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临床试验/NCT01023113
NCT01023113Unknown不适用

To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation

L.V. Prasad Eye Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Comparison of the two methods in relation to visual field loss in terms of MD,CPSD and each quadrants loss of fields

研究概览

简要总结

Lacunae in Knowledge No study is available in literature regarding visual field impairment in proliferative diabetic retinopathy comparing conventional double frequency Nd:YAG panretinal photocoagulation with PASCAL panretinal photocoagulation

AIMS & OBJECTIVE

  1. To compare visual field impairment in conventional double frequency Nd: YAG panretinal photocoagulation with PASCAL panretinal photocoagulation.
  2. To examine the effect of these modalities of laser on macular edema

60 eyes of proliferative diabetic retinopathy will undergo humphery visual field analysis,and optical coherence tomography before and after panretinal photocoagulation

详细描述

Material and Methods

1.Study will be prospective randomized interventional case series. Methods: 60 eyes of proliferative diabetic retinopathy (clear media with no vitreous/significant preretinal hemorrhage) will be taken for the study, out of which 30 eyes will undergo panretinal photocoagulation by conventional frequency doubled Nd: YAG laser and remaining 30 eyes will be by PASCAL laser.

All patients will undergo routine ophthalmic examination (visual acuity, slit lamp, indirect ophthalmoscope, IOP) as well as FFA/seven fields fundus photos (whenever required), OCT(optoview spectral domain OCT), visual fields (Humphrey 30-2 SITA Standard and 60-1) and baseline blood investigation will be done before 1st sitting of laser. Written informed consent will be taken by all the subjects. PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery. In case of clinical significant macular edema modified grid/ focal laser of mild intensity spots will be done. At each visit patient will be assessed for visual acuity, OCT, IOP (applanation tonometer). Patients will be followed up for at least 3 months. After the completion of last sitting of photocoagulation, follow-up will be at one month and 3 months. At one month follow up together with routine ophthalmic examination, OCT, HVF 30-2,60-1 will be done. At final follow-up at 3 months HVF 30-2,60-1,OCT will be done in addition of routine ophthalmic examination and FFA will be done whenever indicated.

Inclusion Criteria

  1. 60 eyes of diabetic patients with proliferative DR will be included.
  2. Visual acuity 20/50 or better in all patients.
  3. Patients available for follow up at least twice between 4-12 weeks.
  4. Patients giving consent for panretinal photocoagulation and for inclusion in study

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
Single (Outcomes Assessor)

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

  • •60 eyes of diabetic patients with proliferative DR will be included.
  • •Visual acuity 20/50 or better in all patients.
  • •Patients available for follow up at least twice between 4-12 weeks.
  • •Patients giving consent for panretinal photocoagulation and for inclusion in study

排除标准

  • •Patients with diseases known to affect visual field as such as aphakia, cataract, glaucoma, optic nerve and macular diseases, will be excluded from the study.
  • •Previous photocoagulation(macular laser or PRP) will also be an exclusion criterion.

研究组 & 干预措施

PASCAL laser, PRP in 2-3 sitting at 3 days interval.

Experimental

PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery by PASCAL laser

干预措施: PASCAL laser (Procedure)

Conventional laser

Active Comparator

PRP will be completed in 2-3 sitting at 3 days interval with one spots apart and moderate intensity gray burns will be given between arcade to periphery by conventional laser

干预措施: Conventional laser (Procedure)

结局指标

主要结局

Comparison of the two methods in relation to visual field loss in terms of MD,CPSD and each quadrants loss of fields

时间窗: 3 months

次要结局

  • Effect on macular edema in terms of OCT thickness(3 months)

研究者

申办方类型
Other

研究点 (1)

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