AmblyopiaPhase 3NCT00000170
Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia
A Phase 3 study testing Atropine and Eye Patch in people with Amblyopia, run by Jaeb Center for Health Research at 1 site in United States.
Trial summary
To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy To develop more precise estimates of the success rates of amblyopia treatment To identify factors… Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Atropine and Eye Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Aug 2013
- Phase
- Phase 3
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must be 7 years old or younger with amblyopia due to strabismus or anisometropia
- Visual acuity in the amblyopic eye must be between 20/40 and 20/100
- Visual acuity in the sound eye or 20/40 or better
- At least 3 lines of acuity difference between the two eyes
Who cannot join
- More than two months of amblyopia therapy in the past two years
- Myopia (more than -0.50 D)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilmer Eye Institute
Baltimore, Maryland, 21287-9028
About this study
Official title: Amblyopia Treatment Study: Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia
- To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy
- To develop more precise estimates of the success rates of amblyopia treatment
- To identify factors that may be associated with successful treatment of amblyopia
- To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available
Extended Follow up of Study Patients
- Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years.
- Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
Read the detailed description
Amblyopia, or lazy eye, is the most common cause of visual impairment in children and often persists in adulthood. It is reported to be the leading cause of vision loss in one eye in the 20-70 year old age group, with a prevalence of 1-4 percent in various studies, indicating that both improved means of detection and treatment are needed.
Most of the available data on the natural history of amblyopia and success rates of its treatment with either patching or drug therapy are retrospective and uncontrolled. Despite the common occurrence of amblyopia, there is little quality data on treatment of this condition. Thus, there is much to be learned about the course of treated amblyopia, to provide more precise estimates of success rates and to identify factors that may be associated with successful and unsuccessful treatment.
Amblyopia, when diagnosed in children, is usually treated with occlusion (patching) of the sound eye. Occlusion therapy is subject to problems of compliance, due to the child's dislike of wearing a patch for visual, skin irritation, and social/psychological reasons. There is evidence that compliance may be one of, if not, the most important determinant of success of amblyopia therapy.
An alternative treatment, drug therapy with a cycloplegic drug (atropine) that dilates the pupils and blurs the image seen by the sound eye, has been known for almost a century. This method has been widely used for the management of occlusion treatment failures and for maintenance therapy. However, it has seen little use as a primary treatment for amblyopia. Clinical experience has found that it has a high acceptability to patients and parents, and hence high compliance. In addition to its acceptability, pharmacologic therapy has the known advantage over occlusion of providing a wider visual field with both eyes, which may have safety and other functional implications. There is also clinical and laboratory evidence suggesting that drug therapy may maintain and improve the ability to see with both eyes (binocularity).
Available data suggest that the success rate with drug therapy is as good as, if not better than, the success rate with occlusion therapy for mild to moderate degrees of amblyopia. If this is true, for many children with amblyopia, drug therapy may be the preferred initial therapy since it appears to be more readily accepted by the children and parents. Despite data to support the use of drug therapy as a primary therapy for amblyopia, it has gained only limited use among pediatric ophthalmologists. A definitive study comparing the outcomes from occlusion therapy and drug therapy is justified in order to determine if new practice guidelines for treatment of amblyopia are needed.
Regardless of whether the trial determines that one therapeutic approach is better than the other, the data that are collected will provide valuable information about the course of amblyopia treatment that is not presently available. The study also is expected to provide data that will help to determine whether factors such as age, refractive status, cause of amblyopia, or fixation pattern should be considered in determining which procedure is best for a given patient.
Extended Follow-up of Study Patients
The extended follow up study consists of annual visits prior to age 10, followed by a visit at age 10 years and a visit at age 15 years. There is no amblyopia treatment that is required during the extended follow up period.
- Conditions
- Amblyopia
- Being tested
- Atropine, Eye Patch
- Keywords
- Amblyopia, patching, atropine
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Atropine
Eye PatchDevice
Patching
| Study group | Role | What they receive |
|---|---|---|
| Patching | Active comparator | Not described Receives: Device: Eye Patch |
| Atropine | Active comparator | Atropine Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity in the amblyopic eye
Measured: 6 months
Secondary outcomes (3)
Visual acuity in the amblyopic eye
Measured: 24 months
Extended Follow-up: (Primary) To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years
Measured: age 10 years and age 15 years
Extended Follow-up: To determine whether the long-term visual acuity outcome at age 10 yrs and age 15 yrs differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
Measured: age 10 years and age 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 1999 (estimated)
- Study startApr 1999
- Primary completionNov 2001
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Michael X. Repka, M.D., Study chair, Wilmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000170
- Sponsor's protocol ID
- NEI-73
- Other IDs
- 2U10EY011751, 5U10EY011751
- Status last verified
- Mar 2014
- First submitted
- 23 Sep 1999
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pediatric Eye Disease Investigator Group.. A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2002 Mar;120(3):268-78. doi: 10.1001/archopht.120.3.268.
