Change in retinal thickness in the central outer circle (6mm) as a measurement of efficacy | 6 weeks postoperatively | Using OCT |
| Change in corrected distance visual acuity (CDVA) as a measurement of efficacy | 6 postoperatively | CDVA measurements will be taken using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts (logMAR). |
| Vision-related quality of life as a measurement of efficacy and tolerability | 12 weeks postoperatively | Using the National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ 25) |
| Cost-effectiveness | 12 weeks postoperatively | Incremental cost-effectiveness ratios of the costs per quality-adjusted life year (QALY) and costs per improved patient on the NEI VFQ-25 and HUI-3. |
| Change in central subfield mean macular thickness as a measurement of efficacy | 12 weeks postoperatively | Using OCT |
| Change in macular volume as a measurement of efficacy | 6 postoperatively | Using OCT |
| Change in retinal thickness in the central inner circle (3mm) as a measurement of efficacy | 6 weeks postoperatively | Measured using Optical Coherence Tomography (OCT) |
Countries
Austria, Belgium, Germany, Hungary, Netherlands, Portugal, Spain
Outcome results
None listed