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RecruitingNCT04310241Updated Mar 4, 2026

Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy

An observational study in Amblyopia and Strabismus, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 6 Months to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by The Cleveland Clinic · Observational

From the registry’s dates

  • Started Feb 2020; still recruiting 6 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
6 Months to 90 Years
Sex
All
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Study summary

Amblyopia and strabismus are characterized by a reduction in visual acuity, contrast sensitivity, grating acuity, vernier acuity, reading difficulties and binocular visual function deficits. Treated patients have residual visual function deficits. The purpose of the current study is to quantify various visual functions in amblyopic and strabismic participants at baseline, during and at the completion of treatment.

Read the detailed description

To examine the response of therapy on visual functions in amblyopic and strabismic participants.

The following visual functions will be measured prior to treatment. Eye movements, contrast sensitivity, grating acuity, visual acuity, vernier acuity, binocular visual functions, reading and visual scanning will be measured. The testing will comprise of one or more of the above paradigms depending on participant's cooperation and understanding as majority of the study participants will be children. The above measurements will be repeated during amblyopia therapy ( which comprises of glasses, patching and/or atropine eye drops) and at the completion of treatment. For participants with strabismus requiring strabismus surgery the measurements will be repeated after strabismus surgery.

02

Conditions studied

  • Amblyopia
  • Strabismus
03

In context

Amblyopia

189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.

This study's planned enrollment of 150 is close to the median of 156 across 39 observational studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

children with diagnosis of strabismus and/or amblyopia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • History of amblyopia or presence of amblyogenic risk factors.

Exclusion criteria

Exclusion Criteria:

  • History of neurologic disorders
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control subjects

    Subjects who state they have no eye or neurologic problems or disease other than perhaps wearing glasses or contact lenses and upon review of medical history.

  • Amblyopia

    Clinical diagnosis of amblyopia

    Behavioral: Patching therapy, Glasses

Interventions

  • BehavioralPatching therapy, Glasses

    Patching, glasses and strabismus surgery are commonly employed measures in treatment of amblyopia and strabismus.

    Also known as: Strabismus surgery

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What researchers measure

Primary outcomes

  1. Visual Functions

    contrast sensitivity

    Time frame: 0-3 years depending on duration of treatment

  2. Visual Functions

    visual acuity

    Time frame: 0-3 years depending on duration of treatment

  3. Visual functions

    vernier acuity

    Time frame: 0-3 years depending on duration of treatment

  4. Visual functions

    grating acuity

    Time frame: 0-3 years depending on duration of treatment

  5. Visual functions

    binocular functions- stereopsis, inter-ocular functions

    Time frame: 0-3 years depending on duration of treatment

  6. Visual functions

    eye movement measurements

    Time frame: 0-3 years depending on duration of treatment

  7. Visual functions

    reading- reading speeds, eye movement measurements

    Time frame: 0-3 years depending on duration of treatment

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Chatzistefanou KI, Theodossiadis GP, Damanakis AG, Ladas ID, Moschos MN, Chimonidou E. Contrast sensitivity in amblyopia: the fellow eye of untreated and successfully treated amblyopes. J AAPOS. 2005 Oct;9(5):468-74. doi: 10.1016/j.jaapos.2005.05.002. PubMed 16213398 ↗
  • Shaikh AG, Otero-Millan J, Kumar P, Ghasia FF. Abnormal Fixational Eye Movements in Amblyopia. PLoS One. 2016 Mar 1;11(3):e0149953. doi: 10.1371/journal.pone.0149953. eCollection 2016. PubMed 26930079 ↗
  • Ghasia FF, Otero-Millan J, Shaikh AG. Abnormal fixational eye movements in strabismus. Br J Ophthalmol. 2018 Feb;102(2):253-259. doi: 10.1136/bjophthalmol-2017-310346. Epub 2017 Jul 11. PubMed 28698242 ↗

Individual participant data

Plan to share: Yes — Research publications require inclusion of de-identified data in the manuscript. We will also be presenting the data at local, national and international conferences.

Supporting information: Statistical analysis plan, Analytic code

Time frame: starting 6 months after publication

Access criteria: The de-identified research data will be shared with colleagues and will be published after peer-review.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04310241
Responsible party
Fatema Ghasia (Associate Staff, The Cleveland Clinic) — Principal investigator
First posted
Mar 17, 2020
Start date
Feb 21, 2020
Primary completion
Mar 12, 2027 (estimated)
Completion
Mar 12, 2027 (estimated)
Last update
Mar 4, 2026

Study contacts

Kimberly Baynes, MSN
Contact
baynesk@ccf.org
216-444-2566
Fatema Ghasia, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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