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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05633212
Other study ID # 2022KYPJ198
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date June 30, 2023

Study information

Verified date March 2022
Source Zhongshan Ophthalmic Center, Sun Yat-sen University
Contact Yehong Zhuo, doctor
Phone 13352828998
Email zhuoyh@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of phoria at different time points Phoria was measured by phoropter. The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Primary Changes of AC/A at different time points Gradient AC/A was measured by phoropter. The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Primary Changes of fusion vergence at different time points Fusion vergence was measured by phoropter. The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Primary Changes of accommodative response at different time points Accommodative response was measured using monocular estimated method. The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Primary Changes of relative accommodation at different time points Relative accommodation was measured by phoropter. The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Primary Changes of near point of convergence at different time points Near point of convergence was measured using push-up method. The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Primary Changes of accommodation amplitude at different time points Accommodative amplitude was measured using push-up method. The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Primary Changes of vergence facility at different time points Vergence facility was measured by +2.00D/-2.00D flipper. The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Primary Changes of accommodative facility at different time points Accommodative facility was measured by 3?BI/12?BO flipper. The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Secondary Changes of brain activation at different time points Functional magnetic resonance imaging activation of the brain The examination was performed before operation and 1 month, 6 monthes after ICL implantation.
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