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

Binocular Vision Disorder Clinical Trial

Official title:

Binocular Vision Alternations and Functional Magnetic Resonance Imaging Activation After Implantable Collamer Lens Implantation for High Myopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633212
• Other study ID #: 2022KYPJ198
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Binocular Vision Disorder
• Vision Disorders

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.

External Links

•   Accommodative changes after SMILE for moderate to high myopia correction.
•   Changes in fusional vergence amplitudes after laser refractive surgery for moderate myopia.
•   Prism adaptation changes resting-state functional connectivity in the dorsal stream of visual attention networks in healthy adults: A fMRI study.
•   Prism adaptation enhances decoupling between the default mode network and the attentional networks.