TY - JOUR
T1 - One-year results of a multicenter controlled clinical trial of triamcinolone in pars plana vitrectomy
AU - Yamakiri, Keita
AU - Sakamoto, Taiji
AU - Noda, Yoshihiro
AU - Nakahara, Masaaki
AU - Ogino, Nobuchika
AU - Kubota, Toshiaki
AU - Yokoyama, Mitsunobu
AU - Furukawa, Mariko
AU - Ishibashi, Tatsuro
N1 - Funding Information:
Acknowledgements This study was supported, in part, by a Grant-in-Aid from the Ministry of Education, Science and Culture, Japan. The authors indicate no financial conflict of interest.
PY - 2008/7
Y1 - 2008/7
N2 - Purpose: To evaluate the 1-year results of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV). Design: Multicenter prospective controlled clinical trial. Methods setting and study population: 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. Intervention: intra-operative use of TA to aid visualization of the vitreous. Main outcome measures: 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.
AB - Purpose: To evaluate the 1-year results of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV). Design: Multicenter prospective controlled clinical trial. Methods setting and study population: 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. Intervention: intra-operative use of TA to aid visualization of the vitreous. Main outcome measures: 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.
UR - http://www.scopus.com/inward/record.url?scp=44649202664&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=44649202664&partnerID=8YFLogxK
U2 - 10.1007/s00417-008-0829-0
DO - 10.1007/s00417-008-0829-0
M3 - Article
C2 - 18431588
AN - SCOPUS:44649202664
VL - 246
SP - 959
EP - 966
JO - Albrecht von Graefes Archiv für Klinische und Experimentelle Ophthalmologie
JF - Albrecht von Graefes Archiv für Klinische und Experimentelle Ophthalmologie
SN - 0065-6100
IS - 7
ER -