Safety and efficacy of travoprost intracameral implant administered in combination with cataract surgery.

IF 2.3 Q2 OPHTHALMOLOGY
Therapeutic Advances in Ophthalmology Pub Date : 2025-02-14 eCollection Date: 2025-01-01 DOI:10.1177/25158414241310275
Inder Paul Singh, Lilit A Voskanyan, Kevin M Barber, James H Burden, LeAnne Connolly, L Jay Katz, Dale W Usner, Angela C Kothe, Tomas Navratil
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Abstract

Background: The travoprost intracameral implant and cataract surgery both lower intraocular pressure (IOP).

Objectives: We evaluated the safety and IOP-lowering effect at 3 months following administration of travoprost intracameral implant in combination with cataract surgery.

Design: Prospective, 12-month, open-label, single-arm trial.

Methods: We enrolled patients with age-related cataracts and open-angle glaucoma or ocular hypertension in the same eye. At baseline, patients were required to have an unmedicated mean diurnal IOP (average of 8:00 am, 10:00 am, and 4:00 pm IOPs) of 24 mmHg or greater, and an IOP of 36 mmHg or less at each of these three timepoints. On the day of the combined procedure (day 1), patients who had uncomplicated phacoemulsification cataract surgery received a travoprost intracameral implant. Follow-up evaluations occurred on day 2-3, week 2, week 6, and month 3 visits.

Results: Sixty patients had uncomplicated cataract surgery and received a travoprost intracameral implant. There were no serious adverse events. Study eye adverse events were reported in 8.3% of patients. The most frequently reported adverse event was dry eye (6.7%). At month 3, the mean diurnal IOP change from baseline was -10.6 mmHg (95% confidence interval: -11.2, -9.9; p < 0.0001) from an unmedicated baseline mean diurnal IOP of 25.2 mmHg. In addition, at month 3, 97% of eyes had a 20% or greater mean diurnal IOP reduction from baseline, and 91.0% of eyes had a mean diurnal IOP of 18 mmHg or less.

Conclusion: Administration of a travoprost intracameral implant combined with routine cataract surgery was safe. The sizable -10.6 mmHg IOP change from baseline at month 3 was both statistically significant and clinically relevant.

Trial registration: NCT06061718, Travoprost Intraocular Implant in Conjunction with Cataract Surgery, https://clinicaltrials.gov/study/NCT06061718.

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曲伏前列素内窥镜植入联合白内障手术的安全性和有效性。
背景:曲伏前列素内窥镜植入和白内障手术均可降低眼压。目的:评价曲伏前列素镜框内植入联合白内障手术后3个月的安全性和降低眼压的效果。设计:前瞻性,12个月,开放标签,单臂试验。方法:研究对象为同眼年龄相关性白内障合并开角型青光眼或高眼压患者。在基线时,要求患者在未用药的情况下平均每日IOP(上午8:00,上午10:00和下午4:00的平均IOP)为24 mmHg或更高,在这三个时间点的IOP均为36 mmHg或更低。在联合手术当天(第1天),接受无并发症白内障超声乳化手术的患者接受曲伏前列素镜框内植入。随访时间分别为第2-3天、第2周、第6周和第3个月。结果:60例患者均行无并发症白内障手术并行曲伏前列素镜框内植入。无严重不良事件发生。8.3%的患者报告了眼部不良事件。最常见的不良反应是干眼症(6.7%)。在第3个月,IOP与基线的平均日变化为-10.6 mmHg(95%可信区间:-11.2,-9.9;结论:行曲伏前列素内窥镜植入联合常规白内障手术是安全的。与基线相比,第3个月时眼压显著下降10.6 mmHg,这不仅具有统计学意义,而且具有临床相关性。试验注册:NCT06061718,曲伏前列素眼内植入联合白内障手术,https://clinicaltrials.gov/study/NCT06061718。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.50
自引率
0.00%
发文量
44
审稿时长
12 weeks
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