AmblyopiaNCT03780205
Bilateral and Unilateral Amblyopia Treatment Study
An observational study of Amblyopia, run by Salus University at 1 site in United States.
Trial summary
The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to <10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Prescription glasses for bilateral amblyopia and Prescription glasses for unilateral amblyopia
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 7 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 10 years
- All sexes
- Child
Study population: Children age at 3 to < 10 years, who is newly diagnosed as amblyopia and prescribed with glasses.
Who may be able to join
- Age 3 to < 10 years
- Subjects and their parent/guardian speak and understand English adequately to complete the study protocol and give informed consent. Subjects have the ability to adhere to the study visit schedule.
- All refractive error measures below will be determined by cycloplegic retinoscopy by one of the study investigators during the comprehensive eye exam. Measures are in minus cylinder spectacle prescription format.
- The major eligibility criteria include:
- Best-corrected visual acuity of <20/30 each eye.
- For hypermetropia:
Show all 21Show fewer
- Spherical equivalent >+2.00 D each eye.
- Spherical equivalent difference between eyes <1.25 D.
- For astigmatism without hypermetropia criteria above or myopia criteria below:
- >1.75 D each eye
- Difference between eyes <1.25 D
- For myopia:
- Spherical equivalent <-5.00.
- Spherical equivalent difference between eyes <1.25 D.
- The major eligibility criteria include:
- Presence of anisometropia or constant unilateral strabismus.
- Best-corrected visual acuity in the amblyopic eye <20/30; and interocular difference of best-corrected visual acuity at least two logMAR lines.
- For anisometropia:
- Spherical equivalent ≥ 1.00 D interocular difference
- Astigmatism >1.75 D interocular difference
- For constant unilateral strabismus where spectacle prescription is indicated. Examples where spectacle prescription is indicated include esotropia caused at least in part by an accommodative component or where significant refractive error in either eye warrants spectacle prescription for improved vision.
Who cannot join
- History of spectacle wear
- Previous treatment for amblyopia
- Active amblyopia treatment planned other than spectacles at enrollment
- Prior intraocular or refractive surgery
- Ocular or systemic abnormalities that the examining investigator deems could impact prognosis for visual improvement. Examples could include birth history that may have affected brain development, extremely low birth weight (<1.5 lbs), seizure disorders, cerebral palsy, optic nerve hypoplasia, cranial nerve palsy. Examples that would usually not exclude are off axis media opacity, low birth weight (2.0-3.5 lbs) without complication, mild limitation of extraocular muscle. Cognitive impairment that prohibits accurate data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Objective Adherence With Optical Correction in Children With Bilateral and Unilateral Refractive Amblyopia
The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to <10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.
Read the detailed description
The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to <10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.
- Conditions
- Amblyopia
- Being tested
- Prescription glasses for bilateral amblyopia, Prescription glasses for unilateral amblyopia
- Keywords
- Amblyopia
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription glasses for bilateral amblyopiaOther
Correction of refractive error with prescription glasses both eyes
Prescription glasses for unilateral amblyopiaOther
Correction of asymmetric refractive errors with lenses
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Group | Patients have bilateral amblyopia, which is defined that best-corrected visual acuity of <20/30 each eye. Receives: Other: Prescription glasses for bilateral amblyopia | |
| Unilateral Group | Patients have unilateral amblyopia, which is defined that best-corrected visual acuity of <20/30 in the amblyopic eye; and interocular difference of best-corrected visual acuity at least two logMAR lines. Receives: Other: Prescription glasses for unilateral amblyopia |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity change from the baseline
visual acuity change from the baseline in logMAR
Measured: 8 weeks
adherence with optical treatment
The adherence recorded with the microsensor will be calculated as a percentage.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Mar 2019
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Why it stopped: Unable to recruit sufficient number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Hatch, OD, MPH, Salus University
- Investigators
- Stanley Hatch, OD, Principal investigator, Salus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780205
- Sponsor's protocol ID
- HJWSH1810
- Status last verified
- Aug 2020
- First submitted
- 17 Dec 2018
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Adherence With Optical Correction in Children With Bilateral and Unilateral Refractive Amblyopia
- ClinicalTrials.gov ID
- NCT03780205
- Acronym / sponsor ID
- HJWSH1810
- Conditions
- Amblyopia
- Keywords
- Amblyopia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient number of subjects
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 19 Dec 2018 (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.
The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to <10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.
Detailed description
The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to <10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral Group | – | Other: Prescription glasses for bilateral amblyopiaPatients have bilateral amblyopia, which is defined that best-corrected visual acuity of <20/30 each eye. |
| Unilateral Group | – | Other: Prescription glasses for unilateral amblyopiaPatients have unilateral amblyopia, which is defined that best-corrected visual acuity of <20/30 in the amblyopic eye; and interocular difference of best-corrected visual acuity at least two logMAR lines. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- Children age at 3 to < 10 years, who is newly diagnosed as amblyopia and prescribed with glasses.
Key inclusion criteria (21 listed)
- Age 3 to < 10 years
- Subjects and their parent/guardian speak and understand English adequately to complete the study protocol and give informed consent. Subjects have the ability to adhere to the study visit schedule.
- All refractive error measures below will be determined by cycloplegic retinoscopy by one of the study investigators during the comprehensive eye exam. Measures are in minus cylinder spectacle prescription format.
- Best-corrected visual acuity of <20/30 each eye.
- For hypermetropia:
Key exclusion criteria (5 listed)
- History of spectacle wear
- Previous treatment for amblyopia
- Active amblyopia treatment planned other than spectacles at enrollment
- Prior intraocular or refractive surgery
- Ocular or systemic abnormalities that the examining investigator deems could impact prognosis for visual improvement. Examples could include birth history that may have affected brain development, extremely low birth weight (<1.5 lbs), seizure disorders, cerebral palsy, optic nerve hypoplasia, cranial nerve palsy. Examples that would usually not exclude are off axis media opacity, low birth weight (2.0-3.5 lbs) without complication, mild limitation of extraocular muscle. Cognitive impairment that prohibits accurate data collection
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 |
|---|---|---|
| Prescription glasses for bilateral amblyopiaCorrection of refractive error with prescription glasses both eyes | Other | Bilateral Group |
| Prescription glasses for unilateral amblyopiaCorrection of asymmetric refractive errors with lenses | Other | Unilateral Group |
Primary outcome
visual acuity change from the baseline
Time frame: 8 weeks
visual acuity change from the baseline in logMAR
adherence with optical treatment
Time frame: 8 weeks
The adherence recorded with the microsensor will be calculated as a percentage.
Results and safety
The study was stopped early (reason given: Unable to recruit sufficient number of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Stanley Hatch, OD principal investigator
Salus University
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, run by Salus University 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 21 inclusion and 5 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: stopped early, as of the sponsor's last update on 31 Aug 2020. 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?
The study was stopped early (reason given: Unable to recruit sufficient number of subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity change from the baseline (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2020.