NL-OMON24763暂停不适用
rt-PA administration by retinal branch vein route for Central Retinal Vein Occlusion (CRVO). A Randomized - Conventional Therapy controlled – Trial.
Oogziekenhuis RotterdamSchiedamsevest 1803011 BH Rotterdam0 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 48
研究概览
简要总结
van Overdam KA, Missotten T, Spielberg LH. Updated cannulation technique for tissue plasminogen activator injection into peripapillary retinal vein for central retinal vein occlusion. Acta Ophthalmol. 2015; 93(8): 739-744.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Informed consent;
- •2. >18 years of age;
- •3. Adequate birth control (if not post-menopausal or sterilised) during a 2 week pre- and 6 week post-op period if assigned to vitreoretinal surgery;
- •4. Subjective decrease in visual acuity starting within 4 weeks prior to study start, due to CRVO, clinically evident by fundoscopy;
- •5. Non-perfused or perfused CRVO with a visual acuity of less than 20/200.
- •Note : Pseudophakic patients are allowed to participate in this study.
排除标准
- •1. Inability to visualize fundus due to corneal or important lenticular opacities;
- •2. Inability to obtain photographs of CRVO due to allergy to fluorescein or lack of veinous access;
- •3. As visual acuity prognosis is better and risk for neovascularisation is reduced in perfused CRVO, patients with a visual acuity > 20/200 will not be included;
- •4. Presence of iris neovascularisation (> grade 1) or anterior chamber angle (>grade 1) at the moment of presentation;
- •5. Other retinal or ophthalmic disorders that could influence the macular area;
- •6. Disorders that could be complicated by iris or retinal neovascularisation;
- •7. Disorders that could be complicated by any form of secondary glaucoma;
- •8. Prescription of acetazolamide or high dose systemic steroid (> 10 mg prednisone daily) or other anti-inflammatory medication (eg. MTX, Imuran, Endoxan, Humira, Kineret, Infliximab, Thalidomide) except NSAIDs;
- •9. Participation in another clinical ophthalmic trial;
- •10. Any surgery of the orbit, ocular adnexae or eye scheduled during the period the study (except for cataract surgery, developed after inclusion to a degree as outlined by the protocol);
- •11. Monophthalmia or other known ophthalmic disorder in the fellow eye that could be complicated by blindness;
- •12. Previous retinal surgery;
- •13. High myopia (-8 D spherical equivalent or more);
- •14. Macula affecting drugs.
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