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

Myopia Clinical Trial

Official title:

Accommodation Training and Aberration Control in Myopia Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317551
• Other study ID #: VisionCRC-ARU
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2006
• Last updated: October 16, 2006
• Start date: April 2005

Study information

• Verified date: December 2005
• Source: Anglia Ruskin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 21 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Aberration controlled contact lens

Behavioral:
• Vision training

Locations

Country	Name	City	State
United Kingdom	Anglia Ruskin University	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Anglia Ruskin University	Vision CRC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in refractive error in myopia in 6 monthly intervals for 2 years
Primary	Change in axial length in 6 monthly intervals for 2 years
Primary	Age effects on refractive changes over 2 years
Secondary	Change in accommodative response in 6 monthly intervals for 2 years
Secondary	Change in accommodative facility in 6 monthly intervals for 2 years
Secondary	Change in peripheral refraction in 6 monthly intervals for 2 years
Secondary	Change in AC/A ratio in 6 monthly intervals for 2 years