NCT03341780

Brief Summary

Amblyopia is characterized by a reduction in visual acuity, contrast sensitivity, and binocular visual functions. The two main causes of amblyopia are anisometropia and strabismus which alter the synaptic connections between neurons along the visual pathway. Current treatment for amblyopia has indicated that the younger the amblyope, the greater the effect of treatment. The purpose of this study is to determine if standard amblyopia treatment improved visual acuity in adult amblyopes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

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

Study Start

First participant enrolled

December 16, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

November 9, 2017

Last Update Submit

November 13, 2017

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (1)

  • visual acuity

    LogMAR acuity will be measured with the eETDRS chart

    24 weeks

Interventions

amblyopia therapyPROCEDURE

Any of the following amblyopia training activities may be employed during patching: board games, card games, coloring in O's, comic books, craft projects, crossword puzzles, dot-to-dot patterns, drawing, hammering nails, jacks, jigsaw puzzles, lego and other blocks, marbles, mazes, peg-board activities, perceptual materials, pickup sticks, reading, sewing, shooting games, stringing beads, throwing or hitting games, tracing, and video or computer games.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from the College community and University Eye Clinic. An announcement will be made to the College community and volunteers accepted.

You may qualify if:

  • Amblyopic patients with acuities between 20/40 (0.30 logMAR) and 20/400 (1.30 logMAR).
  • All subjects will be over the age of 18.

You may not qualify if:

  • Subjects will be recruited from the College community and University Eye Clinic.
  • A significant cataract that affects vision.
  • Glaucoma, diabetes, uncontrolled high blood pressure.
  • Other ocular or systemic diseases that will affect visual acuity.
  • The inability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • von Noorden GK. Amblyopia: a multidisciplinary approach. Proctor lecture. Invest Ophthalmol Vis Sci. 1985 Dec;26(12):1704-16.

    PMID: 3934105BACKGROUND

  • Michaels DD. Visual optics and refraction: a clinical approach. St Louis, MO: C.V. Mosby Co.; 1980.

    BACKGROUND

  • Crawford ML, Blake R, Cool SJ, von Noorden GK. Physiological consequences of unilateral and bilateral eye closure in macaque monkeys: some further observations. Brain Res. 1975 Jan 24;84(1):150-4. doi: 10.1016/0006-8993(75)90809-4. No abstract available.

    PMID: 1111823BACKGROUND

  • Hubel DH, Wiesel TN, LeVay S. Plasticity of ocular dominance columns in monkey striate cortex. Philos Trans R Soc Lond B Biol Sci. 1977 Apr 26;278(961):377-409. doi: 10.1098/rstb.1977.0050. No abstract available.

    PMID: 19791BACKGROUND

  • Stewart CE, Moseley MJ, Stephens DA, Fielder AR. Treatment dose-response in amblyopia therapy: the Monitored Occlusion Treatment of Amblyopia Study (MOTAS). Invest Ophthalmol Vis Sci. 2004 Sep;45(9):3048-54. doi: 10.1167/iovs.04-0250.

    PMID: 15326120BACKGROUND

  • Repka MX, Beck RW, Holmes JM, Birch EE, Chandler DL, Cotter SA, Hertle RW, Kraker RT, Moke PS, Quinn GE, Scheiman MM; Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol. 2003 May;121(5):603-11. doi: 10.1001/archopht.121.5.603.

    PMID: 12742836BACKGROUND

  • Holmes JM, Kraker RT, Beck RW, Birch EE, Cotter SA, Everett DF, Hertle RW, Quinn GE, Repka MX, Scheiman MM, Wallace DK; Pediatric Eye Disease Investigator Group. A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology. 2003 Nov;110(11):2075-87. doi: 10.1016/j.ophtha.2003.08.001.

    PMID: 14597512BACKGROUND

  • Holmes JM, Edwards AR, Beck RW, Arnold RW, Johnson DA, Klimek DL, Kraker RT, Lee KA, Lyon DW, Nosel ER, Repka MX, Sala NA, Silbert DI, Tamkins S; Pediatric Eye Disease Investigator Group. A randomized pilot study of near activities versus non-near activities during patching therapy for amblyopia. J AAPOS. 2005 Apr;9(2):129-36. doi: 10.1016/j.jaapos.2004.12.014.

    PMID: 15838439BACKGROUND

  • Holmes JM, Lazar EL, Melia BM, Astle WF, Dagi LR, Donahue SP, Frazier MG, Hertle RW, Repka MX, Quinn GE, Weise KK; Pediatric Eye Disease Investigator Group. Effect of age on response to amblyopia treatment in children. Arch Ophthalmol. 2011 Nov;129(11):1451-7. doi: 10.1001/archophthalmol.2011.179. Epub 2011 Jul 11.

    PMID: 21746970BACKGROUND

  • Levi DM, Li RW. Perceptual learning as a potential treatment for amblyopia: a mini-review. Vision Res. 2009 Oct;49(21):2535-49. doi: 10.1016/j.visres.2009.02.010. Epub 2009 Feb 27.

    PMID: 19250947BACKGROUND

  • Levi DM, Li RW. Improving the performance of the amblyopic visual system. Philos Trans R Soc Lond B Biol Sci. 2009 Feb 12;364(1515):399-407. doi: 10.1098/rstb.2008.0203.

    PMID: 19008199BACKGROUND

  • Ridder WH 3rd, Rouse MW. Predicting potential acuities in amblyopes: predicting post-therapy acuity in amblyopes. Doc Ophthalmol. 2007 May;114(3):135-45. doi: 10.1007/s10633-007-9048-y. Epub 2007 Feb 20.

    PMID: 17310345BACKGROUND

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Ridder, OD, PhD

    Southern California College of Optometry at Marshall B. Ketchum University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 14, 2017

Study Start

December 16, 2014

Primary Completion

October 24, 2016

Study Completion

October 24, 2016

Last Updated

November 17, 2017

Record last verified: 2017-11