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

Myopia Clinical Trial

— ACHIEVE  

Official title:

Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522288
• Other study ID #: 2003H0114
• Status: Completed
• Phase: N/A
• First received: August 28, 2007
• Last updated: March 17, 2011
• Start date: September 2003
• Est. completion date: October 2007

Study information

• Verified date: March 2011
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Soft contact lenses
Daily wear soft contact lenses disposed of daily or biweekly
• Spectacle
Spectacles for the treatment of myopia

Locations

Country	Name	City	State
United States	New England College of Optometry	Boston	Massachusetts
United States	Ohio State University College of Optometry	Columbus	Ohio
United States	Pacific University College of Optometry	Forest Grove	Oregon
United States	University of Houston College of Optometry	Houston	Texas
United States	Southern College of Optometry	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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: 10.116 — View Citation

Walline JJ, Long S, Zadnik K. Daily disposable contact lens wear in myopic children. Optom Vis Sci. 2004 Apr;81(4):255-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Self-Worth Scale from the Self-Perception Profile for Children		3 years	No
Secondary	Five other scales from the Self-Perception Profile for Children		3 years	No
Secondary	Change in cycloplegic autorefraction		3 years	No
Secondary	Change in axial length, measured by A-scan ultrasound		3 years	No
Secondary	Change in corneal curvature, measured by Grand Seiko WR-5100K autokeratometer		3 years	No
Secondary	Change in Overall score from the Pediatric Refractive Error Profile		3 years	No