Prevention of macular edema after cataract surgery

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1135

Inclusion Criteria

All patients undergoing routine phakoemulsification.
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

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 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
antiglaucomatous medication or steroid-induced IOP elevation that
required IOP-lowering treatmeht
8. IOP > or = 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. hiatory of retinal vein occlusion
13. any macular pathology that might affect visual acuity, other than
diabetic macular edema
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 (> or = 20 mg prednisolone or
equivalence)
18. history of relevant adverse events, including serious adverse events
(SAE), occuring after administration of NSAIDs, acitylsalicylic acid,
sodium sulphite, corticosteroids or bevacizumab
19. contraindications for use of topical 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 > or = 450 µm
2. very severe NPDR or proliferative DR requiring panretinal
photocoagulation or vitrectomy
3. vitreous hemorrhage present during preoperative visit(s)
4. cerebrovascular incident, myocardial infarction 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary endpoint is the occurence of postoperative clinically significant macular edema (CSME) within 12 weeks postoperatively.<br><br>Other study endpoints are:<br>mean CDVA in logMAR at 6 and 12 weeks postoperatively;<br>CSMT 12 weeks postoperatively;<br>OCT measured average retinal thickness in the inner circle (3mm), the outer circle (6mm), and the macular volume at 6 and 12 weeks postoperatively;<br>intraocular pressure at 6 and 12 weeks postoperatively;;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;Main Objective: The primary endpoint of of the study is the Change in central subfield mean macular thickness (CSMT) as compared to baseline at 6 weeks postoperatively.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The occurrence of postoperative clinically significant macular edema within 12 weeks postoperative;<br>Best corrected visual acuity (BCVA);<br>Intraocular pressure (IOP);<br>Adverse events;Timepoint(s) of evaluation of this end point: Preoperative and 6 and 12 weeks postoperative