NCT00522288

Brief Summary

The purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
484

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 21, 2011

Status Verified

March 1, 2011

Enrollment Period

4.1 years

First QC Date

August 28, 2007

Last Update Submit

March 17, 2011

Conditions

Keywords

MyopiaSelf-PerceptionContact LensesGlassesRandomizedChildrenSelf-esteem

Outcome Measures

Primary Outcomes (1)

  • Global Self-Worth Scale from the Self-Perception Profile for Children

    3 years

Secondary Outcomes (5)

  • Five other scales from the Self-Perception Profile for Children

    3 years

  • Change in cycloplegic autorefraction

    3 years

  • Change in axial length, measured by A-scan ultrasound

    3 years

  • Change in corneal curvature, measured by Grand Seiko WR-5100K autokeratometer

    3 years

  • Change in Overall score from the Pediatric Refractive Error Profile

    3 years

Study Arms (2)

Contact Lens

EXPERIMENTAL

Soft contact lenses

Device: Soft contact lenses

Spectacle

ACTIVE COMPARATOR

Spectacles

Device: Spectacle

Interventions

Daily wear soft contact lenses disposed of daily or biweekly

Also known as: 1 Day Acuvue or Acuvue 2 contact lenses
Contact Lens
SpectacleDEVICE

Spectacles for the treatment of myopia

Also known as: Children chose their own frames.
Spectacle

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 6.00 D spherical component myopia, based on cycloplegic autorefraction
  • DC or less astigmatism, based on cycloplegic autorefraction
  • /20 or better best-corrected visual acuity in each eye
  • Global stereoacuity of 250 seconds of arc or better based on Randot stereoacuity

You may not qualify if:

  • Contact lens wear within the past month
  • Ocular health problems that could affect vision, eye development, or contact lens wear
  • Systemic health problems that could affect understanding of surveys or contact lens wear
  • Participation in other eye or vision studies that prescribed a treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

New England College of Optometry

Boston, Massachusetts, 02215, United States

Location

Ohio State University College of Optometry

Columbus, Ohio, 43210-1240, United States

Location

Pacific University College of Optometry

Forest Grove, Oregon, 97116, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38014, United States

Location

University of Houston College of Optometry

Houston, Texas, 77204, United States

Location

Related Publications (7)

  • Walline JJ, Jones LA, Chitkara M, Coffey B, Jackson JM, Manny RE, Rah MJ, Prinstein MJ, Zadnik K. The Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) study design and baseline data. Optom Vis Sci. 2006 Jan;83(1):37-45. doi: 10.1097/01.opx.0000195566.94572.eb.

    PMID: 16432471BACKGROUND
  • Walline JJ, Long S, Zadnik K. Daily disposable contact lens wear in myopic children. Optom Vis Sci. 2004 Apr;81(4):255-9. doi: 10.1097/00006324-200404000-00011.

    PMID: 15097767BACKGROUND
  • Walline JJ, Jones LA, Sinnott L, Chitkara M, Coffey B, Jackson JM, Manny RE, Rah MJ, Prinstein MJ; ACHIEVE Study Group. Randomized trial of the effect of contact lens wear on self-perception in children. Optom Vis Sci. 2009 Mar;86(3):222-32. doi: 10.1097/OPX.0b013e3181971985.

  • Walline JJ, Jones LA, Sinnott L, Manny RE, Gaume A, Rah MJ, Chitkara M, Lyons S; ACHIEVE Study Group. A randomized trial of the effect of soft contact lenses on myopia progression in children. Invest Ophthalmol Vis Sci. 2008 Nov;49(11):4702-6. doi: 10.1167/iovs.08-2067. Epub 2008 Jun 19.

  • Rah MJ, Walline JJ, Jones-Jordan LA, Sinnott LT, Jackson JM, Manny RE, Coffey B, Lyons S; ACHIEVE Study Group. Vision specific quality of life of pediatric contact lens wearers. Optom Vis Sci. 2010 Aug;87(8):560-6. doi: 10.1097/OPX.0b013e3181e6a1c8.

  • Jones-Jordan LA, Chitkara M, Coffey B, Jackson JM, Manny RE, Rah MJ, Walline JJ. A comparison of spectacle and contact lens wearing times in the ACHIEVE study. Clin Exp Optom. 2010 May;93(3):157-63. doi: 10.1111/j.1444-0938.2010.00480.x.

  • Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses, HydrophilicEyeglasses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Contact LensesLensesOptical DevicesEquipment and Supplies

Study Officials

  • Jeffrey J Walline, OD, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 29, 2007

Study Start

September 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

March 21, 2011

Record last verified: 2011-03

Locations