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). The Aim Of The Study Is To Evaluate Possible Beneficial Effects For Different Age Groups.

NCT07417046 | Recruiting

• 1 other identifier: 1288/2024.
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amblyopia; VEP

Keywords

Flouxetine; VEP; OCTA; Amblyopia

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Treated group

ACTIVE COMPARATOR

Flouxetine and patching therapy.

Drug: Flouxetine; Behavioral: Patching therapy

Control group

NO INTERVENTION

other normal eye not amblyobic

Only patching group

SHAM COMPARATOR

treated by patching without drug

Behavioral: Patching therapy

Interventions

Flouxetine DRUG

drug to increase neuroplasticity in amblyopia

Treated group

Patching therapy BEHAVIORAL

covering the sound eye and fixation by the amblyopic

Only patching group; Treated group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unilateral amblyopia \> 10 years old.

You may not qualify if:

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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of medicine, Minia university

Minya, Minya Governorate, 61511, Egypt

RECRUITING

Related Publications (8)

• 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.

  PMID: 33783486 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.

  PMID: 20714361 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.

  PMID: 32685403 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.

  PMID: 37323584 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.

  PMID: 35911423 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.

  PMID: 37153796 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.

  PMID: 22144947 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.

  PMID: 19503473 RESULT

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alyaa A Abdelmonaem, phD

CONTACT

01097814574; alyaa_medicine@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of pharmacology, faculty of medicine, Minia university

Model Details: Amblyopia in different age groups

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 18, 2026
• Study Start: December 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)