CClinicalTrials.gg
Status unknownNCT05633212Updated Dec 1, 2022

Binocular Vision Alternations and fMRI Activation After ICL Implantation for High Myopia

An observational study in Binocular Vision Disorder, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-01.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 35 Years
Sex
All
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Study summary

Implantable collamer lens (ICL) is one of the most effective operation for high myopia. Due to refractive correction changed, and prism effect of the spectacle removed, in the early stage after ICL implantation, binocular function might be dysfunction, leading to asthenopia, blurred vision, double vision and so on. This study will recruit the high myopia subjects that scheduled for ICL implantation, purpose to investigate the binocular vision alternations and brain activation that impacted by ICL implantation.

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Conditions studied

  • Binocular Vision Disorder

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Keywords

  • binocular vision, accommodation, vergence, fMRI
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In context

Vision Disorders

308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.

This study's planned enrollment of 50 is below the median of 125 across 84 observational studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The high myopia subjects that scheduled for ICL implantation from Zhongshan Ophthalmic Center, Sun Yat-sen University

Inclusion criteria

  • Age 18-35
  • Spherical equivalent over -6.00DS, astigmatism within -2.00DC, anisometropia within -2.00DS
  • BCVA ≥ 0.8
  • Plan to accept implantable collamer lens surgery
  • Near point of convergence within 10cm
  • Positive fusion vergence over 20pd

Exclusion criteria

Exclusion Criteria:

  • Stabismus
  • Previous ocular surgery or trauma
  • History of vision therapy
  • Monovision and nystagmus
  • Mental disease or craniocerebral trauma
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Changes of phoria at different time points

    Phoria was measured by phoropter.

    Time frame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

  2. Changes of AC/A at different time points

    Gradient AC/A was measured by phoropter.

    Time frame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

  3. Changes of fusion vergence at different time points

    Fusion vergence was measured by phoropter.

    Time frame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

  4. Changes of accommodative response at different time points

    Accommodative response was measured using monocular estimated method.

    Time frame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

  5. Changes of relative accommodation at different time points

    Relative accommodation was measured by phoropter.

    Time frame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

  6. Changes of near point of convergence at different time points

    Near point of convergence was measured using push-up method.

    Time frame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

  7. Changes of accommodation amplitude at different time points

    Accommodative amplitude was measured using push-up method.

    Time frame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

  8. Changes of vergence facility at different time points

    Vergence facility was measured by +2.00D/-2.00D flipper.

    Time frame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

  9. Changes of accommodative facility at different time points

    Accommodative facility was measured by 3△BI/12△BO flipper.

    Time frame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

Secondary outcomes

  1. Changes of brain activation at different time points

    Functional magnetic resonance imaging activation of the brain

    Time frame: The examination was performed before operation and 1 month, 6 monthes after ICL implantation.

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Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
    Recruiting
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References and documents

Publications

  • Zheng K, Han T, Zhou X. Accommodative changes after SMILE for moderate to high myopia correction. BMC Ophthalmol. 2016 Oct 4;16(1):173. doi: 10.1186/s12886-016-0352-8. PubMed 27716112 ↗
  • Han J, Hong S, Lee S, Kim JK, Lee HK, Han SH. Changes in fusional vergence amplitudes after laser refractive surgery for moderate myopia. J Cataract Refract Surg. 2014 Oct;40(10):1670-5. doi: 10.1016/j.jcrs.2014.01.043. Epub 2014 Aug 20. PubMed 25149555 ↗
  • Tsujimoto K, Mizuno K, Nishida D, Tahara M, Yamada E, Shindo S, Kasuga S, Liu M. Prism adaptation changes resting-state functional connectivity in the dorsal stream of visual attention networks in healthy adults: A fMRI study. Cortex. 2019 Oct;119:594-605. doi: 10.1016/j.cortex.2018.10.018. Epub 2018 Oct 31. PubMed 30471844 ↗
  • Wilf M, Serino A, Clarke S, Crottaz-Herbette S. Prism adaptation enhances decoupling between the default mode network and the attentional networks. Neuroimage. 2019 Oct 15;200:210-220. doi: 10.1016/j.neuroimage.2019.06.050. Epub 2019 Jun 22. PubMed 31233909 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05633212
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party
Sponsor
First posted
Dec 1, 2022
Start date
Mar 15, 2022
Primary completion
Jun 30, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Dec 1, 2022

Study contacts

Yehong Zhuo, doctor
Contact
zhuoyh@mail.sysu.edu.cn
13352828998
Junxiong Lin, Master
Contact
linjunxiong@gzzoc.com
13902338172

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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