AmblyopiaPhase 1/2NCT00970554
Effectiveness of Telescopic Magnification in the Treatment of Amblyopia
A Phase 1/2 study testing Patching and Telescopic magnification in people with Amblyopia, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Amblyopia is a visual impairment of one eye that results from disuse of that eye during early brain development. The standard treatment for amblyopia consists of patching or pharmacological penalization of the sound eye. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Patching and Telescopic magnification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2007to May 2009
- Phase
- Phase 1/2
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 4-17 years
- Strabismic, refractive (anisometropic), isometropic or mixed mechanism amblyopia
- Strabismic amblyopia is defined as amblyopia (1) in the presence of either an inability to maintain parallel visual axes (heterotropia) at distance or near fixation or both, or a history of strabismus surgery (or botulinum injection), and (2) in the absence of refractive error meeting the criteria below for mixed mechanism amblyopia
- Refractive/Anisometropic amblyopia is defined as amblyopia in the presence of a difference in refractive error between the two eyes (anisometropia) of ≥0.5 diopter (D) of spherical equivalent or ≥1.5D of difference in astigmatism in any meridian, with no measurable heterophoria at distance or near fixation, which persisted after 12 weeks of spectacle correction
- Isometropic amblyopia is defined as amblyopia in the presence a refractive error ≥5.0D of spherical equivalent in both eyes, but not meeting the criteria of anisometropic amblyopia
- Mixed mechanism strabismic and refractive amblyopia is defined as the presence of both strabismic and anisometropic types of amblyopia
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- Ability to read the ETDRS letter chart
- Visual acuity between 0.3 and 1.3 logMAR (i.e., between 20/40 and 20/400) in the amblyopic eye
- Visual acuity of 0.3 logMAR (i.e., 20/40) or better in the sound eye
- Interocular acuity difference ≥0.3 logMAR
- Appropriate refractive error correction for at least 12 weeks
Who cannot join
- Presence of an ocular cause of reduced visual acuity
- Myopia with a spherical equivalent of -6.0D or more, due to the likely presence of pathological myopia
- Prior intraocular surgery
- Known skin reaction to patch or bandage adhesive
Trial locations and contacts
1 site in 1 country.
About this study
Amblyopia is a visual impairment of one eye that results from disuse of that eye during early brain development. The standard treatment for amblyopia consists of patching or pharmacological penalization of the sound eye. Unfortunately, approximately 50% of amblyopic children do not respond to these therapies, with poor compliance being a major factor in treatment failure. One new treatment strategy involves patching the sound eye while using a telescopic device on the amblyopic eye to magnify the images formed in the amblyopic eye. Children were randomized to receive either daily patching of the sound eye for 30 minutes only (patching only group), or daily patching of the sound eye for 30 minutes plus simultaneous use of a telescopic device by the amblyopic eye during patching (patching plus telescope group).
Read the detailed description
The goal of the present investigation was to conduct a prospective randomized clinical study to further evaluate the effectiveness of telescopic magnification plus patching vs patching alone on different types of amblyopia in patients who had failed previous treatment.
- Conditions
- Amblyopia
- Being tested
- Patching, Telescopic magnification
- Keywords
- Amblyopia, Telescopic magnification, Patching
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatchingOther
Patching of the sound eye for 30 minutes a day for 17 weeks.
Telescopic magnificationOther
Patching of the sound eye plus simultaneous use of a telescopic device by the amblyopic eye for 30 minutes a day for 17 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patching only | Active comparator | Not described Receives: Other: Patching |
| Patching plus telescope group | Experimental | Not described Receives: Other: Telescopic magnification |
What is being measured
The primary outcome is the main question the study is designed to answer.
The best corrected logMAR visual acuity score of the amblyopic eye.