PubMed 11879129Pediatric Eye Disease Investigator Group. The clinical profile of moderate amblyopia in children younger than 7 years. Arch Ophthalmol. 2002 Mar;120(3):281-7.
PubMed 11879130Cole SR, Beck RW, Moke PS, Celano MP, Drews CD, Repka MX, Holmes JM, Birch EE, Kraker RT, Kip KE; Pediatric Eye Disease Investigator Group. The Amblyopia Treatment Index. J AAPOS. 2001 Aug;5(4):250-4. doi: 10.1067/mpa.2001.117097.
PubMed 11507585Holmes JM, Beck RW, Repka MX, Leske DA, Kraker RT, Blair RC, Moke PS, Birch EE, Saunders RA, Hertle RW, Quinn GE, Simons KA, Miller JM; Pediatric Eye Disease Investigator Group. The amblyopia treatment study visual acuity testing protocol. Arch Ophthalmol. 2001 Sep;119(9):1345-53. doi: 10.1001/archopht.119.9.1345.
PubMed 11545641Pediatric Eye Disease Investigator Group. A comparison of atropine and patching treatments for moderate amblyopia by patient age, cause of amblyopia, depth of amblyopia, and other factors. Ophthalmology. 2003 Aug;110(8):1632-7; discussion 1637-8. doi: 10.1016/S0161-6420(03)00500-1.
PubMed 12917184Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with atropine in children: experience of the amblyopia treatment study. Am J Ophthalmol. 2003 Oct;136(4):630-9. doi: 10.1016/s0002-9394(03)00458-6.
PubMed 14516802Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with patching in children: experience of the amblyopia treatment study. Am J Ophthalmol. 2003 Oct;136(4):620-9. doi: 10.1016/s0002-9394(03)00392-1.
PubMed 14516801Holmes JM, Beck RW, Kraker RT, Cole SR, Repka MX, Birch EE, Felius J, Christiansen SP, Coats DK, Kulp MT; Pediatric Eye Disease Investigator Group. Impact of patching and atropine treatment on the child and family in the amblyopia treatment study. Arch Ophthalmol. 2003 Nov;121(11):1625-32. doi: 10.1001/archopht.121.11.1625.
PubMed 14609923Repka MX, Wallace DK, Beck RW, Kraker RT, Birch EE, Cotter SA, Donahue S, Everett DF, Hertle RW, Holmes JM, Quinn GE, Scheiman MM, Weakley DR; Pediatric Eye Disease Investigator Group. Two-year follow-up of a 6-month randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2005 Feb;123(2):149-57. doi: 10.1001/archopht.123.2.149.
PubMed 15710809Repka MX, Holmes JM, Melia BM, Beck RW, Gearinger MD, Tamkins SM, Wheeler DT; Pediatric Eye Disease Investigator Group. The effect of amblyopia therapy on ocular alignment. J AAPOS. 2005 Dec;9(6):542-5. doi: 10.1016/j.jaapos.2005.07.009.
PubMed 16414520Repka MX, Melia M, Eibschitz-Tsimhoni M, London R, Magoon E; Pediatric Eye Disease Investigator Group. The effect on refractive error of unilateral atropine as compared with patching for the treatment of amblyopia. J AAPOS. 2007 Jun;11(3):300-2. doi: 10.1016/j.jaapos.2006.09.017.
PubMed 17572346Pediatric Eye Disease Investigator Group; Repka MX, Kraker RT, Beck RW, Holmes JM, Cotter SA, Birch EE, Astle WF, Chandler DL, Felius J, Arnold RW, Tien DR, Glaser SR. A randomized trial of atropine vs patching for treatment of moderate amblyopia: follow-up at age 10 years. Arch Ophthalmol. 2008 Aug;126(8):1039-44. doi: 10.1001/archopht.126.8.1039.
PubMed 18695096Repka MX, Kraker RT, Beck RW, Cotter SA, Holmes JM, Arnold RW, Astle WF, Sala NA, Tien DR; Pediatric Eye Disease Investigator Group. Monocular oral reading performance after amblyopia treatment in children. Am J Ophthalmol. 2008 Dec;146(6):942-7. doi: 10.1016/j.ajo.2008.06.022. Epub 2008 Aug 16.
