PRevention of Macular EDema After Cataract Surgery
Overview
- Phase
- Phase 3
- Intervention
- Bromfenac
- Conditions
- Cystoid Macular Edema
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 1127
- Locations
- 16
- Primary Endpoint
- Change in central subfield mean macular thickness as a measurement of efficacy
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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 exclusion criteria are applicable to the study eye only, unless stated otherwise.
- •General exclusion criteria for participation in this study are:
- •age below 21 years old;
- •participation in another clinical study;
- •post-traumatic cataract;
- •combined surgery;
Exclusion Criteria
- Not provided
Arms & Interventions
Non diabetics: bromfenac
bromfenac 0.09% eye drops twice daily starting two days before surgery and continuing 2 weeks postoperatively
Intervention: Bromfenac
Non diabetics: dexamethasone
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
Intervention: Dexamethasone
Non diabetics: bromfenac & dexamethasone
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
Intervention: Bromfenac
Non diabetics: bromfenac & dexamethasone
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
Intervention: Dexamethasone
Diabetics: eye drops
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
Intervention: Bromfenac
Diabetics: eye drops
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
Intervention: Dexamethasone
Diabetics: eye drops & TA
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 \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA, Triesence/Vistrec)
Intervention: Bromfenac
Diabetics: eye drops & TA
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 \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA, Triesence/Vistrec)
Intervention: Dexamethasone
Diabetics: eye drops & TA
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 \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA, Triesence/Vistrec)
Intervention: Triamcinolone Acetonide
Diabetics: eye drops & bevacizumab
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 \& a peroperative intravitreal injection of 1.25 mg bevacizumab (Avastin)
Intervention: Bromfenac
Diabetics: eye drops & bevacizumab
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 \& a peroperative intravitreal injection of 1.25 mg bevacizumab (Avastin)
Intervention: Dexamethasone
Diabetics: eye drops & bevacizumab
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 \& a peroperative intravitreal injection of 1.25 mg bevacizumab (Avastin)
Intervention: Bevacizumab
Diabetics: eye drops, TA & bevacizumab
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 \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA) \& a peroperative intravitreal injection of 1.25 mg bevacizumab
Intervention: Bromfenac
Diabetics: eye drops, TA & bevacizumab
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 \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA) \& a peroperative intravitreal injection of 1.25 mg bevacizumab
Intervention: Dexamethasone
Diabetics: eye drops, TA & bevacizumab
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 \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA) \& a peroperative intravitreal injection of 1.25 mg bevacizumab
Intervention: Bevacizumab
Diabetics: eye drops, TA & bevacizumab
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 \& a peroperative subconjunctival injection of 40 mg triamcinolone acetonide (TA) \& a peroperative intravitreal injection of 1.25 mg bevacizumab
Intervention: Triamcinolone Acetonide
Outcomes
Primary Outcomes
Change in central subfield mean macular thickness as a measurement of efficacy
Time Frame: 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 Outcomes
- No. of subjects developing clinically significant macular edema as a measurement of efficacy(12 weeks postoperatively)