Anisometropic AmblypiaPhase 3NCT00498641
Anisometropia Amblyopia Improved by Perceptual Learning and Patching
A Phase 3 study testing computer program and patching in people with Anisometropic Amblypia, run by Tri-Service General Hospital (TSGH).
Trial summary
To compare the effects of perceptual learning with patching on improving visual acuity and contrast sensitivity in payient with anisometropic amblyopia. Read more about this study
- Who is it for?
- Ages 3 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anisometropic Amblypia
- What is being tested?
- computer program and patching
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jan 2007
- 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 3 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Anisometropia without strabismus
- An interocular acuity difference of at least 0.2 logMAR in children (3-7 years of age) or in older children and adult patients without a history of patching or atropine penalization
- All patients wore their spectacle at least one year
Who cannot join
- A history of prior spectacle correction
- A history of patching or optical penalization
- The existence of an ocular disease that could contribute to decreased visual acuity
- Learning difficulties
- The presence of strabismus
About this study
To compare the effects of perceptual learning with patching on improving visual acuity and contrast sensitivity in payient with anisometropic amblyopia.
Read the detailed description
Patients with anisometropic amblyopia were randomized to patching or perceptual learning group. Corrected amblyopic logMAR visual acuity and contrast sensitivity function were measured at four-weekly intervals until visual acuity stabilized or amblyopia resolved. Improvement in visual acuity, contrast sensitivity, and the resolution of amblyopia were compared between groups.
- Conditions
- Anisometropic Amblypia
- Being tested
- computer program and patching
- Keywords
- perceptual learning, occlusion therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer program and patchingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected amblyopic logMAR visual acuity and contrast sensitivity function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startJan 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anisometropic AmblypiaStudies 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
- Single blind
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Investigators
- Po Chen, MD, Study director, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498641
- Sponsor's protocol ID
- 094-05-0112
- Status last verified
- Jul 2007
- First submitted
- 9 Jul 2007
- Last updated
- 10 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anisometropia Amblyopia Improved by Perceptual Learning and Patching
- ClinicalTrials.gov ID
- NCT00498641
- Acronym / sponsor ID
- 094-05-0112
- Conditions
- Anisometropic Amblypia
- Keywords
- perceptual learning, occlusion therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Jan 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 10 Jul 2007 (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 compare the effects of perceptual learning with patching on improving visual acuity and contrast sensitivity in payient with anisometropic amblyopia.
Detailed description
Patients with anisometropic amblyopia were randomized to patching or perceptual learning group. Corrected amblyopic logMAR visual acuity and contrast sensitivity function were measured at four-weekly intervals until visual acuity stabilized or amblyopia resolved. Improvement in visual acuity, contrast sensitivity, and the resolution of amblyopia were compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 3 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Anisometropia without strabismus
- An interocular acuity difference of at least 0.2 logMAR in children (3-7 years of age) or in older children and adult patients without a history of patching or atropine penalization
- All patients wore their spectacle at least one year
Key exclusion criteria (5 listed)
- A history of prior spectacle correction
- A history of patching or optical penalization
- The existence of an ocular disease that could contribute to decreased visual acuity
- Learning difficulties
- The presence of strabismus
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 |
|---|---|---|
| computer program and patching | Procedure or surgery | – |
Primary outcome
Corrected amblyopic logMAR visual acuity and contrast sensitivity function
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 10 Jul 2007.
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.
Po Chen, MD study director
Tri-Service General Hospital (TSGH)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing computer program and patching in people with Anisometropic Amblypia, run by Tri-Service General Hospital (TSGH).
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 3 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: finished, as of the sponsor's last update on 10 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
Corrected amblyopic logMAR visual acuity and contrast sensitivity function. 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 10 Jul 2007.