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Comparison of Nepafenac 0.1% plus steroid - dexamethasone 0.1% versus steroid alone for cataract surgery - randomized, double masked, prospective trial

Session Details

Session Title: Cystoid Macular Oedema and Infection

Session Date/Time: Sunday 06/10/2013 | 16:30-18:00

Paper Time: 16:42

Venue: Forum (Ground Floor)

First Author: : A.Zaczek SWEDEN

Co Author(s): :    D. Artzen   C. Laurell   U. Stenevi   P. Montan     

Abstract Details

Purpose:

To evaluate the efficacy of added pre- and postoperatively 0, 1 % nepafenac ophthalmic suspension to 0.1% dexamethasone in controlling postoperative inflammation, pain and degree of macular swelling after cataract surgery.

Setting:

1. Ophthalmology Department, Sahlgrenska University Hospital, Mölndal, Sweden 2. St Erik Eye Hospital/KI, Stockholm, Sweden

Methods:

One-hundred-fifty two patients, 75 eyes in the nepafenac group and 77 eyes in the placebo group, were enrolled in this randomized, double masked prospective, multicentrial study. The Total Macula Volume (TMV) were measured by OCT preoperatively, 3 and 6 weeks postoperatively. The best-corrected visual acuity (BCVA), pain sensation and laser flare intensity in the anterior chamber were also recorded.

Results:

There were not statistically significant differences concerning age, gender, type and hardness of cataract and phacoemulsification time (P< .005) between groups. Mean laser flare intensity 1 day after surgery was statistically significantly lower in the nepafenac group 17.9 (3.3-40.3) than in the placebo group 40.5 (1.1-1056) (P= .0285). During 24 hours after operation, 58.7 % of patients in the nepafenac group had no pain after operation and only 22.1% patients were pain-free in the placebo group (P< .0001). The nepafenac group had significantly less increased of TMV from baseline with mean value: 0.179 (-0.430-1.080) compared to the placebo group: 0.329 (-0.480-1.080), 6 weeks after surgery, (P= .0002). In the placebo group, two patients developed cystoid macular edema (CME) (2.6%) at 3 weeks postoperatively. No significant differences were found in BCVA between the two study groups 6 weeks after operation (P=0.73).

Conclusions:

Pre-op add-on nepafenac with postoperative combination therapy with steroids significantly decreased inflammation, pain and subclinical macula edema after uncomplicated cataract surgery compared to steroids treatment alone. The combination treatment may be a valid option for prophylactic treatment of CME after cataract surgery.

Financial Interest:

NONE