Diakonis Vasilios F, Kymionis George D, Tsaousis Konstantinos T, Bondurant Renee C, Watson Caroline C, Koulotsiou Konstantina G, Weinstock Robert J
The Eye Institute of West Florida, 1225 West Bay Drive East Largo, Largo, FL, 33770, USA.
Ophthalmology Department, National and Kapodistrian University of Athens, Athens, Greece.
Adv Ther. 2025 Aug 13. doi: 10.1007/s12325-025-03306-4.
This study aimed to compare the safety and efficacy of intracameral dexamethasone 9% single-dose sustained-release suspension with the established pharmaceutical regimen after cataract surgery.
This prospective self-controlled study included consecutive patients with bilateral visually significant cataracts. Patients received bilateral cataract extraction in the Eye Institute of West Florida by the same experienced surgeon (RJW). One randomly selected eye of every patient received a sustained-release dexamethasone 9% suspension placed in the capsular bag at the optic-haptic junction of the intraocular lens (study group); post-cataract topical regimen included topical antibiotic and NSAID. The other eye (control group) received only topical pharmaceutical agents after cataract extraction, which included the same antibiotic and NSAID as the fellow eye along with a steroid. All patients were followed at day 1, 7, and 30 after cataract surgery and visual acuity, manifest refraction, subjective anterior chamber inflammation grading, subjective patient pain score (questionnaire) along with specular microscopy of the cornea and optical coherence tomography of the macula were evaluated.
Forty-eight eyes of 24 patients (16 female and 8 male), aged 69.54 ± 7.36 (range 54-85 years), were included in the study. All patients completed the follow-up, while none of the study eyes required additional topical treatment for inflammation control. Anterior chamber inflammation, assessed using the Summed Ocular Inflammation Score (SOIS), demonstrated a mild inflammatory response postoperatively, which resolved over time in both groups. On postoperative day 1, SOIS was slightly higher in the study eyes (1.12 ± 0.23) compared to the control eyes (0.92 ± 0.34, p = 0.054). By day 7, inflammation had significantly decreased (study: 0.16 ± 0.23; control: 0.17 ± 0.20, p = 0.88), with no residual inflammation at the final follow-up. Uncorrected and corrected distance visual acuity, intraocular pressure, anterior chamber inflammation, corneal endothelial cell density, and central retinal thickness demonstrated no significant difference between the study and control group throughout the follow-up (p > 0.05). None of the patients reported pain after either procedure, while no intra- or postoperative complications were noted in any of the eyes.
The use of intracameral dexamethasone 9% sustained-release suspension placed in the capsular bag at the time of cataract surgery seems to offer similar safety and efficacy as the established post-cataract topical regimen. Furthermore, no signs of iris atrophy were evident in any of the eyes up to 1 month post cataract surgery.
本研究旨在比较白内障手术后前房内注射9%地塞米松单剂量缓释混悬液与既定药物治疗方案的安全性和有效性。
这项前瞻性自我对照研究纳入了连续的双眼患有明显视力障碍性白内障的患者。患者在西佛罗里达眼科学院由同一位经验丰富的外科医生（RJW）进行双侧白内障摘除术。每位患者随机选择一只眼，在人工晶状体的光学部与袢的交界处的囊袋内注入9%地塞米松缓释混悬液（研究组）；白内障术后局部用药方案包括局部抗生素和非甾体抗炎药。另一只眼（对照组）在白内障摘除术后仅接受局部药物治疗，包括与对侧眼相同的抗生素和非甾体抗炎药以及一种类固醇。所有患者在白内障手术后第1天、第7天和第30天进行随访，评估视力、显验光、主观前房炎症分级、患者主观疼痛评分（问卷）以及角膜内皮镜检查和黄斑光学相干断层扫描。
本研究纳入了24例患者（16例女性和8例男性）的48只眼，年龄为69.54±7.36岁（范围54 - 85岁）。所有患者均完成随访，研究组中没有一只眼需要额外的局部治疗来控制炎症。使用眼部炎症总分（SOIS）评估的前房炎症显示术后有轻度炎症反应，两组炎症均随时间消退。术后第1天，研究组的SOIS（1.12±0.23）略高于对照组（0.92±0.34，p = 0.054）。到第7天，炎症明显减轻（研究组：0.16±0.23；对照组：0.17±0.20，p = 0.88），最终随访时无残留炎症。在整个随访过程中，研究组和对照组的未矫正和矫正远视力、眼压、前房炎症、角膜内皮细胞密度和中心视网膜厚度均无显著差异（p>0.05）。两组手术均无患者报告疼痛，所有眼中均未观察到术中或术后并发症。
白内障手术时在囊袋内注入9%地塞米松缓释混悬液似乎与既定的白内障术后局部用药方案具有相似的安全性和有效性。此外，在白内障手术后长达1个月的时间里，所有眼中均未出现虹膜萎缩的迹象。
