macular edema after cataract surgery
Conditions
Interventions
All patients will receive phacoemulsification surgery for cataract and
placement of a posterior chamber intraocular lens (IOL). All patients in every
group will receive an intracameral cefuroxime in
[group 3:] intracameral injection of ketorolac tromethamine solution (Omidria
0.023 mg/mL) during cataract surgery.
[group 4:] subconjunctival injection of 10 mg TA and intracameral injection of
ketorolac tromethamine solution (Omidria
0.023 mg/mL) during cataract surgery.
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients: who are undergoing routine phacoemulsification; who are 21 years or older; who should be able to communicate properly and understand instructions.
Exclusion criteria
Exclusion criteria: All ophthalmic exclusion criteria are applicable to the study eye only, unless stated otherwise. General exclusion criteria for participation in this study are: patients who already participated with their contralateral eye; combined surgery (e.g. combined phacoemulsification and trabeculectomy); patients with an increased risk of developing cystoid macular edema (CME) in the study eye (e.g. diabetes mellitus, Fuchs' endothelial dystrophy, previous retinal venous occlusion, or a history of uveitis, macular edema, epiretinal membrane, or previous retinal surgery); patients who developed CME after cataract surgery in the contralateral eye; patients with cystoid macular changes in the study eye at baseline; patients with an increased risk of developing perioperative complications; patients with permanent moderate visual impairment in the contralateral eye (decimal visual acuity less than 0.3); patients with a history of steroid induced IOP rise or glaucomatous visual field loss; patients using drugs that reduce or increase the risk of macular edema (e.g., perioculair or intraocular corticosteroid, NSAID, or antivascular endothelial growth factor (VEGF) injection; topical corticosteroid or NSAID use; systemic corticosteroids (>= 20mg prednisolon), methotrexate, biologicals, or acetazolamide), or in the previous 4 months; patients with a contraindication for any of the investigated drugs; patients who are cardiovascular unstable; patients who have a history of hyperthyroidism. Data of subjects without a baseline OCT of sufficient quality will be excluded from analysis. However, these patients cannot be excluded from the study, as they already received (part of) the study medication. In case of perioperative complications (e.g. posterior capsule rupture, anterior vitrectomy, choroidal haemorrhage) data will not be included in the final analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in central subfield mean macular thickness (CSMT) at 6 weeks postoperative as compared to the baseline preoperative. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secundary endpoints are: the incidence of CME; the incidence of clinically significant macular edema (CSME); mean corrected distance visual acuity (CDVA); para- and perifoveal thickness and total macular volume (TMV); intraocular pressure (IOP); anterior chamber inflammation; visionrelated quality of life; cost-effectiveness. | — |
Countries
Netherlands
Outcome results
None listed