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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05522972
Other study ID # 2022-344
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 13, 2022
Est. completion date August 31, 2028

Study information

Verified date November 2023
Source Nova Southeastern University
Contact Roger W Li, OD, PhD
Phone 954-262-1436
Email wli@nova.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This study uses psychophysical measures to study neural plasticity in both adults and children with amblyopia.


Description:

Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. Our previous findings (see Publications) show that the adult amblyopic brain is still plastic and malleable, suggesting that active approach is potential useful in treating amblyopia.The goal of this project is to assess the limits and mechanisms of neural plasticity in both normal and amblyopic spatial vision. This study uses psychophysical measures to study neural plasticity in both adults and children with amblyopia. Research participants will be asked to practice a visual discrimination task (perceptual learning) or to play video games with the amblyopic eye for a period of time. A range of visual functions will be monitored during the course of treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date August 31, 2028
Est. primary completion date August 31, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - adults and children with normal vision or amblyopia - amblyopia: interocular VA difference of 0.1 logMAR or more Exclusion Criteria: - any ocular pathological conditions, nystagmus

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Video Game Vision Training
A new approach for improving amblyopic vision using video games
Perceptual Learning
A new approach for improving amblyopic vision with perceptual learning
Occlusion Therapy
Conventional treatment for amblyopia

Locations

Country Name City State
United States Nova Southeastern University College of Optometry Fort Lauderdale Florida

Sponsors (1)

Lead Sponsor Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Leung TW, Li RW, Kee CS. Brief Adaptation to Astigmatism Reduces Meridional Anisotropy in Contrast Sensitivity. Invest Ophthalmol Vis Sci. 2023 Sep 1;64(12):4. doi: 10.1167/iovs.64.12.4. — View Citation

Li RW, Klein SA, Levi DM. Prolonged perceptual learning of positional acuity in adult amblyopia: perceptual template retuning dynamics. J Neurosci. 2008 Dec 24;28(52):14223-9. doi: 10.1523/JNEUROSCI.4271-08.2008. — View Citation

Li RW, Levi DM, Klein SA. Perceptual learning improves efficiency by re-tuning the decision 'template' for position discrimination. Nat Neurosci. 2004 Feb;7(2):178-83. doi: 10.1038/nn1183. Epub 2004 Jan 18. — View Citation

Li RW, Levi DM. Characterizing the mechanisms of improvement for position discrimination in adult amblyopia. J Vis. 2004 Jun 1;4(6):476-87. doi: 10.1167/4.6.7. — View Citation

Li RW, Ngo C, Nguyen J, Levi DM. Video-game play induces plasticity in the visual system of adults with amblyopia. PLoS Biol. 2011 Aug;9(8):e1001135. doi: 10.1371/journal.pbio.1001135. Epub 2011 Aug 30. — View Citation

Li RW, Ngo CV, Levi DM. Relieving the attentional blink in the amblyopic brain with video games. Sci Rep. 2015 Feb 26;5:8483. doi: 10.1038/srep08483. — View Citation

Li RW, Provost A, Levi DM. Extended perceptual learning results in substantial recovery of positional acuity and visual acuity in juvenile amblyopia. Invest Ophthalmol Vis Sci. 2007 Nov;48(11):5046-51. doi: 10.1167/iovs.07-0324. — View Citation

Li RW, So K, Wu TH, Craven AP, Tran TT, Gustafson KM, Levi DM. Monocular blur alters the tuning characteristics of stereopsis for spatial frequency and size. R Soc Open Sci. 2016 Sep 21;3(9):160273. doi: 10.1098/rsos.160273. eCollection 2016 Sep. — View Citation

Li RW, Tran KD, Bui JK, Antonucci MM, Ngo CV, Levi DM. Improving Adult Amblyopic Vision with Stereoscopic 3-Dimensional Video Games. Ophthalmology. 2018 Oct;125(10):1660-1662. doi: 10.1016/j.ophtha.2018.04.025. Epub 2018 May 18. No abstract available. — View Citation

Li RW, Tran TT, Craven AP, Leung TW, Chat SW, Levi DM. Sharpening coarse-to-fine stereo vision by perceptual learning: asymmetric transfer across the spatial frequency spectrum. R Soc Open Sci. 2016 Jan 20;3(1):150523. doi: 10.1098/rsos.150523. eCollection 2016 Jan. — View Citation

Li RW, Young KG, Hoenig P, Levi DM. Perceptual learning improves visual performance in juvenile amblyopia. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3161-8. doi: 10.1167/iovs.05-0286. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in visual acuity before and after the intervention "Visual acuity", the gold standard for vision testing, will be measured. Participants will be asked to read letters on a LogMAR letter chart. The smallest letters that can be read correspond to visual acuity (e.g., Snellen acuity of 20/20, letter-stroke width = 1 minute of arc). 9 months
Primary Change in stereoacuity before and after the intervention "Stereoacuity" will be measured psychophysically using a new stereoacuity function test (1.25, 2.5, 5, 10, 15, & 20 cycles per degree) developed in our previous studies (Li et al 2016). A custom-built 4-mirror haploscope will be used to present a stereogram to each eye. Stereoacuity is the smallest stereo disparity that can be seen in binocular vision (in the unit of seconds of arc, arcsec).
The conventional stereoacuity tests (including Randot Stereoacuity Test, Stereofly Test & Preschool Stereo Test) will also be used to measure stereoacuity. Participants will be asked to wear a pair of 3D glasses and to identify the target 3D pictures at various 3D levels. The smallest 3D disparities that can be seen correspond to stereoacuity (e.g. normal range of stereoacuity: 50 seconds of arc or better).
9 months
Secondary Change in contrast sensitivity before and after the intervention "Contrast sensitivity", the ability to detect low contrast / brightness, will be measured psychophysically for a range of spatial frequencies (1.25, 2.5, 5, 10, & 20 cycles per degree). Visual stimuli at different contrast levels will be displayed on a monitor screen. The smallest detectable stimulus contrast level will be measured in the unit of cd/m2. 9 months
Secondary Change in positional (or Vernier) acuity before and after the intervention "Positional acuity", the ability to detect a subtle positional offset between visual stimuli, will be measured psychophysically. Visual stimuli with different amount of positional offsets will be displayed on a monitor screen. The smallest detectable stimulus offset will be measured as position acuity, in the unit of seconds of arc. 9 months
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