NCT03647267已完成3 期
Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction
Jaeb Center for Health Research81 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2018年10月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 81
- 主要终点
- Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy
研究概览
简要总结
Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection to determine if pneumatic vitreolysis (PVL) is effective in releasing VMT.
详细描述
Investigational Device: 0.3-mL intraocular gas (C3F8) injection
Objectives
Primary
- To compare the proportion of eyes with central VMT release on OCT after pneumatic vitreolysis with gas injection versus observation (sham injection) in eyes with VMT without an associated macular hole.
Secondary 2. To evaluate visual function outcomes at 24 weeks after gas injection is performed compared with sham injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Visual acuity and optical coherence tomography technicians will be masked to treatment group at all visits. The goal is for study participants to remain masked to their treatment group assignment, although it is likely that the gas bubble will be visible to participants in the pneumatic vitreolysis group. Investigators and study coordinators are not masked to treatment group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one eye meets the study eye criteria listed below.
- •Able and willing to provide informed consent.
- •Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks).
- •For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks).
- •Able and willing to wear wristband that informs any medical personnel that the patient has a gas bubble in the eye
- •A potential participant is not eligible if any of the following
排除标准
- •are present:
- •A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status that might preclude completion of follow-up)
- •Participation in an investigational trial within 30 days of randomization that involves treatment with any drug or device that has not received regulatory approval for the indication being studied at the time of study entry
- •Note: study participants should not receive another investigational drug/device while participating in the study
- •Known contraindication to any component of the treatment
- •Known allergy to any drug used in the procedure prep (including povidone iodine)
- •Potential participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 6 months following randomization
- •Anticipated surgery requiring anesthesia within the next 6 months following randomization
- •Participants cannot receive nitrous oxide until gas resolution
- •For women of child-bearing potential, pregnant at the time of enrollment
- •Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgement may be used to determine when a pregnancy test is needed.
- •Study Eye Criteria
- •The participant must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below.
- •A participant can have only one study eye. If both eyes are eligible at the time of randomization, the study eye will be selected by the investigator and participant before randomization.
- •The eligibility criteria for a study eye are as follows:
- •Vitreomacular adhesion on OCT that is no larger than 3000 microns with visible separation of the vitreous on either side as seen on horizontal and vertical scans, confirmed by central reading center Note: presence of epiretinal membrane is neither a requirement nor exclusion.
- •Decreased visual function (e.g. metamorphopsia or other visual symptom) that is attributed to VMT.
- •Examples of visual symptoms include:
- •a) Distortion and/or reduction in visual acuity b) Recognized difficulty with reading, driving, or using a computer c) Patient recognized interference with quality of life because of a and/or b.
- •c. Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or better) and at most 78 (20/32 or worse) d. Investigator and participant willing to wait 6 months before surgical intervention, provided visual acuity remains stable
- •An eye that requires prompt treatment for VMT should not be enrolled
- •Exclusion e. Other ocular condition that might affect visual acuity during the course of the study or require intraocular treatment (e.g., retinal vein occlusion, substantial age-related macular degeneration, or macular edema induced by a condition other than VMT) • If diabetic retinopathy is present, severity level must be microaneurysms only or better (≤ diabetic retinopathy severity level 20)
- •Presence of drusen is acceptable; however, eyes with geographic atrophy or neovascular age-related macular degeneration involving the macula are excluded f. High level of myopia (spherical equivalent of -8.00 diopters or more myopic if phakic or retinal abnormalities consistent with pathologic myopia if phakic or pseudophakic) g. History of prior gas injection, ocriplasmin injection, or intraocular injection for any reason h. History of prior vitrectomy i. History of uncontrolled glaucoma
- •IOP must be <30 mmHg, with no more than one topical glaucoma medication, and no documented glaucomatous field loss for the eye to be eligible j. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery anticipated within the next 6 months following randomization k. History of YAG capsulotomy performed within 4 months prior to randomization l. Aphakia or anterior chamber intraocular lens m. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis n. Uveitis o. Presence of any macular hole or lamellar hole (according to reading center grading) p. Retinal history or pathology that might predispose an eye to an increased risk of retinal detachment from the procedure
- •Untreated retinal tears, not retinal holes, are an exclusion. It is up to the investigator to determine whether extent of lattice degeneration or other pathology might increase the risk of retinal detachment.
- •q. Any contraindication to paracentesis (e.g., history of narrow angle glaucoma) r. Lenticular or zonular instability
结局指标
主要结局
Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy
时间窗: at 24 Weeks
次要结局
- Number of Eyes With Rescue Treatment Before the 24-week Visit(up to 24 weeks)
- Number of Eyes With Central Vitreomacular Traction Status(up to 24 weeks)
- Number of Eyes With Rescue Vitrectomy Completed Before the 24-week Visit or Planned at the 24 Week Visit(through 24 Weeks)
- Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline(Baseline to 24 weeks)
研究者
研究点 (81)
Loading locations...
相似试验
已完成
不适用
Effects of Pneumatic Vitreolysis on Macular HoleVitreomacular Traction (VMT)Full-thickness Macular Holes (MH)NCT03677869Jaeb Center for Health Research36
已完成
3 期
Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular HoleVitreomacular Adhesion Including Macular HoleNCT01429441ThromboGenics220
Unknown
不适用
Early Vitrectomy for Macular Tractional MaculopathyMyopia, DegenerativeNCT01121978Seoul Retina Investigator Group40
已完成
不适用
Postoperative Positioning After Surgery for Macular HolesMacular HolesNCT01974310Glostrup University Hospital, Copenhagen68
已完成
3 期
Treatment of Diabetic Macular Edema: Triamcinolone Injections Vs. Laser PhotocoagulationDiabetic Macular EdemaDMEDiabetic RetinopathyNCT00105404National Eye Institute (NEI)5