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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.
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:
Study participants will be recruited from the ophthalmology outpatient clinics of Minia University Hospitals. Imaging will be performed in the Department of Ophthalmology, Minia University Hospital.
Study will include 75 eyes that will be divided into 3 groups:
Group A: normal eyes of age-matched controls. Group B: amblyopic eyes treated with patching. Group C: amblyopic treated with patching and flouxetine.
Ophthalmic Examination:
All patients will undergo a thorough ocular and systemic history taking, as well as a comprehensive ophthalmic examination before, 3 months after patching and fluoxetine therapy and 3 months after therapy withdrwal, including:Uncorrected visual acuity (UCVA).
Investigations:
Ophthalmic imaging:
OCT-A (Optovue Inc. Fremont, CA, USA).
OCT-A technique:
OCT-A scans were done using AngioVue OCTTM system on RTVue XR 100 Avanti spectral domain-OCT device, version 2015 (Optovue Inc, Fremont, CA, USA).
Technique:
OCT-A print out:
The print out of the gray scale angiovue retinal scan included:
Across the top, four angiovue en-face images at different depths:
In this study, OCT-A parameters that were compared in this study include vessel density in SCP, DCP and chorio-capillaris layers in either the whole image of central 6 mm, foveal and para-foveal regions as well as FAZ area.
Flash VEP (FVEP) and pattern VEP (PVEP) Ophthalmic functional assessment by FVEP and PVEP will be performed for all patients before, 3 months after patching and fluoxetine therapy and 3 months after therapy withdrwal. FVEP and PVEP will be done using the (Roland Consult supercolor Ganzfeld Q450 SC).
FVEP Ganzfeld
Requirement:
Requirement:
Distance patient → monitor: 100 cm
Light-adapted Patient (photopic conditions)
Patient refraction / correction for 100 cm viewing distance
3x EEG-Electrodes at channel 1 One eye covered
Impedance < 10 kOhm Outcome Measures
FVEP: latency and amplitude of P2.
PVEP: latency and amplitude of P100.
Statistical Analysis:
Data analyses were performed using statistical package for the social science (SPSS) software version 26. Demographic and outcome data were presented as mean± standard deviation for continuous variables with normal distribution.
Categorical variables were reported as frequency (sex). Shapiro-Wilk test and Kolmogorov Simonov test were performed to test the normality of the data. One way ANOVA test was done to compare results between 3 groups and a two sided p < 0.05 was considered as statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group | Active Comparator | Flouxetine and patching therapy. |
|
| Control group | No Intervention | other normal eye not amblyobic | |
| Only patching group | Sham Comparator | treated by patching without drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flouxetine | Drug | drug to increase neuroplasticity in amblyopia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of best corrected visual acuity with LogMAR | measurement of Best corrected visual acuity using LogMAR in the three groups. | 6 months |
| measuring amplitude of P wave in visual evoked potential | 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). | 6 months |
| measuring the vessel density in OCTA using the Avanti RTVue-XR system (Optovue, Fremont, CA, USA) | comparing the vessel density in OCTA between the three groups. | 6 months |
| measuring latency of P wave in visual evoked potential | 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). | 6 months |
| measuring the foveal avascular zone in OCTA using the Avanti RTVue-XR system (Optovue, Fremont, CA, USA) | comparing the foveal avascular zone in OCTA between the three groups. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Ocular pathology: media opacity, uveitis, glaucoma, retinal or optic nerve diseases, and history of ocular trauma.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alyaa A Abdelmonaem, phD | Contact | 01097814574 | 02 | alyaa_medicine@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Minia university | Recruiting | Minya | Minya Governorate | 61511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33783486 | Result | Nishikawa N, Chua J, Kawaguchi Y, Ro-Mase T, Schmetterer L, Yanagi Y, Yoshida A. Macular Microvasculature and Associated Retinal Layer Thickness in Pediatric Amblyopia: Magnification-Corrected Analyses. Invest Ophthalmol Vis Sci. 2021 Mar 1;62(3):39. doi: 10.1167/iovs.62.3.39. | |
| 20714361 | Result | Moschos MM, Margetis I, Tsapakis S, Panagakis G, Chatzistephanou IK, Iliakis E. Multifocal visual evoked potentials in amblyopia due to anisometropia. Clin Ophthalmol. 2010 Aug 9;4:849-53. doi: 10.2147/opth.s11762. |
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after publication
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2025 | Feb 10, 2026 |
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Amblyopia in different age groups
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| Patching therapy |
| Behavioral |
covering the sound eye and fixation by the amblyopic |
|
| 32685403 | Result | Milla M, Pinero DP. Characterization, passive and active treatment in strabismic amblyopia: a narrative review. Int J Ophthalmol. 2020 Jul 18;13(7):1132-1147. doi: 10.18240/ijo.2020.07.18. eCollection 2020. |
| 37323584 | Result | Marenna S, Rossi E, Huang SC, Castoldi V, Comi G, Leocani L. Visual evoked potentials waveform analysis to measure intracortical damage in a preclinical model of multiple sclerosis. Front Cell Neurosci. 2023 May 31;17:1186110. doi: 10.3389/fncel.2023.1186110. eCollection 2023. |
| 35911423 | Result | Lu H, Zhang T, Yue T, Li X, Ma B, Liu H. Analysis of Optic Nerve in Adults With Amblyopia Using OCTA. Front Med (Lausanne). 2022 Jul 14;9:903228. doi: 10.3389/fmed.2022.903228. eCollection 2022. |
| 37153796 | Result | Gacoin M, Ben Hamed S. Fluoxetine degrades luminance perceptual thresholds while enhancing motivation and reward sensitivity. Front Pharmacol. 2023 Apr 20;14:1103999. doi: 10.3389/fphar.2023.1103999. eCollection 2023. |
| 22144947 | Result | Baroncelli L, Maffei L, Sale A. New perspectives in amblyopia therapy on adults: a critical role for the excitatory/inhibitory balance. Front Cell Neurosci. 2011 Nov 24;5:25. doi: 10.3389/fncel.2011.00025. eCollection 2011. |
| 19503473 | Result | Bachmann A, Leitgeb R, Lasser T. Heterodyne Fourier domain optical coherence tomography for full range probing with high axial resolution. Opt Express. 2006 Feb 20;14(4):1487-96. doi: 10.1364/oe.14.001487. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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