Bilgic Alper, Sudhalkar Aditya, Kodjikian Laurent, Vasavada Viraj, Vasavada Shail, Bhojwani Deepak, Vasavada Vaishali, Srivastava Samaresh
Alpha Vision Augenzentrum, Bremerhaven, Germany.
Alpha Vision Augenzentrum, Bremerhaven, Germany; Sudhalkar Eye Hospital and Retina Centre, Baroda, India; Raghudeep Eye Hospital, Ahmedabad, India.
Ophthalmol Retina. 2019 Nov;3(11):929-937. doi: 10.1016/j.oret.2019.05.027. Epub 2019 Jun 3.
To determine the utility and safety of the intravitreal dexamethasone implant as primary therapy (pro re nata [PRN]) in phakic eyes with early treatment-naive diabetic macular edema (DME).
Prospective, case series.
Patients with diabetes mellitus whose eyes were phakic and had early treatment-naive clinically significant macular edema.
Patients whose eyes were phakic with DME (<3 months) were included if the central subfield thickness (CST) was >300 μm and corrected distance visual acuity (CDVA) between 0.3 and 1.0 logarithm of minimum angle of resolution. A comprehensive ocular and systemic examination was performed and the implant injected PRN using a standardized technique. Patients had follow-up at least monthly for 2 years. Descriptive statistics were used to analyze categorical variables in terms of size and proportions. The repeated-measures analysis of variance test was used to determine the change in CDVA, CST, intraocular pressure, and hard exudate area over time.
The primary outcome measure was the determination of the change in CDVA at month 24 from baseline. Secondary outcome measures included determining the change in CST, median number of injections, proportion gaining 15 letters, and complications, if any.
A total of 153 patients (85 males) were included. At 2 years, mean CDVA improved from 0.62 to 0.4 logarithm of minimum angle of resolution, and median CST improved from 397 to 236 μm. The median number of injections was 1.6. Cataract developed in 3 patients with a clear lens, and 31 patients required topical antiglaucoma therapy. Proliferative disease developed in 4 patients, which was managed with panretinal photocoagulation. None of the study patients required rescue therapy.
In patients with treatment-naive phakic eyes who had DME, primary therapy with the intravitreal dexamethasone implant PRN (for 2 years) resulted in significantly improved mean CDVA. A fifth of the patients required control of intraocular pressure, and new-onset cataract developed in 3 of 153 patients.
确定玻璃体内地塞米松植入物作为初治（按需[PRN]）疗法用于早期未经治疗的有晶状体眼糖尿病性黄斑水肿（DME）的有效性和安全性。
前瞻性病例系列研究。
患有糖尿病且为有晶状体眼并患有早期未经治疗的具有临床意义的黄斑水肿的患者。
如果中心子野厚度（CST）>300μm且矫正远视力（CDVA）在0.3至1.0最小分辨角对数之间，则纳入患有DME（<3个月）的有晶状体眼患者。进行了全面的眼部和全身检查，并使用标准化技术按需注射植入物。患者至少随访2年。描述性统计用于分析分类变量的大小和比例。重复测量方差分析用于确定CDVA、CST、眼压和硬性渗出面积随时间的变化。
主要观察指标是确定第24个月时CDVA相对于基线的变化。次要观察指标包括确定CST的变化、注射次数中位数、视力提高15行的患者比例以及并发症（如有）。
共纳入153例患者（85例男性）。2年后，平均CDVA从0.62提高到0.4最小分辨角对数，CST中位数从397μm改善至236μm。注射次数中位数为1.6次。3例晶状体透明的患者发生了白内障，31例患者需要局部抗青光眼治疗。4例患者发生了增殖性病变，采用全视网膜光凝治疗。没有研究患者需要抢救治疗。
在患有未经治疗的有晶状体眼DME的患者中，玻璃体内地塞米松植入物按需（持续2年）进行初治可使平均CDVA显著改善。五分之一的患者需要控制眼压，153例患者中有3例出现了新发白内障。
