The objective of this study is to evaluate the effect of different preventive strategies on the occurrence of macular edema after cataract surgery in non-diabetic and diabetic patients.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 at 6 weeks postoperatively.
Secondary outcome
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; CSMT
at 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; 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).
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.
Background 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. However, no randomised controlled clinical trial (RCT) has compared
all the currently existing preventive interventions and no study has been
conducted to investigate whether combining different preventive strategies has
an additional effect. Therefore, we 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). The outcomes of this RCT will be of benefit to
all ESCRS members and cataract surgeons.
Study objective
The objective of this study is to evaluate the effect of different preventive
strategies on the occurrence of macular edema after cataract surgery in
non-diabetic and diabetic patients.
Study design
The design of the study is a multicentre randomised controlled clinical trial
with a duration of 54 months.
Intervention
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 disodium phosphate 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 disodium phosphate 0.1% in the
aforementioned dose;
- Topical bromfenac 0.09% and dexamethasone disodium phosphate 0.1% in the
aforementioned dose and a subconjunctival injection of 40 mg triamcinolone
acetonide (Triesence/Vistrec);
- Topical bromfenac 0.09% and dexamethasone disodium phosphate 0.1% in the
aforementioned dose and an intravitreal injection of 1.25 mg bevacizumab
(Avastin);
- Topical bromfenac 0.09% and dexamethasone disodium phosphate 0.1% in the
aforementioned dose, a subconjunctival injection of 40 mg triamcinolone
acetonide and an intravitreal injection of 1.25 mg bevacizumab.
Study burden and risks
In this study, standard phacoemulsification techniques will be used. Most
measurements and examinations are part of the regular medical treatment of
patients who need cataract surgery. Only OCT measurements are not part of the
standard of care in all patients. The examinations are non invasive, cause no
side-effects and only take a few minutes to perform. Patients will also be
asked to fill out questionnaires about their quality of vision and quality of
life twice.
The follow-up of standard cataract surgery includes 2 postoperative visits,
which is equal to our follow-up. However, the last study visit is planned after
the regular follow-up visits. Enrolled patients in Dutch study centres will
receive a gift voucher of ¤25,- as reimbursements for travel costs and
prescription costs.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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.
Exclusion criteria
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:
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 during the course of the study, 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 corticosteroids injection in the previous 4 months;
16. current use of topical NSAIDs or corticosteroids;
17. use of systemic corticosteroids (at least 20mg 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.;Diabetic patients will be excluded in case of:
1. macular edema with a CSMT *450 µm;
2. very severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004873-14-NL |
| ClinicalTrials.gov | NCT01774474 |
| CCMO | NL42463.068.12 |