- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00317551
Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development
October 16, 2006 updated by: Anglia Ruskin University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB1 1PT
- Anglia Ruskin University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of systemic/ocular pathology
- History of any ocular surgery
- More than 10D of myopia
- Astigmatism more than 1.00 D
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Daniel J O'Leary, PhD, University of Wales Institute Cardiff
- Study Chair: Peter M Allen, PhD, Anglia Ruskin University
- Principal Investigator: Hema Radhakrishnan, PhD, University of Manchester
- Principal Investigator: Richard I Calver, PhD, Anglia Ruskin University
- Principal Investigator: Ebi P Osuobeni, PhD, Anglia Ruskin University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Registration Dates
First Submitted
April 21, 2006
First Submitted That Met QC Criteria
April 21, 2006
First Posted (Estimate)
April 25, 2006
Study Record Updates
Last Update Posted (Estimate)
October 17, 2006
Last Update Submitted That Met QC Criteria
October 16, 2006
Last Verified
December 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VisionCRC-ARU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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