NCT00317551

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2006

Completed
Last Updated

October 17, 2006

Status Verified

December 1, 2005

First QC Date

April 21, 2006

Last Update Submit

October 16, 2006

Conditions

Myopia

Keywords

Aberration controlAccommodative facilityAccommodative responsePeripheral refractionAccommodative convergence to accommodation ratio

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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

Interventions

Aberration controlled contact lensDEVICE
Vision trainingBEHAVIORAL

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History of systemic/ocular pathology
  • History of any ocular surgery
  • More than 10D of myopia
  • Astigmatism more than 1.00 D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anglia Ruskin University

Cambridge, Cambridgeshire, CB1 1PT, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Daniel J O'Leary, PhD

    University of Wales Institute Cardiff

    STUDY DIRECTOR

  • Peter M Allen, PhD

    Anglia Ruskin University

    STUDY CHAIR

  • Hema Radhakrishnan, PhD

    University of Manchester

    PRINCIPAL INVESTIGATOR

  • Richard I Calver, PhD

    Anglia Ruskin University

    PRINCIPAL INVESTIGATOR

  • Ebi P Osuobeni, PhD

    Anglia Ruskin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2006

First Posted

April 25, 2006

Study Start

April 1, 2005

Last Updated

October 17, 2006

Record last verified: 2005-12

Locations

GB(1)