Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada; Prism Eye Institute, Mississauga, Canada.
Department of Ophthalmology, Queen's University, Kingston, Canada.
Ophthalmol Glaucoma. 2022 Jan-Feb;5(1):67-76. doi: 10.1016/j.ogla.2021.05.009. Epub 2021 Jun 4.
To compare the efficacy and safety of early versus later ab interno gelatin microstent placement with mitomycin C.
Canada-wide, multicenter, retrospective propensity score-matched cohort study.
Two hundred seventy eyes (135 early cases and 135 later cases) with no prior incisional surgery.
Surgeons' first 20 patients (early cases group), from 6 glaucoma surgeons across 4 Canadian sites, were matched 1:1 to patients with the closest propensity score from the later (21+) patients (later cases group).
Primary outcome was hazard ratio (HR) of failure of the early versus later cases groups, with failure defined as IOP of less than 6 mmHg with more than 2 lines of vision loss or more than 17 mmHg with no medications (complete success) on 2 consecutive visits despite in-clinic maneuvers (including needling) more than 1 month after surgery. Secondary outcomes were HRs for failure, defined as IOP outside the range of 6 to 14 mmHg and 6 to 21 mmHg with and without allowing for medications (qualified success), interventions, complications, and reoperations.
Hazard ratio of failure for early versus later cases groups was 1.38 (95% confidence interval [CI], 0.97-1.96) for the IOP range of 6 to 17 mmHg, 1.29 (95% CI, 0.90-1.84) for 6 to 14 mmHg, and 1.48 (95% CI, 1.03-2.13) for 6 to 21 mmHg without medication and 0.95 (95% CI, 0.55-1.64), 0.95 (95% CI, 0.61-1.48), and 0.95 (95% CI, 0.52-1.75) for the same IOP ranges allowing for medications. Needling rates were 43.0% (early cases group) and 41.5% (later cases group). Complication rates after 1 month occurred in 9.6% (early cases group) and 11.1% (later cases group; P = 0.69). Reoperation rates were 14.8% (early cases group) and 8.1% (later cases group; P = 0.08).
There is some evidence for improved success in the later cases group. Similar needling rates, similar complication rates, and a slightly higher reoperation rate were found for the early cases group. The results suggest that this procedure can be adopted by existing surgeons with current training regimens, although they may see an improvement in their success outcomes over time.
比较早期与晚期行内源性玻璃体内明胶微支架植入联合丝裂霉素 C 的疗效和安全性。
加拿大范围内的多中心回顾性倾向评分匹配队列研究。
270 只眼（135 例早期病例和 135 例晚期病例），均无初次手术史。
6 位青光眼外科医生在 4 个加拿大地点的前 20 例患者（早期病例组），按照最近的倾向评分与随后（21+）的患者（晚期病例组）进行 1:1 匹配。
主要结局是早期与晚期病例组之间失败的风险比（HR），失败定义为术后 1 个月以上行门诊操作（包括针刺）后，2 次连续就诊时眼压仍<6mmHg 且视力下降>2 行或>17mmHg 且未使用药物（完全成功），同时排除 617mmHg、614mmHg 和 621mmHg 范围内允许药物使用时的成功情况（有条件成功）。次要结局是 617mmHg、614mmHg 和 621mmHg 范围内排除药物使用时失败的 HR，以及干预、并发症和再次手术的 HR。
617mmHg 范围内早期与晚期病例组之间失败的 HR 为 1.38（95%置信区间[CI]，0.971.96），614mmHg 范围内为 1.29（95% CI，0.901.84），621mmHg 范围内为 1.48（95% CI，1.032.13），且排除药物使用时，0.95（95% CI，0.551.64）、0.95（95% CI，0.611.48）和 0.95（95% CI，0.52~1.75）。针刺率分别为 43.0%（早期病例组）和 41.5%（晚期病例组）。术后 1 个月时的并发症发生率分别为 9.6%（早期病例组）和 11.1%（晚期病例组；P=0.69）。再手术率分别为 14.8%（早期病例组）和 8.1%（晚期病例组；P=0.08）。
晚期病例组的成功率略有提高。早期病例组的针刺率、并发症发生率相似，再手术率略高。结果表明，在现有训练方案下，现有外科医生可以采用该手术方法，尽管随着时间的推移，他们的成功率可能会有所提高。
