NCT00335049

Brief Summary

At this time, we do not know what causes a child to become more nearsighted (myopic). STAMP will help us better understand nearsightedness in children. Children will be randomly chosen to wear regular glasses (single vision lenses) or no-line bifocal glasses (progressive addition lenses) for the first year of the study. All children will wear regular glasses for the second year of the study. STAMP will compare how the eye changes shape in the two groups to help us understand why children become nearsighted. The two theories of myopia progression that are being evaluated are based on different factors. One theory is based on environmental factors such as extended near work while the other theory is based on genetically coded factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

3.6 years

First QC Date

June 7, 2006

Last Update Submit

October 27, 2022

Conditions

Myopia

Keywords

myopia progressionbifocal

Outcome Measures

Primary Outcomes (1)

  • Cycloplegic autorefraction

    Baseline, 6, 12, 18, and 24 months

Secondary Outcomes (10)

  • Phoria

    Baseline, 6, 12, 18, and 24 months

  • Accommodative lag

    Baseline, 6, 12, 18, and 24 months

  • AC/A ratio

    Baseline, 6, 12, 18, and 24 months

  • Corneal shape and thickness

    Baseline, 6, 12, 18, and 24 months

  • Intraocular pressure

    Baseline, 6, 12, 18, and 24 months

  • +5 more secondary outcomes

Study Arms (2)

PAL

EXPERIMENTAL

Progressive Addition Spectacle Lenses (PALs) with a +2.00 D add worn for first year off study. Single Vision Lenses worn for second year of study.

Device: progressive addition spectacle lens (bifocal)

SVL

ACTIVE COMPARATOR

Single Vision Lenses (SVLs) worn both years of the study.

Device: Single Vision Lenses (SVLs)

Interventions

progressive addition spectacle lens (bifocal)DEVICE

Progressive addition lenses (PAL) with a +2.00 D add.

Also known as: PAL
PAL
Single Vision Lenses (SVLs)DEVICE

Single vision spectacle lenses.

Also known as: SVL
SVL

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 11 years of age
  • Best corrected vision of at least 20/30 in each eye
  • Birth weight \> 1250g
  • (The criteria below will be evaluated at a screening visit to find out if the child can participate)
  • Accommodative lag \>= 1.30 D (for a 4D stimulus)
  • At least -0.75 D myopia in each meridian measured with cycloplegic autorefraction but not more than -4.50 D in each meridian in each eye
  • Esophoria at near if more than -2.25 D spherical equivalent (high myopia)
  • Astigmatism \< 2.00 DC in each eye
  • Anisometropia \< 2.00 D

You may not qualify if:

  • Strabismus (eye turn)
  • History of contact lens wear
  • History of previous bifocal wear
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

Related Publications (8)

  • Gwiazda J, Thorn F, Bauer J, Held R. Myopic children show insufficient accommodative response to blur. Invest Ophthalmol Vis Sci. 1993 Mar;34(3):690-4.

    PMID: 8449687BACKGROUND

  • Gwiazda J, Hyman L, Hussein M, Everett D, Norton TT, Kurtz D, Leske MC, Manny R, Marsh-Tootle W, Scheiman M. A randomized clinical trial of progressive addition lenses versus single vision lenses on the progression of myopia in children. Invest Ophthalmol Vis Sci. 2003 Apr;44(4):1492-500. doi: 10.1167/iovs.02-0816.

    PMID: 12657584BACKGROUND

  • Mutti DO, Sholtz RI, Friedman NE, Zadnik K. Peripheral refraction and ocular shape in children. Invest Ophthalmol Vis Sci. 2000 Apr;41(5):1022-30.

    PMID: 10752937BACKGROUND

  • Mutti DO, Mitchell GL, Hayes JR, Jones LA, Moeschberger ML, Cotter SA, Kleinstein RN, Manny RE, Twelker JD, Zadnik K; CLEERE Study Group. Accommodative lag before and after the onset of myopia. Invest Ophthalmol Vis Sci. 2006 Mar;47(3):837-46. doi: 10.1167/iovs.05-0888.

    PMID: 16505015BACKGROUND

  • 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.

    PMID: 36809645DERIVED

  • Berntsen DA, Barr CD, Mutti DO, Zadnik K. Peripheral defocus and myopia progression in myopic children randomly assigned to wear single vision and progressive addition lenses. Invest Ophthalmol Vis Sci. 2013 Aug 27;54(8):5761-70. doi: 10.1167/iovs.13-11904.

    PMID: 23838771DERIVED

  • Berntsen DA, Sinnott LT, Mutti DO, Zadnik K. A randomized trial using progressive addition lenses to evaluate theories of myopia progression in children with a high lag of accommodation. Invest Ophthalmol Vis Sci. 2012 Feb 13;53(2):640-9. doi: 10.1167/iovs.11-7769. Print 2012 Feb.

    PMID: 22205604DERIVED

  • Berntsen DA, Mutti DO, Zadnik K. The effect of bifocal add on accommodative lag in myopic children with high accommodative lag. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6104-10. doi: 10.1167/iovs.09-4417. Epub 2010 Aug 4.

    PMID: 20688729DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • David A Berntsen, OD, PhD

    University of Houston

    PRINCIPAL INVESTIGATOR

  • Karla Zadnik, OD, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

  • Donald O Mutti, OD, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 8, 2006

Study Start

December 1, 2006

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 28, 2022

Record last verified: 2022-10

Locations

US(1)