Purpose

To describe visual field (VF) outcomes in the Tube Versus Trabeculectomy (TVT) Study.

Design

Cohort analysis of patients in a multicenter randomized clinical trial.

Participants

A total of 122 eyes of 122 patients, with 61 eyes in both the tube shunt and trabeculectomy groups.

Methods

The TVT Study is a multicenter randomized clinical trial comparing the safety and efficacy of tube shunt surgery (350-mm² Baerveldt implant) and trabeculectomy with mitomycin C (MMC) (0.4 mg/ml for 4 minutes) in patients with previous cataract or glaucoma surgery. Enrolled patients underwent perimetry at baseline and annual follow-up visits. The VFs were included if the false-positive rate was ≤20% and false-negative rate was ≤35%. The VFs were excluded if visual acuity <20/400 or loss of ≥2 Snellen lines from baseline was attributed to an etiology other than glaucoma. Longitudinal linear mixed-effects models with best linear unbiased predictions (BLUPs) were applied to estimate rates of change in mean deviation (MD) for each treatment group.

Main Outcome Measure

Rate of MD change during follow-up period.

Results

A total of 436 reliable VFs were analyzed, with an average of 3.6 VFs per eye. Baseline MD was −13.07 ± 8.4 decibels (dB) in the tube shunt group and −13.18 ± 8.2 dB in the trabeculectomy group (P = 0.99). The rate of change in MD was −0.60 dB/year in the tube group and −0.38 dB/year in the trabeculectomy group (P = 0.34). The 95% confidence intervals for the rates of MD change were −0.77 to −0.44 dB/year in the tube group and −0.56 to −0.20 dB/year in the trabeculectomy group. No significant difference in MD slope was seen when patients were categorized by percentage of visits with intraocular pressure (IOP) <18 mmHg or by average IOP. Univariable and multivariable risk factor analyses identified history of diabetes, elevated IOP, and worse MD as baseline factors associated with more rapid VF loss.

Conclusions

Slow rates of VF loss were observed after randomized surgical treatment in the TVT Study, but no significant difference in the rate of VF loss was seen after tube shunt implantation and trabeculectomy with MMC. Patients with diabetes, higher IOP, and more severe VF loss at baseline were at higher risk for VF progression.

中文翻译：

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管与小梁切除术研究中的视野结果。

目的

描述管与小梁切除术 (TVT) 研究中的视野 (VF) 结果。

设计

多中心随机临床试验中患者的队列分析。

参与者

122例患者共122眼，管分流术组和小梁切除术组各61眼。

方法

TVT 研究是一项多中心随机临床试验，在既往白内障或青光眼患者中比较管分流术（350-mm ² Baerveldt 植入物）和丝裂霉素 C (MMC)（0.4 mg/ml，持续 4 分钟）小梁切除术的安全性和有效性手术。入组患者在基线和年度随访时接受视野检查。如果假阳性率≤20％和假阴性率≤35％，则包括VF。如果视敏度 <20/400 或从基线损失 ≥2 条 Snellen 线归因于青光眼以外的病因，则排除 VF。应用具有最佳线性无偏预测 (BLUP) 的纵向线性混合效应模型来估计每个治疗组的平均偏差 (MD) 变化率。

主要成果衡量标准

随访期间 MD 变化率。

结果

共分析了 436 个可靠的 VF，平均每只眼睛 3.6 个 VF。分流管组的基线 MD 为 -13.07 ± 8.4 分贝 (dB)，小梁切除术组的基线 MD 为 -13.18 ± 8.2 dB ( P = 0.99)。管组的 MD 变化率为 -0.60 dB/年，小梁切除术组为 -0.38 dB/年（P =0.34)。导管组 MD 变化率的 95% 置信区间为 -0.77 至 -0.44 dB/年，小梁切除术组为 -0.56 至 -0.20 dB/年。当患者按眼压 (IOP) <18 mmHg 的就诊百分比或平均 IOP 分类时，MD 斜率没有显着差异。单变量和多变量风险因素分析确定糖尿病史、眼压升高和 MD 恶化是与更快的 VF 丧失相关的基线因素。

结论

在 TVT 研究中，随机手术治疗后观察到 VF 丢失率缓慢，但在管分流器植入和 MMC 小梁切除术后，VF 丢失率没有显着差异。基线时患有糖尿病、眼压较高和更严重的 VF 丧失的患者发生 VF 进展的风险更高。