Back to resultsCambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development
Primary Purpose
Myopia
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Aberration controlled contact lens
Vision training
Sponsored by
About this trial
This is an interventional prevention trial for Myopia focused on measuring Aberration control, Accommodative facility, Accommodative response, Peripheral refraction, Accommodative convergence to accommodation ratio
Eligibility Criteria
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
Sites / Locations
- Anglia Ruskin University
Outcomes
Primary Outcome Measures
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
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
Full Information
NCT ID
NCT00317551
First Posted
April 21, 2006
Last Updated
October 16, 2006
Sponsor
Anglia Ruskin University
Collaborators
Vision CRC
1. Study Identification
Unique Protocol Identification Number
NCT00317551
Brief Title
Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development
Official Title
Accommodation Training and Aberration Control in Myopia Development
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Anglia Ruskin University
Collaborators
Vision CRC
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Aberration control, Accommodative facility, Accommodative response, Peripheral refraction, Accommodative convergence to accommodation ratio
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Aberration controlled contact lens
Intervention Type
Behavioral
Intervention Name(s)
Vision training
Primary Outcome Measure Information:
Title
Change in refractive error in myopia in 6 monthly intervals for 2 years
Title
Change in axial length in 6 monthly intervals for 2 years
Title
Age effects on refractive changes over 2 years
Secondary Outcome Measure Information:
Title
Change in accommodative response in 6 monthly intervals for 2 years
Title
Change in accommodative facility in 6 monthly intervals for 2 years
Title
Change in peripheral refraction in 6 monthly intervals for 2 years
Title
Change in AC/A ratio in 6 monthly intervals for 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J O'Leary, PhD
Organizational Affiliation
University of Wales Institute Cardiff
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter M Allen, PhD
Organizational Affiliation
Anglia Ruskin University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hema Radhakrishnan, PhD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard I Calver, PhD
Organizational Affiliation
Anglia Ruskin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ebi P Osuobeni, PhD
Organizational Affiliation
Anglia Ruskin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anglia Ruskin University
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB1 1PT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development
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