Effects of Contact Lens Wear on Children's Self-Perceptions

NCT ID: NCT00522288

Last Updated: 2011-03-21

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

NA

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-10-31

Brief Summary

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

Detailed Description

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Eight to eleven year old children will be randomly assigned to wear spectacles or soft contact lenses. The children's self-perceptions will be measured at baseline and every six months. We will compare the change in self-perception between spectacle and soft contact lens wearers over three years. We will also examine the effect of how much children initially like or dislike to wear glasses on the change in self-perception over three years.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Contact Lens

Soft contact lenses

Group Type EXPERIMENTAL

Soft contact lenses

Intervention Type DEVICE

Daily wear soft contact lenses disposed of daily or biweekly

Spectacle

Spectacles

Group Type ACTIVE_COMPARATOR

Spectacle

Intervention Type DEVICE

Spectacles for the treatment of myopia

Interventions

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Soft contact lenses

Daily wear soft contact lenses disposed of daily or biweekly

Intervention Type DEVICE

Spectacle

Spectacles for the treatment of myopia

Intervention Type DEVICE

Other Intervention Names

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1 Day Acuvue or Acuvue 2 contact lenses Children chose their own frames.

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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College of Optometry, The Ohio State University

Principal Investigators

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Jeffrey J Walline, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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New England College of Optometry

Boston, Massachusetts, United States

Site Status

Ohio State University College of Optometry

Columbus, Ohio, United States

Site Status

Pacific University College of Optometry

Forest Grove, Oregon, United States

Site Status

Southern College of Optometry

Memphis, Tennessee, United States

Site Status

University of Houston College of Optometry

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16432471 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15097767 (View on PubMed)

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.

Reference Type RESULT
PMID: 19214129 (View on PubMed)

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.

Reference Type RESULT
PMID: 18566461 (View on PubMed)

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.

Reference Type RESULT
PMID: 20562669 (View on PubMed)

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.

Reference Type RESULT
PMID: 20557557 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36809645 (View on PubMed)

Other Identifiers

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2003H0114

Identifier Type: -

Identifier Source: org_study_id

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