AmblyopiaNCT04310241
Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy
An observational study of Amblyopia and Strabismus, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 90 years
- Conditions the study is for
- Amblyopia, Strabismus
- What is being tested?
- Patching therapy, Glasses
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2020to 12 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children with diagnosis of strabismus and/or amblyopia
Who may be able to join
- History of amblyopia or presence of amblyogenic risk factors.
Who cannot join
- History of neurologic disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Fatema Ghasia, MD, 216 318 7809
Kimberly Baynes, 2164442566, baynesk@ccf.org
About this study
Official title: Oculomotor Disorders: Experimental and Clinical Study
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.
- Conditions
- Amblyopia, Strabismus
- Being tested
- Patching therapy, Glasses
- Medical subject headings
- Amblyopia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patching therapy, GlassesBehavioural
Also called Strabismus surgery
Patching, glasses and strabismus surgery are commonly employed measures in treatment of amblyopia and strabismus.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Patching therapy, Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Functions
contrast sensitivity
Measured: 0-3 years depending on duration of treatment
Visual Functions
visual acuity
Measured: 0-3 years depending on duration of treatment
Visual functions
vernier acuity
Measured: 0-3 years depending on duration of treatment
Visual functions
grating acuity
Measured: 0-3 years depending on duration of treatment
Visual functions
binocular functions- stereopsis, inter-ocular functions
Measured: 0-3 years depending on duration of treatment
Visual functions
eye movement measurements
Measured: 0-3 years depending on duration of treatment
Visual functions
reading- reading speeds, eye movement measurements
Measured: 0-3 years depending on duration of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start21 Feb 2020
- Primary completion12 Mar 2027 (estimated)
- Study completion12 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatema Ghasia, The Cleveland Clinic
- Investigators
- Fatema Ghasia, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310241
- Sponsor's protocol ID
- 12-915
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2020
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 16213398Shaikh 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 26930079Ghasia 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oculomotor Disorders: Experimental and Clinical Study
- ClinicalTrials.gov ID
- NCT04310241
- Acronym / sponsor ID
- 12-915
- Conditions
- Amblyopia, Strabismus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 12 Mar 2027 (estimated)
- Study completion
- 12 Mar 2027 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: Patching therapy, GlassesClinical diagnosis of amblyopia |
Who may qualify
- Ages
- 6 months to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children with diagnosis of strabismus and/or amblyopia
Key inclusion criteria (1 listed)
- History of amblyopia or presence of amblyogenic risk factors.
Key exclusion criteria (1 listed)
- History of neurologic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patching therapy, GlassesAlso: Strabismus surgeryPatching, glasses and strabismus surgery are commonly employed measures in treatment of amblyopia and strabismus. | Behavioural | Amblyopia |
Primary outcome
Visual Functions
Time frame: 0-3 years depending on duration of treatment
contrast sensitivity
Visual Functions
Time frame: 0-3 years depending on duration of treatment
visual acuity
Visual functions
Time frame: 0-3 years depending on duration of treatment
vernier acuity
Visual functions
Time frame: 0-3 years depending on duration of treatment
grating acuity
Visual functions
Time frame: 0-3 years depending on duration of treatment
binocular functions- stereopsis, inter-ocular functions
Visual functions
Time frame: 0-3 years depending on duration of treatment
eye movement measurements
Visual functions
Time frame: 0-3 years depending on duration of treatment
reading- reading speeds, eye movement measurements
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 16213398Chatzistefanou 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.
- Results publication: PubMed 26930079Shaikh 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.
- Results publication: PubMed 28698242Ghasia 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatema Ghasia, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amblyopia and Strabismus, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Baynes, MSN (216-444-2566, baynesk@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Functions (time frame: 0-3 years depending on duration of treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04310241, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.