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)
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
- 否
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
Flouxetine and patching therapy.
干预措施: Flouxetine (Drug)
Treated group
Flouxetine and patching therapy.
干预措施: Patching therapy (Behavioral)
Control group
other normal eye not amblyobic
Only patching group
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
Alyaa Abdelfattah Abdelmonaem Gad
Associate professor of pharmacology, faculty of medicine, Minia university
Minia University
