Clinical evaluation of the safety and efficacy of preservative-free triamcinolone (triesence [triamcinolone acetonide injectable suspension] 40 mg/ml) for visualization during pars plana vitrectomy.
OBJECTIVE
To evaluate the safety and efficacy of preservative-free triamcinolone (TRIESENCE(R) suspension) for visualization during pars plana vitrectomy.


METHODS
This phase III, observer-masked study was conducted in 6 centers by 10 surgeons and enrolled 60 patients undergoing pars plana vitrectomy. Preservative-free triamcinolone (up to 4 mg) was administered to all patients to enhance visualization of vitreous and membranes. During each surgery, video recordings captured visualization pre- and postinstillation of preservative-free triamcinolone. An independent, masked reader evaluated the videos for the degree of visualization using a five-point scale ranging from 0 (not visible) to 4 (clearly delineated). Surgeons used a five-point scale ranging from "strongly disagree" to "strongly agree" to assess whether preservative-free triamcinolone improved visualization.


RESULTS
In 59 of 60 cases, the masked reader's scores for visualization of posterior segment structures were higher (i.e., structures were more clearly visible) after instillation of preservative-free triamcinolone. The preinstillation mean visualization score was 0.5 compared to 3.7 postinstillation (P < 0.0001). Greater than 90% of surgeon evaluations agreed or strongly agreed that preservative-free triamcinolone enhanced visualization of posterior segment structures. No safety issues were identified.


CONCLUSIONS
Preservative-free triamcinolone (TRIESENCE(R) suspension) was well tolerated and effectively enhanced visualization of posterior segment structures during pars plana vitrectomy.
Dyer
David
D
Retina Associates P.A., Shawnee Mission, Kansas, USA.
Callanan
David
D
Bochow
Thomas
T
Abraham
Prema
P
Lambert
H Michael
HM
Lee
S Young
SY
Schneiderman
Todd
T
Potts
Susan L
SL
Walker
Thomas M
TM
D001485:Basement Membrane / Q000473:pathology*; D004311:Double-Blind Method; D005128:Eye Diseases / Q000601:surgery; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011310:Preservatives, Pharmaceutical; D012164:Retinal Diseases / Q000601:surgery; D013535:Suspensions; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000009:adverse effects; D014821:Vitrectomy; D014822:Vitreous Body / Q000473:pathology* / Q000601:surgery
D005938:Glucocorticoids; D011310:Preservatives, Pharmaceutical; D013535:Suspensions; D014222:Triamcinolone Acetonide