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AmblyopiaPhase 3ATS17NCT01190813

Levodopa for the Treatment of Residual Amblyopia

A Phase 3 study testing Levodopa/Carbidopa and Patching in people with Amblyopia, run by Jaeb Center for Health Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of oral levodopa and patching versus oral placebo and patching as treatment for residual amblyopia in children 7 to <13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye. Read more about this study

Who is it for?
Ages 7 to 12 years
Conditions the study is for
Amblyopia
What is being tested?
Levodopa/Carbidopa and Patching
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
139 participants
Where
1 siteUnited States
Study dates
Sep 2010to Apr 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 7 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 7 to 12
  • Amblyopia associated with strabismus, anisometropia, or both
  • Criteria for strabismus: One of the following criteria must be met: Heterotropia at distance and/or near fixation on examination (with or without spectacles); History of strabismus surgery; Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
  • Criteria for anisometropia: One of the following criteria must be met: ≥0.50 D difference between eyes in spherical equivalent; ≥1.50 D difference between eyes in astigmatism in any meridian
  • Visual acuity, measured in each eye (amblyopic eye without cycloplegia) within 7 days prior to enrollment using the E-ETDRS protocol by a study certified visual acuity tester as follows:
  • Visual acuity in the amblyopic eye 18 to 67 letters inclusive (20/50 to 20/400)
Show all 24Show fewer
  • Visual acuity in the fellow eye ≥78 letters (20/25 or better)
  • Current amblyopia treatment (other than spectacles)
  • 12 weeks of at least 2 hours of occlusion per day prescribed for the fellow eye during the immediate pre-enrollment period.
  • While on current treatment, visual acuity has not improved one line (5 letters) or more since a non-study visit at least 6 weeks ago. Both acuity measurements to define no improvement must have been done using the same testing method.
  • Treatment with atropine at any time during this pre-enrollment period is not allowed.
  • Any treatment prior to the current patching episode with stable acuity is acceptable.
  • Spectacle correction (if applicable) for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction that is no more than 6 months old:
  • Requirements for spectacle correction:
  • Spherical equivalent must be within 0.50 D of fully correcting the anisometropia.
  • Hypermetropia of 3.00D or more must be corrected.
  • Hypermetropia must not be under corrected by more than 1.50 D spherical equivalent, and reduction in plus sphere must be symmetric in the two eyes.
  • Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism.
  • Cylinder axis in both eyes is within 6 degrees of the axis in the spectacles when cylinder power is ≥1.00 D.
  • Myopia of amblyopic eye greater than 0.50 D by spherical equivalent must be corrected, and the glasses must not under correct the myopia by more than 0.25 D or overcorrect it by more than 0.50 D.
  • Spectacles meeting above criteria must be worn :until visual acuity in amblyopic eye is stable (defined as 2 consecutive visual acuity measurements by the same testing method at least 4 weeks apart with no improvement of one line (5 letters) or more.
  • Eye examination within 6 months prior to enrollment
  • Parent available for at least one year of follow-up, has access to phone), and willing to be contacted by clinical site and Jaeb Center staff
  • In the investigator's judgment, the subject is likely to comply with prescribed treatment (e.g., no history of poor compliance with patching treatment) and unlikely to continue to improve by using 2 hours of patching per day alone.

Who cannot join

  • Myopia more than -6.00 D (spherical equivalent) in either eye.
  • Current vision therapy or orthoptics
  • Ocular cause for reduced visual acuity
  • nystagmus per se does not exclude the subject if the above visual acuity criteria are met
  • Prior intraocular or refractive surgery
  • History of narrow-angle glaucoma
Show all 22Show fewer
  • Bronchial asthma or severe pulmonary disease
  • Strabismus surgery planned within 26 weeks
  • Known allergy to levodopa or carbidopa
  • History of dystonic reactions
  • Current use of oral iron supplements including multivitamins containing iron during treatment with levodopa-carbidopa
  • Current use of antihypertensive, anti-depressant medications, phenothiazines, butyrophenones, risperidone and isoniazid, non-specific monoamine oxidase inhibitors, or medication for the treatment of attention deficit hyperactivity disorder
  • Known liver disease
  • History of melanoma
  • Known psychological problems
  • Known skin reactions to patch or bandage adhesives
  • Prior levodopa treatment
  • Treatment with topical ophthalmic atropine within the past 12 weeks
  • A physician-prescribed diet high in protein
  • Females who are pregnant, lactating, or intend to become pregnant within the next 34 weeks.
  • A negative urine pregnancy test will be required for all females who have experienced menarche.
  • Requirements regarding pregnancy testing prior to enrollment may be further defined by each individual Institutional Review Board.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wilmer Eye Institute

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Randomized Trial of Levodopa as Treatment for Residual Amblyopia (ATS 17)

The purpose of this study is to evaluate the efficacy and safety of oral levodopa and patching versus oral placebo and patching as treatment for residual amblyopia in children 7 to <13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.