PubMed 18708179Repka MX, Kraker RT, Holmes JM, Summers AI, Glaser SR, Barnhardt CN, Tien DR; Pediatric Eye Disease Investigator Group. Atropine vs patching for treatment of moderate amblyopia: follow-up at 15 years of age of a randomized clinical trial. JAMA Ophthalmol. 2014 Jul;132(7):799-805. doi: 10.1001/jamaophthalmol.2014.392.
PubMed 24789375Kulp MT, Foster NC, Holmes JM, Kraker RT, Melia BM, Repka MX, Tien DR; Pediatric Eye Disease Investigator Group. Effect of ocular alignment on emmetropization in children <10 years with amblyopia. Am J Ophthalmol. 2012 Aug;154(2):297-302.e1. doi: 10.1016/j.ajo.2012.02.035. Epub 2012 May 23.
PubMed 22633344
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amblyopia Treatment Study: Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia
- ClinicalTrials.gov ID
- NCT00000170
- Acronym / sponsor ID
- NEI-73
- Conditions
- Amblyopia
- Keywords
- Amblyopia, patching, atropine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Apr 1999
- Primary completion
- Nov 2001 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 Sep 1999 (estimated)
- 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.
- To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy
- To develop more precise estimates of the success rates of amblyopia treatment
- To identify factors that may be associated with successful treatment of amblyopia
- To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available
Extended Follow up of Study Patients
- Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years.
- Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
Detailed description
Amblyopia, or lazy eye, is the most common cause of visual impairment in children and often persists in adulthood. It is reported to be the leading cause of vision loss in one eye in the 20-70 year old age group, with a prevalence of 1-4 percent in various studies, indicating that both improved means of detection and treatment are needed.
Most of the available data on the natural history of amblyopia and success rates of its treatment with either patching or drug therapy are retrospective and uncontrolled. Despite the common occurrence of amblyopia, there is little quality data on treatment of this condition. Thus, there is much to be learned about the course of treated amblyopia, to provide more precise estimates of success rates and to identify factors that may be associated with successful and unsuccessful treatment.
Amblyopia, when diagnosed in children, is usually treated with occlusion (patching) of the sound eye. Occlusion therapy is subject to problems of compliance, due to the child's dislike of wearing a patch for visual, skin irritation, and social/psychological reasons. There is evidence that compliance may be one of, if not, the most important determinant of success of amblyopia therapy.
An alternative treatment, drug therapy with a cycloplegic drug (atropine) that dilates the pupils and blurs the image seen by the sound eye, has been known for almost a century. This method has been widely used for the management of occlusion treatment failures and for maintenance therapy. However, it has seen little use as a primary treatment for amblyopia. Clinical experience has found that it has a high acceptability to patients and parents, and hence high compliance. In addition to its acceptability, pharmacologic therapy has the known advantage over occlusion of providing a wider visual field with both eyes, which may have safety and other functional implications. There is also clinical and laboratory evidence suggesting that drug therapy may maintain and improve the ability to see with both eyes (binocularity).
Available data suggest that the success rate with drug therapy is as good as, if not better than, the success rate with occlusion therapy for mild to moderate degrees of amblyopia. If this is true, for many children with amblyopia, drug therapy may be the preferred initial therapy since it appears to be more readily accepted by the children and parents. Despite data to support the use of drug therapy as a primary therapy for amblyopia, it has gained only limited use among pediatric ophthalmologists. A definitive study comparing the outcomes from occlusion therapy and drug therapy is justified in order to determine if new practice guidelines for treatment of amblyopia are needed.
Regardless of whether the trial determines that one therapeutic approach is better than the other, the data that are collected will provide valuable information about the course of amblyopia treatment that is not presently available. The study also is expected to provide data that will help to determine whether factors such as age, refractive status, cause of amblyopia, or fixation pattern should be considered in determining which procedure is best for a given patient.
Extended Follow-up of Study Patients
The extended follow up study consists of annual visits prior to age 10, followed by a visit at age 10 years and a visit at age 15 years. There is no amblyopia treatment that is required during the extended follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patching | Active comparator | Device: Eye Patch |
| Atropine | Active comparator | Drug: AtropineAtropine |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients must be 7 years old or younger with amblyopia due to strabismus or anisometropia
- Visual acuity in the amblyopic eye must be between 20/40 and 20/100
- Visual acuity in the sound eye or 20/40 or better
- At least 3 lines of acuity difference between the two eyes
Key exclusion criteria (2 listed)
- More than two months of amblyopia therapy in the past two years
- Myopia (more than -0.50 D)
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 |
|---|---|---|
| AtropineAtropine | Drug | Atropine |
| Eye PatchPatching | Device | Patching |
Primary outcome
Visual acuity in the amblyopic eye
Time frame: 6 months
3 secondary outcomes
Visual acuity in the amblyopic eye
Time frame: 24 months
Extended Follow-up: (Primary) To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years
Time frame: age 10 years and age 15 years
Extended Follow-up: To determine whether the long-term visual acuity outcome at age 10 yrs and age 15 yrs differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care
Time frame: age 10 years and age 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Background: PubMed 11879129Pediatric Eye Disease Investigator Group.. A randomized trial of atropine vs. patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2002 Mar;120(3):268-78. doi: 10.1001/archopht.120.3.268.
