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临床试验/NCT01383772
NCT01383772已完成不适用

A Prospective Clinical Study of the Effects of Panretinal Photocoagulation Delivered With a Multi-spot Photocoagulator on Retinal Sensitivity and Driving Eligibility in Patients With Diabetic Retinopathy

Moorfields Eye Hospital NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Risk of failing visual field criteria to hold a driving licence.

研究概览

简要总结

The purpose of this study is to determine the risk of failing the visual field criteria to hold a driving license following retinal laser treatment delivered with a multi-spot photocoagulator.

详细描述

Despite improvements in the management of diabetes, the incidence of severe diabetes -related eye disease remains high. Laser treatment (panretinal photocoagulation (PRP)) is the gold standard treatment for reducing the risk of visual loss. However, evidence suggests that PRP can be damaging on visual field function and thus jeopardize patients' eligibility to drive. In the UK, it is the patient's responsibility to inform the DVLA that they are receiving retinal laser.

With the use of a multi-spot Photocoagulator for application of PRP at Moorfields the investigators are in a unique position to assess the effects of laser applied with this new delivery system on visual fields in a detailed fashion. Thus providing more accurate advice on visual prognosis and visual field function and addressing the risk of losing the ability to drive.

All treatment-naive patients with severe diabetic retinopathy requiring bilateral retinal laser treatment will be identified. Following informed consent these patients will undergo baseline visual field testing which will be of a duration of approximately 30 minutes and complete a quality of life questionnaire. All patients will receive their laser treatment as part of standard clinical care via the multi-spot Photocoagulator which will require approximately four 20 minute sessions. At 6 months following the completion of treatment the patients will undergo repeat visual field testing as conducted at baseline and complete a quality of life questionnaire. The investigators hope to recruit 100 patients.

Analysis of visual fields will principally involve assessment of whether patients have met the UK driving standards on Estermann VF testing. A quantitative assessment of change in retinal sensitivity will be undertaken by comparing retinal sensitivity pre and post-PRP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of either sex aged 18 years or over.
  • Diabetes mellitus (type 1 or type 2).
  • Best corrected visual acuity (BCVA) > or equal 6/60 in both eyes.
  • Requiring full bilateral PRP.
  • No previous laser treatment.
  • Subject cooperation sufficient for adequate visual field testing.
  • Ability to return for regular study visits.

排除标准

  • Co-existent ocular/systemic condition that may affect visual field.
  • Visual acuity less than 6/60 that may affect accuracy of visual field test.
  • Presence of vitreous haemorrhage.
  • Intraocular surgery/other intervention anticipated in either eye during the duration of treatment and VF assessment.
  • Previous PRP.
  • Age below 18.

结局指标

主要结局

Risk of failing visual field criteria to hold a driving licence.

时间窗: visual fields at baseline and at 6 months.

All patients requiring bilateral PRP will be identified. These patients will undergo binocular and uniocular full-field static and kinetic visual field testing; All patients will receive their PRP via the multi-spot Photocoagulator using standardised parameters for treatment. At 6 months following the completion of PRP the patients will undergo repeat visual field testing as conducted at baseline. Analysis of visual fields will principally involve qualitative assessment of whether patients have met the UK driving standards on Estermann VF testing.

次要结局

  • Visual field assessment prior to planned pan retinal photocoagulation(at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michel Michaelides

Consultant and Professor of Ophthalmology

Moorfields Eye Hospital NHS Foundation Trust

研究点 (2)

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