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临床试验/NCT07417046
NCT07417046招募中不适用

Possible Beneficial Effects Of Combined Fluoxetine And Occlusion Therapy In Improving And Maintaining Vision In Amblyopia Using Optical Coherence Tomography Angiography (OCTA) And Visual Evoked Potential (VEP)

Minia University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
assessment of best corrected visual acuity with LogMAR

研究概览

简要总结

Amblyopia is described as a limitation of the visual function of one or both eyes with no pathological cause, with a prevalence of about 1-5% of the total world population. This disorder is caused by early abnormal visual experience with a functional imbalance between the two eyes owing to anisometropia, strabismus, congenital cataract and ptosis, resulting in a dramatic loss of visual acuity (VA) in an apparently healthy eye.

Clinically, amblyopia can be defined as the presence in one or both eyes of a VA of 6/12 or worse, with one or more lines of difference in VA between eyes in unilateral amblyopia which cannot be improved by refractive correction. This condition is an alteration of the visual cortex function which is due to suppression and deprivation of one eye leading to unilateral visual deterioration.

Optical coherence tomography (OCT) is a noninvasive technique that can reveal morphology of the retinal layers in vivo. OCT determines structural changes in the macula that may be correlated with measures of subjective visual function such as visual acuity and visual field. OCT angiography (OCTA) can provide vascular system visualization of the posterior segment in amblyopic eyes.

Visual evoked potentials (VEPs) are a non-invasive technique routinely used in clinical and preclinical practice. VEPs allow to quantify the functional integrity of the visual system from the retina via the optic nerves, optic tracts, to the thalamus, and form projections to the visual cortices.

In strabismic and anisometropic amblyopia, VEP responses are reduced. VEP may be used as an alternative objective method for diagnosis and monitoring of amblyopia.

Passive treatments such as occlusion, optical and/or pharmacological penalization, and Bangerter foils have been demonstrated to be potentially useful treatments for amblyopia. Researches are being done on new pharmacological options to improve and maintain VA after occlusion treatment in amblyopia.

Adults with amblyopia cannot be treated because their brains do not have enough plasticity. However, results obtained both in clinical trials and in animal models have challenged this traditional view, unmasking a previously unsuspected potential for promoting recovery after the end of the critical period for visual cortex plasticity. These studies point toward the intracortical inhibitory transmission as a crucial brake for therapeutic rehabilitation and recovery from amblyopia in the adult brain.

Selective serotonin reuptake inhibitors (SSRIs) increase serotonin activity in the brain. While they are mostly known for their antidepressant properties, they have been shown to improve visual functions in amblyopia and impact cognitive functions ranging from attention to motivation and sensitivity to reward.

详细描述

Study Design:

• A prospective clinical non-randomized comparative controlled study.

Ethical Consideration:

All patients and control subjects included in this study were verbally briefed about the details and the nature of the study. Informed consent was obtained from all patients included in the study. The study was approved by local ethical committee of Minia University Faculty of Medicine and was adherent to the tenets of Declaration of Helsinki and the approval number was 1288/2024.

Study Population:

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unilateral amblyopia > 10 years old.

排除标准

  • Ocular pathology: media opacity, uveitis, glaucoma, retinal or optic nerve diseases, and history of ocular trauma.
  • Poor fixation.
  • Lack of cooperation.
  • Any psychological disorder.

研究组 & 干预措施

Treated group

Active Comparator

Flouxetine and patching therapy.

干预措施: Flouxetine (Drug)

Treated group

Active Comparator

Flouxetine and patching therapy.

干预措施: Patching therapy (Behavioral)

Control group

No Intervention

other normal eye not amblyobic

Only patching group

Sham Comparator

treated by patching without drug

干预措施: Patching therapy (Behavioral)

结局指标

主要结局

assessment of best corrected visual acuity with LogMAR

时间窗: 6 months

measurement of Best corrected visual acuity using LogMAR in the three groups.

measuring amplitude of P wave in visual evoked potential

时间窗: 6 months

measuring the amplitude in micro-voltage of P wave of visual evoked potential in the three groups and comparing them using the (Roland Consult supercolor Ganzfeld Q450 SC).

measuring the vessel density in OCTA using the Avanti RTVue-XR system (Optovue, Fremont, CA, USA)

时间窗: 6 months

comparing the vessel density in OCTA between the three groups.

measuring latency of P wave in visual evoked potential

时间窗: 6 months

measuring the latency in milli-seconds of P wave of visual evoked potential in the three groups and comparing them using the (Roland Consult supercolor Ganzfeld Q450 SC).

measuring the foveal avascular zone in OCTA using the Avanti RTVue-XR system (Optovue, Fremont, CA, USA)

时间窗: 6 months

comparing the foveal avascular zone in OCTA between the three groups.

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alyaa Abdelfattah Abdelmonaem Gad

Associate professor of pharmacology, faculty of medicine, Minia university

Minia University

研究点 (1)

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