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

NCT ID: NCT00317551

Last Updated: 2006-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Myopia

Keywords

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Aberration control Accommodative facility Accommodative response Peripheral refraction Accommodative convergence to accommodation ratio

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Aberration controlled contact lens

Intervention Type DEVICE

Vision training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vision CRC

UNKNOWN

Sponsor Role collaborator

Anglia Ruskin University

OTHER

Sponsor Role lead

Principal Investigators

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Daniel J O'Leary, PhD

Role: STUDY_DIRECTOR

University of Wales Institute Cardiff

Peter M Allen, PhD

Role: STUDY_CHAIR

Anglia Ruskin University

Hema Radhakrishnan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Richard I Calver, PhD

Role: PRINCIPAL_INVESTIGATOR

Anglia Ruskin University

Ebi P Osuobeni, PhD

Role: PRINCIPAL_INVESTIGATOR

Anglia Ruskin University

Locations

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Anglia Ruskin University

Cambridge, Cambridgeshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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VisionCRC-ARU

Identifier Type: -

Identifier Source: org_study_id