Measured: 17 weeks
Secondary outcomes (1)
Visual acuity of at least 0.2 logMAR (20/30) and/or improvement of at least 0.2 logMAR from baseline in the amblyopic eye.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startDec 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Hospital for Sick ChildrenThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Wong, The Hospital for Sick Children
- Investigators
- Agnes Wong, MD, Principal investigator, The Hospital for Sick Children, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970554
- Sponsor's protocol ID
- 1000011712
- Status last verified
- Aug 2013
- First submitted
- 1 Sep 2009
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wu J, Nazemi F, Schofield J, Mirabella G, Wong AM. Effectiveness of telescopic magnification in the treatment of amblyopia: a pilot study. Arch Ophthalmol. 2010 Mar;128(3):297-302. doi: 10.1001/archophthalmol.2009.400.
PubMed 20212198
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telescopic Magnification in the Treatment of Amblyopia
- ClinicalTrials.gov ID
- NCT00970554
- Acronym / sponsor ID
- 1000011712
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Telescopic magnification, Patching
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Sep 2009 (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.
Amblyopia is a visual impairment of one eye that results from disuse of that eye during early brain development. The standard treatment for amblyopia consists of patching or pharmacological penalization of the sound eye. Unfortunately, approximately 50% of amblyopic children do not respond to these therapies, with poor compliance being a major factor in treatment failure. One new treatment strategy involves patching the sound eye while using a telescopic device on the amblyopic eye to magnify the images formed in the amblyopic eye. Children were randomized to receive either daily patching of the sound eye for 30 minutes only (patching only group), or daily patching of the sound eye for 30 minutes plus simultaneous use of a telescopic device by the amblyopic eye during patching (patching plus telescope group).
Detailed description
The goal of the present investigation was to conduct a prospective randomized clinical study to further evaluate the effectiveness of telescopic magnification plus patching vs patching alone on different types of amblyopia in patients who had failed previous treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patching only | Active comparator | Other: Patching |
| Patching plus telescope group | Experimental | Other: Telescopic magnification |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Aged 4-17 years
- Strabismic, refractive (anisometropic), isometropic or mixed mechanism amblyopia
- Ability to read the ETDRS letter chart
- Visual acuity between 0.3 and 1.3 logMAR (i.e., between 20/40 and 20/400) in the amblyopic eye
- Visual acuity of 0.3 logMAR (i.e., 20/40) or better in the sound eye
Key exclusion criteria (4 listed)
- Presence of an ocular cause of reduced visual acuity
- Myopia with a spherical equivalent of -6.0D or more, due to the likely presence of pathological myopia
- Prior intraocular surgery
- Known skin reaction to patch or bandage adhesive
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 |
|---|---|---|
| PatchingPatching of the sound eye for 30 minutes a day for 17 weeks. | Other | Patching only |
| Telescopic magnificationPatching of the sound eye plus simultaneous use of a telescopic device by the amblyopic eye for 30 minutes a day for 17 weeks. | Other | Patching plus telescope group |
Primary outcome
The best corrected logMAR visual acuity score of the amblyopic eye.
Time frame: 17 weeks
1 secondary outcome
Visual acuity of at least 0.2 logMAR (20/30) and/or improvement of at least 0.2 logMAR from baseline in the amblyopic eye.
Time frame: 17 weeks
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 27 Aug 2013.
- Derived from this study: PubMed 20212198Wu J, Nazemi F, Schofield J, Mirabella G, Wong AM. Effectiveness of telescopic magnification in the treatment of amblyopia: a pilot study. Arch Ophthalmol. 2010 Mar;128(3):297-302. doi: 10.1001/archophthalmol.2009.400.
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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.
Agnes Wong, MD principal investigator
The Hospital for Sick Children, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Patching and Telescopic magnification in people with Amblyopia, run by The Hospital for Sick Children at 1 site in Canada.
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 11 inclusion and 4 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 27 Aug 2013. 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 Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The best corrected logMAR visual acuity score of the amblyopic eye. (time frame: 17 weeks). 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 NCT00970554, 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 27 Aug 2013.