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

NCT05633212 | Unknown DMC

• 1 other identifier: 2022KYPJ198
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Binocular Vision Disorder

Keywords

binocular vision, accommodation, vergence, fMRI

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Changes of brain activation at different time points

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 27716112 BACKGROUND

• 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.

  PMID: 25149555 BACKGROUND

• 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.

  PMID: 30471844 BACKGROUND

• 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.

  PMID: 31233909 BACKGROUND

Related 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.

Central Study Contacts

Yehong Zhuo, doctor

CONTACT

13352828998; zhuoyh@mail.sysu.edu.cn

Junxiong Lin, Master

CONTACT

13902338172; linjunxiong@gzzoc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: December 1, 2022
• Study Start: March 15, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)