One-year results of a multicenter controlled clinical trial of triamcinolone in pars plana vitrectomy.
OBJECTIVE
To evaluate the 1-year results of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV).


METHODS
Multicenter prospective controlled clinical trial.


METHODS



METHODS
the study population comprised 774 eyes from patients treated at eight Japanese hospitals, among which 391 eyes underwent TA-assisted PPV and 383 control eyes underwent conventional PPV. The patients were assigned to the two groups using a single-blind quasi-randomization approach within the participating clinical centers.


METHODS
intra-operative use of TA to aid visualization of the vitreous.


METHODS
changes of visual acuity, post-operative complications (including additional surgery), and adverse events occurring within 1 year of the operation were compared between the TA-PPV group and the conventional PPV group.


RESULTS
The visual acuity improved over time, and no significant differences were found between the two groups (log-rank versus TA, P = 0.98 for improvement, P = 0.26 for deterioration). The logistic regression model also showed that the intra-operative use of TA was not a significant factor for the improvement of visual acuity [P = 0.91, odds ratio (OR) = 1.10, 95% confidence interval (95%CI) = 0.860-1.183)] after adjustments for age, gender, and diagnosis. Intra-operative TA was not a significant factor for the need for additional surgery (log-rank test P = 0.45, logistic regression test P = 0.35, OR = 1.23, 95%CI = 0.797-1.911]. No serious adverse events related to surgery were observed.


CONCLUSIONS
This 1-year follow-up study of a controlled clinical trial showed that TA-assisted PPV had neither a positive nor a negative effect on visual acuity, the incidence of additional surgeries, or adverse events compared with conventional PPV.
Yamakiri
Keita
K
Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Science, Sakuragaoka 8-35-1, Kagoshima 890-8520, Japan.
Sakamoto
Taiji
T
Noda
Yoshihiro
Y
Nakahara
Masaaki
M
Ogino
Nobuchika
N
Kubota
Toshiaki
T
Yokoyama
Mitsunobu
M
Furukawa
Mariko
M
Ishibashi
Tatsuro
T
D003930:Diabetic Retinopathy / Q000601:surgery; D005260:Female; D005938:Glucocorticoids; D006801:Humans; D007430:Intraoperative Care; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011446:Prospective Studies; D012163:Retinal Detachment / Q000601:surgery; D016037:Single-Blind Method; D014222:Triamcinolone Acetonide; D014792:Visual Acuity; D014821:Vitrectomy / Q000379:methods*; D018630:Vitreoretinopathy, Proliferative / Q000601:surgery; D014822:Vitreous Body / Q000473:pathology*
D005938:Glucocorticoids; D014222:Triamcinolone Acetonide