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

NCT ID: NCT05633212

Last Updated: 2022-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-15

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Binocular Vision Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* Stabismus
* Previous ocular surgery or trauma
* History of vision therapy
* Monovision and nystagmus
* Mental disease or craniocerebral trauma
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yehong Zhuo, doctor

Role: CONTACT

13352828998

Junxiong Lin, Master

Role: CONTACT

13902338172

References

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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.

Reference Type BACKGROUND
PMID: 27716112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25149555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30471844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31233909 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/27716112/

Accommodative changes after SMILE for moderate to high myopia correction.

https://pubmed.ncbi.nlm.nih.gov/25149555/

Changes in fusional vergence amplitudes after laser refractive surgery for moderate myopia.

https://pubmed.ncbi.nlm.nih.gov/30471844/

Prism adaptation changes resting-state functional connectivity in the dorsal stream of visual attention networks in healthy adults: A fMRI study.

https://pubmed.ncbi.nlm.nih.gov/31233909/

Prism adaptation enhances decoupling between the default mode network and the attentional networks.

Other Identifiers

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2022KYPJ198

Identifier Type: -

Identifier Source: org_study_id

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