Read the detailed description

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional amblyopia treatment, many older children and teenagers with amblyopia fail to achieve normal visual acuity in the amblyopic eye. In a previous PEDIG study where children 7 to 12 years old were treated with atropine and patching, only 36% of the children with moderate amblyopia and only 23% of the children with severe amblyopia achieved 20/40 or better acuity.

Many clinicians have recognized that conventional therapies with patching and atropine have not been universally successful and have sought alternatives. PEDIG has discussed for several years the problem of residual amblyopia and how the remaining visual acuity deficit could be reduced. A number of research groups have evaluated the short term use of oral levodopa-carbidopa as an adjunct to patching therapy for older children.

Conditions
Amblyopia
Being tested
Levodopa/Carbidopa, Placebo, Patching
Keywords
amblyopia, levodopa
Medical subject headings
Amblyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levodopa/CarbidopaDrug

    Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid

  • PlaceboDrug

    Oral placebo tid

  • PatchingOther

    Two hours of daily patching

Study groups in NCT01190813
Study groupRoleWhat they receive
Levodopa/CarbidopaActive comparatorLevodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid
Receives: Drug: Levodopa/Carbidopa; Other: Patching
PlaceboPlacebo comparatorOral placebo tid
Receives: Drug: Placebo; Other: Patching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distribution of Amblyopic Eye Visual Acuity Change From Baseline

    The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 18 weeks after enrollment

  2. Mean Amblyopic Eye Visual Acuity Change From Baseline

    The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 18 weeks after enrollment

Secondary outcomes (41)

  1. Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 18 Weeks

    Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.

    Measured: 18 weeks after enrollment

  2. Distribution of Amblyopic Eye Visual Acuity at 18 Weeks

    Measured: 18 weeks after enrollment

  3. Mean Amblyopic Eye Visual Acuity at 18 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 18 weeks after enrollment

  4. Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 4 Weeks

    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.

    Measured: 4 weeks after enrollment

  5. Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 10 Weeks

    Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.

    Measured: 10 weeks after enrollment

  6. Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 16 Weeks

    Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.

    Measured: 16 weeks after enrollment

  7. Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 26 Weeks

    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.

    Measured: 26 weeks after enrollment

  8. Amblyopia Resolutionat 4 Weeks

    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.

    Measured: 4 weeks after enrollment

  9. Amblyopia Resolution at 10 Weeks

    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.

    Measured: 10 weeks after enrollment

  10. Amblyopia Resolution at 16 Weeks

    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.

    Measured: 16 weeks after enrollment

  11. Amblyopia Resolution at 18 Weeks

    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.

    Measured: 18 weeks after enrollment

  12. Amblyopia Resolution at 26 Weeks

    Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.

    Measured: 26 weeks after enrollment

  13. Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 4 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 4 weeks after enrollment

  14. Mean Change in Amblyopic Eye Visual Acuity From Baseline at 4 Weeks

    A treatment group comparison of the mean amblyopic eye visual acuity at 4 weeks after enrollment, adjusted for baseline acuity.

    Measured: 4 weeks after enrollment

  15. Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 10 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 10 weeks after enrollment

  16. Mean Change in Amblyopic Eye Visual Acuity From Baseline at 10 Weeks

    A treatment group comparison of the mean amblyopic eye visual acuity at 10 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 10 weeks after enrollment

  17. Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 16 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 16 weeks after enrollment

  18. Mean Change in Amblyopic Eye Visual Acuity From Baseline at 16 Weeks

    A treatment group comparison of the mean amblyopic eye visual acuity at 16 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 16 weeks after enrollment

  19. Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 26 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 26 weeks after enrollment

  20. Mean Change in Amblyopic Eye Visual Acuity From Baseline at 26 Weeks

    A treatment group comparison of the mean amblyopic eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 26 weeks after enrollment

  21. Distribution of Fellow Eye Visual Acuity at 18 Weeks

    Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the mean fellow eye visual acuity at 18 weeks after enrollment, adjusted for baseline acuity.

