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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Binocular Vision Disorder

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Yehong Zhuo, doctor; Phone Number: 13352828998; Email: zhuoyh@mail.sysu.edu.cn
• Study Contact Backup: Name: Junxiong Lin, Master; Phone Number: 13902338172; Email: linjunxiong@gzzoc.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: binocular vision, accommodation, vergence, fMRI
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders
• Other Study ID Numbers: 2022KYPJ198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No