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A pilot study of intraocular use of intensive anti-inflammatory- triamcinolone acetonide to prevent proliferative vitreoretinopathy in eyes undergoing vitreoretinal surgery for open globe trauma- the adjuncts in ocular trauma (AOT) trial

Session Details

Session Title: Vitreo Retinal Surgery I

Session Date/Time: Thursday 11/09/2014 | 08:00-10:00

Paper Time: 08:24

Venue: Auditorium

First Author: : P.Banerjee UK

Co Author(s): :    W. Xing   C. Bunce   A. Chandra   D. Charteris     

Abstract Details

Purpose:

Eyes sustaining open globe trauma (OGT) are at high risk of severe visual impairment. Proliferative vitreoretinopathy (PVR) is the commonest cause of retinal redetachment in these eyes and occurs in up to 45% of cases. Intensive anti-inflammtory agents have proven effective at modifying experimental PVR and are well tolerated clinically. The Adjuncts in Ocular Trauma (AOT) Trial investigated the effect of using intensive anti-inflammatory agents (intravitreal and subtenons Triamcinolone acetonide, oral flurbiprofen and guttae prednisolone acetate 1%) peri-operatively in patients undergoing vitrectomy surgery following OGT.

Setting:

A two year, pilot, single-centre prospective, participant and surgeon-masked randomized-controlled-clinical trial (EudraCT No 2007/005138/35)

Methods:

Forty patients requiring vitrectomy surgery following OGT were randomized to either standard or study treatment in a 1:1 allocation ratio, with care differing only in the addition of supplementary adjunctive agents in the adjunct group. Primary outcome measure was anatomical success at 6 months in the absence of internal tamponade. Secondary outcomes included final visual acuity, occurrence of PVR, IOP rise, number of operations and recruitment rate

Results:

All 40 patients were recruited within 21 months of study commencement; 39 patients had outcome data. Primary outcome assessment showed no difference in anatomical success between the two groups. Anatomical success was 50 % (10/20) in the adjunct group, compared to 47% (9/19) in the standard group (Odds Ratio 0.90, 95%Confidence Interval 0.256-3.162). Visual outcomes showed a trend towards a positive treatment effect, with a final median visual acuity of 31 ETDRS letters in the adjunct group, compared to 25 ETDRS letters in the standard group. A higher proportion of patients gained 10, 20 and 30 ETDRS letters in the adjunct group (80%, 65% and 50%, respectively) compared to the standard group (52.6%, 52.6% and 42.1%). Fewer patients had poor visual outcomes (Zero ETDRS letters) in the adjunct group (15%, n=3) compared to the standard group (42.1%, n=8). Postoperative PVR incidence was higher in the standard group at all time-points. No difference in the number of operations to achieve anatomical success was observed.

Conclusions:

An RCT in this population is deliverable and estimated recruitment rates are realistic. Intensive anti-inflammatory agents may be a useful adjunct in this disease group and an adequately powered randomised control trial is justified

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