    Measured: 18 weeks after enrollment

  22. Mean Fellow Eye Visual Acuity at 18 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 18 weeks after enrollment

  23. Distribution of Fellow Eye Visual Acuity Change From Baseline at 18 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 18 weeks after enrollment

  24. Mean Fellow Eye Visual Acuity Change From Baseline at 18 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 18 weeks after enrollment

  25. Mean Child Symptom Survey Score at Enrollment

    A treatment group comparison of symptom survey scores at enrollment. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: At enrollment

  26. Mean Child Symptom Survey Score at 4 Weeks

    A treatment group comparison of symptom survey scores at the 4 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: 4 weeks after enrollment

  27. Mean Child Symptom Survey Score at 10 Weeks

    A treatment group comparison of symptom survey scores at the 10 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: 10 weeks after enrollment

  28. Mean Child Symptom Survey Score at 16 Weeks

    A treatment group comparison of symptom survey scores at the 16 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: 16 weeks after enrollment

  29. Mean Child Symptom Survey Score at 18 Weeks

    A treatment group comparison of symptom survey scores at the primary outcome (18 week) visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: 18 weeks after enrollment

  30. Mean Child Symptom Survey Score at 26 Weeks

    A treatment group comparison of symptom survey scores at the 26 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: 26 weeks after enrollment

  31. Mean Parent Symptom Survey Score at Enrollment

    A treatment group comparison of symptom survey scores at enrollment. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: At enrollment

  32. Mean Parent Symptom Survey Score at 4 Weeks

    A treatment group comparison of symptom survey scores at the 4 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: 4 weeks after enrollment

  33. Mean Parent Symptom Survey Score at 10 Weeks

    A treatment group comparison of symptom survey scores at the 10 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: 10 weeks after enrollment

  34. Mean Parent Symptom Survey Score at 16 Weeks

    A treatment group comparison of symptom survey scores at the 16 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: 16 weeks after enrollment

  35. Mean Parent Symptom Survey Score at 18 Weeks

    A treatment group comparison of symptom survey scores at the primary outcome (18 week) visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: 18 weeks after enrollment

  36. Mean Parent Symptom Survey Score at 26 Weeks

    A treatment group comparison of symptom survey scores at the 26 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).

    Measured: 26 weeks after enrollment

  37. Mean Systemic Adverse Events

    Measured: Enrollment through 26 weeks

  38. Distribution of Fellow Eye Visual Acuity at 26 Weeks

    Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the mean fellow eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity.

    Measured: 26 weeks after enrollment

  39. Mean Fellow Eye Visual Acuity at 26 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 26 weeks after enrollment

  40. Distribution of Fellow Eye Visual Acuity Change From Baseline at 26 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 26 weeks after enrollment

  41. Mean Fellow Eye Visual Acuity Change From Baseline at 26 Weeks

    Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.

    Measured: 26 weeks after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01190813
Sponsor's protocol ID
ATS 17
Other IDs
2U10EY011751
Acronym
ATS17
Status last verified
May 2016
First submitted
17 Aug 2010
Last updated
2 Jun 2016
Data monitoring committee
Yes
Individual data sharing
Yes: A de-identified dataset is available on the PEDIG public website at http://pedig.jaeb.org/Studies.aspx?RecID=196

Publications

  • Pediatric Eye Disease Investigator Group; Repka MX, Kraker RT, Dean TW, Beck RW, Siatkowski RM, Holmes JM, Beauchamp CL, Golden RP, Miller AM, Verderber LC, Wallace DK. A randomized trial of levodopa as treatment for residual amblyopia in older children. Ophthalmology. 2015 May;122(5):874-81. doi: 10.1016/j.ophtha.2015.01.002. Epub 2015 Feb 9.

    PubMed 25676904

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levodopa/Carbidopa and Patching in people with Amblyopia, run by Jaeb Center for Health Research 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 24 inclusion and 22 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: finished, as of the sponsor's last update on 2 Jun 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Distribution of Amblyopic Eye Visual Acuity Change From Baseline (time frame: 18 weeks after enrollment). 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?

On the ClinicalTrials.gov record for NCT01190813, which also lists 1 linked publication.

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 2 Jun 2016.

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