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

Phase 2

Completed

• Conditions: Myopia

• Registration Number: NCT00317551
• Lead Sponsor: Anglia Ruskin University

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.

Study Timeline

• Study Start: 2005-04
• Status Verified: 2005-12
• Study First Submitted: 2006-04-21
• Study First Submitted QC: 2006-04-21
• Study First Posted: 2006-04-25
• Last Update Submitted: 2006-10-16
• Last Update Posted: 2006-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Anglia Ruskin University; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom