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Cambridge Anti-Myopia Trial: Accommodation Training and Aberration Control in Myopia Development

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00317551
First Posted: April 25, 2006
Last Update Posted: October 17, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vision CRC
Information provided by:
Anglia Ruskin University
  Purpose
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.

Condition Intervention Phase
Myopia Device: Aberration controlled contact lens Behavioral: Vision training Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Accommodation Training and Aberration Control in Myopia Development

Further study details as provided by Anglia Ruskin University:

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

Estimated Enrollment: 200
Study Start Date: April 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317551


Locations
United Kingdom
Anglia Ruskin University
Cambridge, Cambridgeshire, United Kingdom, CB1 1PT
Sponsors and Collaborators
Anglia Ruskin University
Vision CRC
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
  More Information

ClinicalTrials.gov Identifier: NCT00317551     History of Changes
Other Study ID Numbers: VisionCRC-ARU
First Submitted: April 21, 2006
First Posted: April 25, 2006
Last Update Posted: October 17, 2006
Last Verified: December 2005

Keywords provided by Anglia Ruskin University:
Aberration control
Accommodative facility
Accommodative response
Peripheral refraction
Accommodative convergence to accommodation ratio

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases