MyopiaPhase 2NCT00317551
Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development
A Phase 2 study testing Vision training in people with Myopia, run by Anglia Ruskin University at 1 site in United Kingdom.
Trial summary
We have identified focussing problems related to myopia getting worse. Our trial uses optical and orthoptic interventions that correct the focussing problems to see if this retards myopia progression. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Vision training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2005to not given
- Phase
- Phase 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 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Best corrected visual acuity of 6/5 in each eye
- Myopia in each meridian of at least 0.50 D
- Willingness to give consent
- Willingness to undertake any treatment option
Who cannot join
- History of systemic/ocular pathology
- History of any ocular surgery
- More than 10D of myopia
- Astigmatism more than 1.00 D
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Anglia Ruskin University
Cambridge, Cambridgeshire, CB1 1PT
About this study
Official title: Accommodation Training and Aberration Control in Myopia Development
We have identified focussing problems related to myopia getting worse. Our trial uses optical and orthoptic interventions that correct the focussing problems to see if this retards myopia progression.
Read the detailed description
Myopia is a burgeoning health and social problem. Currently there is no acceptable clinical treatment that prevents progression. This study is a double masked placebo controlled block randomized clinical trial of two interventions, to treat accommodative factors we have identified as being significantly correlated to myopia progression (rather than to the presence of myopia). We have shown that the interventions normalise the accommodative factors, and this trial examines the effect of these interventions on myopia progression.
- Conditions
- Myopia
- Being tested
- Aberration controlled contact lens, Vision training
- Keywords
- Aberration control, Accommodative facility, Accommodative response, Peripheral refraction, Accommodative convergence to accommodation ratio
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aberration controlled contact lensDevice
Vision trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in refractive error in myopia in 6 monthly intervals for 2 years
Change in axial length in 6 monthly intervals for 2 years
Age effects on refractive changes over 2 years
Secondary outcomes (4)
Change in accommodative response in 6 monthly intervals for 2 years
Change in accommodative facility in 6 monthly intervals for 2 years
Change in peripheral refraction in 6 monthly intervals for 2 years
Change in AC/A ratio in 6 monthly intervals for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Collaborators
- Vision CRC
- Investigators
- Daniel J O'Leary, PhD, Study director, University of Wales Institute CardiffPeter M Allen, PhD, Study chair, Anglia Ruskin UniversityHema Radhakrishnan, PhD, Principal investigator, University of ManchesterRichard I Calver, PhD, Principal investigator, Anglia Ruskin UniversityEbi P Osuobeni, PhD, Principal investigator, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317551
- Sponsor's protocol ID
- VisionCRC-ARU
- Status last verified
- Dec 2005
- First submitted
- 21 Apr 2006
- Last updated
- 17 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accommodation Training and Aberration Control in Myopia Development
- ClinicalTrials.gov ID
- NCT00317551
- Acronym / sponsor ID
- VisionCRC-ARU
- Conditions
- Myopia
- Keywords
- Aberration control, Accommodative facility, Accommodative response, Peripheral refraction, Accommodative convergence to accommodation ratio
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Collaborators
- Vision CRC
- Study start
- Apr 2005
- First posted
- 25 Apr 2006 (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.
We have identified focussing problems related to myopia getting worse. Our trial uses optical and orthoptic interventions that correct the focussing problems to see if this retards myopia progression.
Detailed description
Myopia is a burgeoning health and social problem. Currently there is no acceptable clinical treatment that prevents progression. This study is a double masked placebo controlled block randomized clinical trial of two interventions, to treat accommodative factors we have identified as being significantly correlated to myopia progression (rather than to the presence of myopia). We have shown that the interventions normalise the accommodative factors, and this trial examines the effect of these interventions on myopia progression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Best corrected visual acuity of 6/5 in each eye
- Myopia in each meridian of at least 0.50 D
- Willingness to give consent
- Willingness to undertake any treatment option
Key exclusion criteria (4 listed)
- History of systemic/ocular pathology
- History of any ocular surgery
- More than 10D of myopia
- Astigmatism more than 1.00 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 |
|---|---|---|
| Aberration controlled contact lens | Device | – |
| Vision training | Behavioural | – |
Primary outcome
Change in refractive error in myopia in 6 monthly intervals for 2 years
Change in axial length in 6 monthly intervals for 2 years
Age effects on refractive changes over 2 years
4 secondary outcomes
Change in accommodative response in 6 monthly intervals for 2 years
Change in accommodative facility in 6 monthly intervals for 2 years
Change in peripheral refraction in 6 monthly intervals for 2 years
Change in AC/A ratio in 6 monthly intervals for 2 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 17 Oct 2006.
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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.
Daniel J O'Leary, PhD study director
University of Wales Institute Cardiff
Peter M Allen, PhD study chair
Anglia Ruskin University
Hema Radhakrishnan, PhD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vision training in people with Myopia, run by Anglia Ruskin University at 1 site in United Kingdom.
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 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 17 Oct 2006. 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 Kingdom. 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 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?
Change in refractive error in myopia in 6 monthly intervals for 2 years. The study lists 3 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 17 Oct 2006.