- Background: PubMed 11879130Pediatric Eye Disease Investigator Group. The clinical profile of moderate amblyopia in children younger than 7 years. Arch Ophthalmol. 2002 Mar;120(3):281-7.
- Background: PubMed 11507585Cole SR, Beck RW, Moke PS, Celano MP, Drews CD, Repka MX, Holmes JM, Birch EE, Kraker RT, Kip KE; Pediatric Eye Disease Investigator Group. The Amblyopia Treatment Index. J AAPOS. 2001 Aug;5(4):250-4. doi: 10.1067/mpa.2001.117097.
- Background: PubMed 11545641Holmes JM, Beck RW, Repka MX, Leske DA, Kraker RT, Blair RC, Moke PS, Birch EE, Saunders RA, Hertle RW, Quinn GE, Simons KA, Miller JM; Pediatric Eye Disease Investigator Group. The amblyopia treatment study visual acuity testing protocol. Arch Ophthalmol. 2001 Sep;119(9):1345-53. doi: 10.1001/archopht.119.9.1345.
- Background: PubMed 12917184Pediatric Eye Disease Investigator Group. A comparison of atropine and patching treatments for moderate amblyopia by patient age, cause of amblyopia, depth of amblyopia, and other factors. Ophthalmology. 2003 Aug;110(8):1632-7; discussion 1637-8. doi: 10.1016/S0161-6420(03)00500-1.
- Background: PubMed 14516802Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with atropine in children: experience of the amblyopia treatment study. Am J Ophthalmol. 2003 Oct;136(4):630-9. doi: 10.1016/s0002-9394(03)00458-6.
- Background: PubMed 14516801Pediatric Eye Disease Investigator Group. The course of moderate amblyopia treated with patching in children: experience of the amblyopia treatment study. Am J Ophthalmol. 2003 Oct;136(4):620-9. doi: 10.1016/s0002-9394(03)00392-1.
- Background: PubMed 14609923Holmes JM, Beck RW, Kraker RT, Cole SR, Repka MX, Birch EE, Felius J, Christiansen SP, Coats DK, Kulp MT; Pediatric Eye Disease Investigator Group. Impact of patching and atropine treatment on the child and family in the amblyopia treatment study. Arch Ophthalmol. 2003 Nov;121(11):1625-32. doi: 10.1001/archopht.121.11.1625.
- Background: PubMed 15710809Repka MX, Wallace DK, Beck RW, Kraker RT, Birch EE, Cotter SA, Donahue S, Everett DF, Hertle RW, Holmes JM, Quinn GE, Scheiman MM, Weakley DR; Pediatric Eye Disease Investigator Group. Two-year follow-up of a 6-month randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol. 2005 Feb;123(2):149-57. doi: 10.1001/archopht.123.2.149.
- Background: PubMed 16414520Repka MX, Holmes JM, Melia BM, Beck RW, Gearinger MD, Tamkins SM, Wheeler DT; Pediatric Eye Disease Investigator Group. The effect of amblyopia therapy on ocular alignment. J AAPOS. 2005 Dec;9(6):542-5. doi: 10.1016/j.jaapos.2005.07.009.
- Background: PubMed 17572346Repka MX, Melia M, Eibschitz-Tsimhoni M, London R, Magoon E; Pediatric Eye Disease Investigator Group. The effect on refractive error of unilateral atropine as compared with patching for the treatment of amblyopia. J AAPOS. 2007 Jun;11(3):300-2. doi: 10.1016/j.jaapos.2006.09.017.
- Background: PubMed 18695096Pediatric Eye Disease Investigator Group; Repka MX, Kraker RT, Beck RW, Holmes JM, Cotter SA, Birch EE, Astle WF, Chandler DL, Felius J, Arnold RW, Tien DR, Glaser SR. A randomized trial of atropine vs patching for treatment of moderate amblyopia: follow-up at age 10 years. Arch Ophthalmol. 2008 Aug;126(8):1039-44. doi: 10.1001/archopht.126.8.1039.
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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.
Michael X. Repka, M.D. study chair
Wilmer Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atropine and Eye Patch 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 4 inclusion and 2 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 6 Mar 2014. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in the amblyopic eye (time frame: 6 months). 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 NCT00000170, which also lists 16 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 6 Mar 2014.