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Effect modification of the prevention of cystoid macular edema after cataract surgery: a report from the ESCRS PREMED study

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First Author: C.Veldhuizen THE NETHERLANDS

Co Author(s):    B. Winkens   L. Wielders   F. van den Biggelaar   J. Schouten   R. Simons   R. Nuijts     

Abstract Details

Purpose:

To identify effect-modifiers of known pharmacological strategies for the prevention of cystoid macular edema (CME) after uncomplicated cataract surgery, in patients without diabetes mellitus

Setting:

The setting was a multicenter randomized clinical trial at twelve European study centers: the European Society of Cataract and Refractive Surgeons (ESCRS) PREvention of Macular EDema after cataract surgery (PREMED) study.

Methods:

Patients were randomized to one of three groups: the first received topical bromfenac 0.09% 2x daily for two weeks, the second received dexamethasone 0.1% 4x daily, following a weekly tapering scheme. The third received a combination of these medications. Outcomes included: central subfield mean thickness (CSMT), corrected distance visual acuity, CME incidence. Potential effect-modifiers of these preventive strategies were initially tested as three-way interaction terms, including treatment-randomization and timing (6, 12 weeks postoperatively). Where overall interaction-term tests proved significant, restricted-maximum-likelihood linear mixed models were applied, to assess treatment-effects for each effect-modifier category. Investigated potential effect-modifiers included: gender, hypertension, smoking, hypercholesterolemia.

Results:

For smokers, 2 lines LogMAR visual acuity improvement was found for the groups treated with the combination of topical dexamethasone and bromfenac, as compared to those treated with bromfenac alone (6 weeks P=0.002, 12 weeks P=0.003). For patients with hypercholesterolemia, analysis showed significant lowering of CSMT, for the group treated with the combination vs. those treated with dexamethasone alone (6 weeks P less than 0.001). This study did not show any significant effect-modification of gender or hypertension.

Conclusions:

Smoking appears to exert effect-modification on preventive treatment with the combination of both dexamethasone and bromfenac topically vs. bromfenac alone. This can be interpreted as a potential additional visual benefit for smokers treated with the combination approach, as compared to monotherapy with topical bromfenac. Additionally, 6 weeks postoperatively, nondiabetic patients with hypercholesterolemia appeared to have greater benefits from the inclusion of topical bromfenac in their prophylactic protocol.

Financial Disclosure:

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