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

• Sponsor: Anglia Ruskin University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00317551
• Collaborator: Vision CRC (Other)
• Enrollment: 200
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Aberration controlled contact lens; Behavioral: Vision training	Phase 2

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double
• Primary Purpose: Prevention
• Official Title: Accommodation Training and Aberration Control in Myopia Development
• Study Start Date: Apr 1, 2005

Outcome Measures

Primary Outcome Measures

1. Change in refractive error in myopia in 6 monthly intervals for 2 years []

2. Change in axial length in 6 monthly intervals for 2 years []

3. Age effects on refractive changes over 2 years []

Secondary Outcome Measures

1. Change in accommodative response in 6 monthly intervals for 2 years []

2. Change in accommodative facility in 6 monthly intervals for 2 years []

3. Change in peripheral refraction in 6 monthly intervals for 2 years []

4. Change in AC/A ratio in 6 monthly intervals for 2 years []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00317551
• Other Study ID Numbers: VisionCRC-ARU
• First Posted: Apr 25, 2006
• Last Update Posted: Oct 17, 2006
• Last Verified: Dec 1, 2005

• Keywords provided by , ,: Aberration control; Accommodative facility; Accommodative response; Peripheral refraction; Accommodative convergence to accommodation ratio
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Oct 17, 2006