New Diagnostic Paradigms for the Identification of Early Glaucomatous Damage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Prevalence of early glaucomatous damage detected by multimodal imaging
研究概览
简要总结
This observational study aims to identify early diagnostic markers of glaucomatous damage by combining functional and structural assessments. Patients with primary open-angle glaucoma and ocular hypertension will undergo comprehensive ophthalmological evaluation, including visual field testing and multimodal imaging of the optic nerve and retina. Both retrospective and prospective data will be collected. The main objective is to define new diagnostic paradigms for detecting early glaucomatous changes and to improve the accuracy of current clinical practice in glaucoma management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 90 years.
- •Best-corrected visual acuity ≥ 0.1 LogMAR (≥ 8/10).
- •For primary open-angle glaucoma (POAG):
- •IOP ≥ 21 mmHg with normal visual field and/or normal optic nerve head/RNFL, or
- •Suspicious optic nerve head (excavation), or
- •Reproducible glaucomatous visual field defect.
- •POAG patients stratified by visual field mean deviation (MD): -3 to -10 dB (S1-S2 Brusini classification).
排除标准
- •Best-corrected visual acuity worse than 0.1 LogMAR (< 8/10).
- •Ocular surgery in the last 6 months (except uncomplicated cataract extraction).
- •Previous vitreoretinal surgery for macular pathologies (e.g., macular pucker, macular hole) or retinal detachment.
- •High myopia (> -3 diopters).
- •Optic disc anomalies not attributable to glaucoma (tilted disc, papillary drusen, other morphological/functional anomalies).
- •Severe motor disability preventing proper positioning for tests.
- •Cognitive impairment reducing test reliability.
结局指标
主要结局
Prevalence of early glaucomatous damage detected by multimodal imaging
时间窗: Baseline to 24 months
Evaluation of structural parameters from OCT and OCTA and functional indices from visual field testing to detect early glaucomatous damage in ocular hypertensive and glaucoma patients.
次要结局
- Correlation between OCT structural parameters and visual field indices(Baseline to 24 months)