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临床试验/NCT02995629
NCT02995629已完成不适用

Patient Comfort Using Green (532 nm) Versus Yellow (577 nm) Laser Indirect Ophthalmoscopy Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Wills Eye1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Perceived patient pain assessment

研究概览

简要总结

Our aim is to compare patient comfort when using the 532 nanometer (green) wavelength laser to the 577 nanometer (yellow) wavelength laser during pan retinal photocoagulation to treat patients with diabetic retinopathy. Secondary outcome measures will be power (mW) required to achieve gray-white retinal burns and duration of treatment.

详细描述

As demonstrated in the Diabetic Retinopathy Study (DRS), panretinal photocoagulation (PRP) reduces the risk of severe vision loss in patients with proliferative diabetic retinopathy. The DRS recommended that PRP treatment consist of 1,200 - 1,600 laser burns 500 µm in size, one half to one burn width apart, applied to the peripheral retina in a scatter fashion. Most patients who undergo PRP experience discomfort/pain during the procedure. Once present, pain can affect the number and quality of burns delivered and can indirectly increase the number of sessions required to complete the therapy.This may in turn adversely affect patient compliance. Although retrobulbar and peribulbar blocks can provide adequate anesthesia for PRP, these anesthetic methods carry rare but serious risks such as retrobulbar hemorrhage. Previous studies have explored other ways to reduce discomfort related to PRP, including optimization of laser settings, oral and topical analgesics, subconjunctival anesthesia, and even acupuncture.

Currently, green lasers (521 - 532 nm wavelength) are most commonly utilized for performing PRP in clinical practice. Yellow lasers (577 nm wavelength) have been of recent interest in treating diabetic macular edema with micropulse subthreshold grid photocoagulation, but have not been extensively studied in PRP for diabetic retinopathy. Compared to shorter wavelength laser, yellow laser comports high transmission through dense ocular media and less light scattering than shorter wavelengths which minimizes spot size and reduces thermal spread. The limited literature comparing green and yellow laser for PRP in diabetic retinopathy has shown that yellow laser requires less power to achieve a retinal burn. In theory this should translate into a reduction in perceived pain experienced during PRP, however a comparison of green and yellow lasers in this regard has not yet been directly examined and quantified.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

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

  • •patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina
  • •volunteer patients age 18 years and older.
  • •healthy enough to participate in the study.
  • •willing and able to consent to participation in the study.
  • •diagnosis of PDR with HRC based on clinical criteria outlined by the DRS.

排除标准

  • •patient less than 18 years of age
  • •institutionalized patient
  • •significant media opacity obscuring a view of the superior retina
  • •history of intra-ocular surgery except cataract surgery
  • •history of PRP laser within the last 30 days

研究组 & 干预措施

green (532 nm) laser

Experimental

scatter laser indirect ophthalmoscopy pan retinal photocoagulation

干预措施: laser indirect ophthalmoscopy pan retinal photocoagulation (Procedure)

yellow (577 nm) laser

Experimental

scatter laser indirect ophthalmoscopy pan retinal photocoagulation

干预措施: laser indirect ophthalmoscopy pan retinal photocoagulation (Procedure)

结局指标

主要结局

Perceived patient pain assessment

时间窗: a single time point within 2 minutes of completing laser treatment

Assessed using a standardized Wong-Baker faces pain scale

次要结局

  • Minimum power requirement to achieve moderate gray-white retinal burns(During treatment)
  • Time of treatment(During treatment)

研究者

发起方
Wills Eye
申办方类型
Other
责任方
Principal Investigator
主要研究者

MidAtlantic Retina

Dr. Allen Chiang, MD

Wills Eye

研究点 (1)

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