CORRELATION OF RETINAL NERVE FIBRE LAYER THICKNESS AS MEASURED BY OPTICAL COHERENCE TOMOGRAPHY WITH VISUAL FIELDS BY HUMPHREY FIELD ANALYSER IN EARLY AND MODERATE OPEN – ANGLE GLAUCOMAS.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Structure - function correlation in early and moderate open – angle glaucoma with regards to RNFL thickness and visual field indices.
研究概览
简要总结
Glaucomais an optic neuropathy characterised by progressive degeneration of retinalganglion cells and axons that leads to nerve fibre loss, optic disc cupping,and consecutive glaucomatous visual field defects. It is considered to be oneof the major causes of blindness worldwide. Itis a well accepted fact least 25 – 40% of retinal ganglion cells need to belost before statistically detectable visual field defects appear on automatedvisual field testing, which is also consistent with post – mortem histologicfindings in glaucomatous eyes. Sincethe damage associated with glaucoma is irreversible, and RNFL loss isconsidered as an early sign of glaucomatous damage, its early detection andprevention is warranted. RNFL studies can be undertaken through non – invasive,reproducible technologies such as optical coherence tomography, scanning laserpolarimetry etc. Themain purpose of the study is to evaluate the relationship between visual fieldsand RNFL thickness as measured by Cirrus spectral domain optical coherencetomography ((SD – OCT, Carl ZeissMeditec Inc. , Dublin, CA.) with visual fields by Humphrey Field Analyser (HFA)in early and moderate primary open – angle glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subjects visiting a glaucoma clinic diagnosed with primary open – angle glaucoma.
- •â€¢Subjects should have best corrected visual acuity not less than 6/
- •â€¢Refractive spherical error within the range of -6.00DS to + 3.00 DS and cylindrical error within +/- 2.5D.
- •â€¢Visual fields examination of the subjects demonstrating field defects secondary to glaucomatous damage with mean deviation ranging from -2 to -10 decibels (db).
- •â€¢The visual fields of the subjects should be within the reliability criteria (<20% fixation losses, false positives and false negatives).
- •â€¢The signal to noise ratio for a reliable OCT – RNFL scan shall not be less than 6.
排除标准
- •â€¢History of(H/O) retinal disease or photocoagulation.
- •â€¢H/O ocular trauma or surgery except an uncomplicated cataract surgery.
- •â€¢H/O other optic nerve disease except glaucoma •H/O amblyopia •Neurological disease which can affect visual fields.
- •â€¢Visually significant cataracts (Posterior Subcapsular Cataracts, > N.S Grade II).
结局指标
主要结局
Structure - function correlation in early and moderate open – angle glaucoma with regards to RNFL thickness and visual field indices.
时间窗: At time of presentation over the glaucoma outpatient department
次要结局
- Pattern of visual field loss and retinal nerve fibre layer changes in early and moderate primary open angle glaucoma.(At time of presentation to the glaucoma outpatient department.)