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

This study has been completed.
Sponsor:
Collaborator:
Vision CRC
Information provided by:
Anglia Ruskin University
ClinicalTrials.gov Identifier:
NCT00317551
First received: April 21, 2006
Last updated: October 16, 2006
Last verified: December 2005
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00317551     History of Changes
Other Study ID Numbers: VisionCRC-ARU
Study First Received: April 21, 2006
Last Updated: October 16, 2006
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 18, 2014