Abstract
Purpose
To compare surgical outcomes between patients who underwent Baerveldt glaucoma implantation versus trabeculectomy (TLE) for the treatment of neovascular glaucoma.
Methods
We performed a prospective, randomized, controlled clinical trial at Hiroshima University and Tsukazaki Hospital, Japan. Patients were randomized to Baerveldt glaucoma implantation (23 patients) or TLE (27 patients). The primary outcome measure was the rate of intraocular-pressure control. Secondary outcome measures included complications and interventions. We defined “failure” as intraocular pressure ≥ 22 mmHg or < 20% reduction from baseline pressure, on two consecutive follow-up visits; need for additional glaucoma surgery; vision-threatening complications; or loss of light perception. Kaplan–Meier analysis was used to determine surgical success rates. Postoperative complications and interventions were compared between the two groups with Pearson Chi-square tests.
Results
There were no significant differences in demographic or ocular characteristics between the treatment groups at baseline. The postoperative follow-up was 26.6 ± 19.4 months in the Baerveldt group and 27.3 ± 20.1 months in the TLE group. There were no statistical differences (Mann–Whitney nonparametric tests with Bonferroni correction) in postoperative intraocular pressure measured at 6-month intervals. Success rates were 59.1 and 61.6% at 1-year after Baerveldt glaucoma implantation and TLE, respectively. Kaplan–Meier analysis showed no significant difference in success between groups (P = 0.71, log-rank test). Medication use, visual acuity, and interventions were similar between groups. Thirteen late postoperative complications developed in the Baerveldt glaucoma implantation group and four complications developed in the TLE group. Tube exposure was the most common late complication.
Conclusion
These two procedures produced similar surgical success, intraocular-pressure reductions, visual acuity, and number of medications at the last visit. The TLE group showed smaller numbers of late complications and patients who lost more than two lines of visual acuity. Therefore, TLE might be a safer and better way to treat patients with neovascular glaucoma.
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Availability of data and material
The data that support the findings of this study are available from the corresponding author, Kana Tokumo, upon reasonable request.
Code availability
Statistical analysis was conducted using JMP version-13 statistical software (SAS Institute Inc., Cary, NC, USA).
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We thank Claire Barnes, PhD, from Edanz Group (https://en-author-services.edanz.com/ac) for editing a draft of this manuscript.
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All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Kana Tokumo, and Shunsuke Nakakura. The first draft of the manuscript was written by Kana Tokumo. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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The Institutional Review Board of Hiroshima University Hospital and Saneikai Tsukazaki Hospital approved the study protocol before recruitment began. This study was registered with the University Hospital Medical Information Network Clinical Trials Registry of Japan (identifier University Hospital Medical Information Network 000008980; date of access and registration, September 25, 2012). The tenets of the Declaration of Helsinki were followed.
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Written informed consent was obtained from all the patients before the surgical procedure.
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Tokumo, K., Komatsu, K., Yuasa, Y. et al. Treatment outcomes in the neovascular glaucoma tube versus trabeculectomy study. Graefes Arch Clin Exp Ophthalmol 259, 3067–3076 (2021). https://doi.org/10.1007/s00417-021-05257-2
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DOI: https://doi.org/10.1007/s00417-021-05257-2