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临床试验/NCT04566237
NCT04566237已完成不适用

Objective Measurements of the Opacification of the Lens After Vitrectomy

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年9月21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
入组人数
44
试验地点
1
主要终点
Change in ALD value between baseline and 12 months after the intervention

研究概览

简要总结

Cataract is the opacification of the lens. Usually cataract occurs slowly, causing progressive vision loss over several months or years.

In ophthalmic clinical practice, repeated objective quantitative measurements of lens opacity may be necessary to document its progression and support a surgical indication.

The subjective methods of evaluating the opacification of the lens have limitations, in particular due to the lack of reproducibility between observers. Thus, innovative objective techniques with precise and reproducible cataract classification results have been developed, such as the Objective Scatter Index (OSI) on the Optical Quality Analysis System (OQAS), Visiometrics SL in 2010 and, more recently, Average Lens Density (ALD) on the IOLMaster® 700 device. Cataract is diagnosed as mature when the OSI is ≥ 2 and / or when the ALD is ≥ 74 pixel units.

Vitrectomy is a surgery of the posterior segment of the eye indicated for retinal detachment, epimacular membranes, macular holes, vitreous hemorrhage. The incidence of post-vitrectomy cataract varies among studies, and the methodology is often retrospective. Age has already been identified as a risk factor for progression since in a study of 28 eyes of patients under 50 years old, only 7% developed cataracts secondarily, compared to 79% in the 'over 50' group.

To date, there is no prospective study describing the progression kinetics of lens opacification according to precise and reproducible quantitative objective criteria in patients treated by vitrectomy. It also involves confirming the age and preoperative lens status as a risk factor for postoperative cataract progression.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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
是

入选标准

  • •Patient over 18 years old
  • •Indication for unilateral 3-way vitrectomy for retinal detachment, macular hole, epiretinal membrane, vitreous hemorrhage
  • •Bilateral phakic patient

排除标准

  • •Vitrectomy combined with cataract surgery
  • •Pregnant or breastfeeding woman

研究组 & 干预措施

24 months follow up after vitrectomy

Experimental

Objective Scatter Index (OSI) and Average Lens Density (ALD) at inclusion, then 3 months, 12 months and 24 months after vitrectomy

干预措施: Objective Scatter Index (OSI) (Procedure)

24 months follow up after vitrectomy

Experimental

Objective Scatter Index (OSI) and Average Lens Density (ALD) at inclusion, then 3 months, 12 months and 24 months after vitrectomy

干预措施: Average Lens Density (ALD) (Procedure)

结局指标

主要结局

Change in ALD value between baseline and 12 months after the intervention

时间窗: Baseline and 12 months after vitrectomy

ALD value : quantitative variable expressed in pixel units

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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