MyopiaACHIEVENCT00522288
Effects of Contact Lens Wear on Children's Self-Perceptions
A study testing Soft contact lenses and Spectacle in people with Myopia, run by Ohio State University at 5 sites in United States.
Trial summary
The purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Soft contact lenses and Spectacle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2003to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
New England College of Optometry
Boston, Massachusetts, 02215
Ohio State University College of Optometry
Columbus, Ohio, 43210-1240
Pacific University College of Optometry
Forest Grove, Oregon, 97116
University of Houston College of Optometry
Houston, Texas, 77204
Southern College of Optometry
Memphis, Tennessee, 38014
About this study
Official title: Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study
The purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.
Read the 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.
- Conditions
- Myopia
- Being tested
- Soft contact lenses, Spectacle
- Keywords
- Myopia, Self-Perception, Contact Lenses, Glasses, Randomized, Children, Self-esteem
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft contact lensesDevice
Also called 1 Day Acuvue or Acuvue 2 contact lenses
Daily wear soft contact lenses disposed of daily or biweekly
SpectacleDevice
Also called Children chose their own frames.
Spectacles for the treatment of myopia
| Study group | Role | What they receive |
|---|---|---|
| Contact Lens | Experimental | Soft contact lenses Receives: Device: Soft contact lenses |
| Spectacle | Active comparator | Spectacles Receives: Device: Spectacle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Self-Worth Scale from the Self-Perception Profile for Children
Measured: 3 years
Secondary outcomes (5)
Five other scales from the Self-Perception Profile for Children
Measured: 3 years
Change in cycloplegic autorefraction
Measured: 3 years
Change in axial length, measured by A-scan ultrasound
Measured: 3 years
Change in corneal curvature, measured by Grand Seiko WR-5100K autokeratometer
Measured: 3 years
Change in Overall score from the Pediatric Refractive Error Profile
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startSep 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Investigators
- Jeffrey J Walline, OD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522288
- Sponsor's protocol ID
- 2003H0114
- Acronym
- ACHIEVE
- Status last verified
- Mar 2011
- First submitted
- 28 Aug 2007
- Last updated
- 21 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16432471Walline 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.
PubMed 15097767Walline 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.
PubMed 19214129Walline 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.
PubMed 18566461Rah 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.
PubMed 20562669Jones-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.
PubMed 20557557Lawrenson 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.
PubMed 36809645
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent and Child Health Initiative to Encourage Vision Empowerment (ACHIEVE) Study
- ClinicalTrials.gov ID
- NCT00522288
- Acronym / sponsor ID
- ACHIEVE / 2003H0114
- Conditions
- Myopia
- Keywords
- Myopia, Self-Perception, Contact Lenses, Glasses, Randomized, Children, Self-esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Johnson & Johnson Vision Care, Inc.
- Study start
- Sep 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 29 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact Lens | Experimental | Device: Soft contact lensesSoft contact lenses |
| Spectacle | Active comparator | Device: SpectacleSpectacles |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft contact lensesAlso: 1 Day Acuvue or Acuvue 2 contact lensesDaily wear soft contact lenses disposed of daily or biweekly | Device | Contact Lens |
| SpectacleAlso: Children chose their own frames.Spectacles for the treatment of myopia | Device | Spectacle |
Primary outcome
Global Self-Worth Scale from the Self-Perception Profile for Children
Time frame: 3 years
5 secondary outcomes
Five other scales from the Self-Perception Profile for Children
Time frame: 3 years
Change in cycloplegic autorefraction
Time frame: 3 years
Change in axial length, measured by A-scan ultrasound
Time frame: 3 years
Change in corneal curvature, measured by Grand Seiko WR-5100K autokeratometer
Time frame: 3 years
Change in Overall score from the Pediatric Refractive Error Profile
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2011.
- Background: PubMed 16432471Walline 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.
- Background: PubMed 15097767Walline 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.
- Results publication: PubMed 19214129Walline 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.
- Results publication: PubMed 18566461Walline 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.
- Results publication: PubMed 20562669Rah 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.
- Results publication: PubMed 20557557Jones-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.
- Derived from this study: PubMed 36809645Lawrenson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J Walline, OD, PhD principal investigator
Ohio State University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft contact lenses and Spectacle in people with Myopia, run by Ohio State University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Self-Worth Scale from the Self-Perception Profile for Children (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00522288, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2011.