Combined fluoxetine and patching to improve and maintain vision in amblyopia using OCTA and VEP
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)
NA · Minia University · NCT07417046
This project will test whether adding fluoxetine to standard eye patching helps improve and maintain vision in people over 10 with amblyopia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | Minia University (other) |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07417046 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomized comparative controlled study enrolling 75 eyes into three groups: age-matched normal controls, amblyopic eyes treated with patching alone, and amblyopic eyes treated with patching plus fluoxetine. Participants undergo comprehensive eye exams including BCVA, refraction, IOP, OCTA imaging of the macula, and visual evoked potentials (VEP) at baseline, after three months of therapy, and three months after stopping therapy. The study is conducted at the Department of Ophthalmology, Minia University Hospital, with informed consent and local ethics approval. Outcomes focus on changes in visual acuity and neurovascular retinal measures to see if fluoxetine adds benefit to patching.
Who should consider this trial
Good fit: Ideal candidates are people older than 10 with unilateral amblyopia who can cooperate with testing and have no other ocular or major psychiatric conditions.
Not a fit: Patients with bilateral amblyopia, media opacity, retinal or optic nerve disease, glaucoma, poor fixation, or significant psychological disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding fluoxetine to patching could improve visual acuity and help preserve those gains in older children and adults with unilateral amblyopia.
How similar studies have performed: Preclinical work and a few small human studies suggest SSRIs like fluoxetine can boost neural plasticity and might aid visual recovery, but clinical evidence in amblyopia is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with unilateral amblyopia \> 10 years old. Exclusion Criteria: * Ocular pathology: media opacity, uveitis, glaucoma, retinal or optic nerve diseases, and history of ocular trauma. * Poor fixation. * Lack of cooperation. * Any psychological disorder.
Where this trial is running
Minya, Minya Governorate
- Faculty of medicine, Minia university — Minya, Minya Governorate, Egypt (RECRUITING)
Study contacts
- Study coordinator: Alyaa A Abdelmonaem, phD
- Email: alyaa_medicine@yahoo.com
- Phone: 01097814574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amblyopia, VEP, Flouxetine, OCTA