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

  • United Kingdom
    • 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

Anglia Ruskin University

Collaborators

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

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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