Clinical trial NCT00522288: Effects of Contact Lens Wear on Children's Self-Perceptions
Official title: Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Myopia
Self-Perception
Contact Lenses
Glasses
Randomized
Children
Self-esteem
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Vision Care, Inc.
First posted: 2007-08-29
Enrollment: 484
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Global Self-Worth Scale from the Self-Perception Profile for Children
timeFrame: 3 years
Secondary outcomes:
measure: Five other scales from the Self-Perception Profile for Children
timeFrame: 3 years
measure: Change in cycloplegic autorefraction
timeFrame: 3 years
measure: Change in axial length, measured by A-scan ultrasound
timeFrame: 3 years
measure: Change in corneal curvature, measured by Grand Seiko WR-5100K autokeratometer
timeFrame: 3 years
measure: Change in Overall score from the Pediatric Refractive Error Profile
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
city: Columbus
country: United States
facility: Ohio State University College of Optometry
state: Ohio
city: Forest Grove
country: United States
facility: Pacific University College of Optometry
state: Oregon
city: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
Study officials:
affiliation: Ohio State University
name: Jeffrey J Walline, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/01.opx.0000195566.94572.eb.
citation: 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.
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/OPX.0b013e3181971985.
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: 10.1167/iovs.08-2067. Epub 2008 Jun 19.
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.
citation: 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.