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临床试验/NCT02644720
NCT02644720Unknown不适用

Neural Compensation, Visual Function and Visual Quality in Senile Cataract Patients After Monofocal or Multifocal Intraocular Lens Implantation

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Change from functional magnetic resonance imaging

研究概览

简要总结

Multifocal intraocular lenses (MIOLs) provide enhanced far and near visual acuity, but they can bring about halos and glare, which are caused by design deficiencies of the IOLs. Compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may increase the difficulty of neural compensation reconstruction in patients with multifocal intraocular lens implantation. Patients enrolled into the study will be followed for 1 year and will have study visits preoperatively, at 1 week, 3 months, 6 months, 12 months postoperatively.In this trial, we aimed to specify the time of neural compensation reconstruction in patients and to explore the changes of visual function in senile patients with monofocal or multifocal intraocular lens implantation.

详细描述

Cataract extraction and intraocular lens (IOL) implantation are the current standard treatments for age-related cataract (ARC). Cataract surgery increases visual acuity but may lead to complaints after surgery. Multifocal intraocular lenses (MIOLs) provide enhanced far and near visual acuity, but they can bring about halos and glare, which are caused by design deficiencies of the IOLs. Fortunately, most of the halos and glare diminish with time. Niels et al noted that neural adaptation (NA) may explain the lower incidence of glare and halos in their study. Compared to monofocal intraocular lens, pseudo accommodation in nonphysiological state may increase the difficulty of neural compensation reconstruction in patients with multifocal intraocular lens implantation.

In the present study, the investigators evaluated the activity of neurons in the visual cortex using fMRI both preoperatively and postoperatively. In addition, the investigators evaluated postoperative changes in VF, including visual acuity (VA), contrast sensitivity (CS), straylight values (SVs), and pattern visual evoked potential (PVEP), stereoscopic vision, wavefront aberrations at 1 week, 3 months, 6 months, 12 months postoperatively.In this trial, the investigators aimed to specify the time of neural compensation reconstruction in patients and to explore the changes of visual function in senile patients with monofocal or multifocal intraocular lens implantation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • visual acuity less than 0.3
  • Cataracts in both eyes classified by the Lens Opacity Classification System III
  • Corneal astigmatism less than 1.5 diopters (D)
  • Capability of understanding and signing the informed consent

排除标准

  • Corneal astigmatism ≥ 1.5D.
  • History of neurological or psychiatric disorders; systemic disease such as severe hypertension or diabetes mellitus that might interfere with the visual outcomes.
  • Associated ocular disease that could interfere with final results
  • Previous anterior and posterior segment surgery and intraoperative or postoperative complications
  • Driving at night frequently; excessive expectations for visual outcomes

研究组 & 干预措施

multifocal intraocular lens group

Experimental

干预措施: multifocal intraocular lens implantation (Procedure)

multifocal intraocular lens group

Experimental

干预措施: Dexamethasone (Drug)

multifocal intraocular lens group

Experimental

干预措施: multifocal intraocular lens (IOL) (Tecnis ZMB00) (Device)

monofocal intraocular lens group

Active Comparator

干预措施: monofocal intraocular lens implantation (Procedure)

monofocal intraocular lens group

Active Comparator

干预措施: Dexamethasone (Drug)

monofocal intraocular lens group

Active Comparator

干预措施: monofocal intraocular lens (IOL) (Tecnis ZCB) (Device)

结局指标

主要结局

Change from functional magnetic resonance imaging

时间窗: 1 week, 1 month, 3 month, 6 month,1 year after surgery

Change from contrast sensitivity

时间窗: 1 week, 1 month, 3 month, 6 month,1 year after surgery

Contrast sensitivity (CS) was tested with a Contrast Glare Tester 1000

次要结局

  • Change from best corrected visual acuity(1 week, 1 month, 3 month, 6 month,1 year after surgery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haotian Lin

Professor in Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center

Sun Yat-sen University

研究点 (1)

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