Clinical trial NCT05633212: Binocular Vision Alternations and fMRI Activation After ICL Implantation for High Myopia
Official title: Binocular Vision Alternations and Functional Magnetic Resonance Imaging Activation After Implantable Collamer Lens Implantation for High Myopia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Binocular Vision Disorder
Keywords: binocular vision, accommodation, vergence, fMRI
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The high myopia subjects that scheduled for ICL implantation from Zhongshan Ophthalmic Center, Sun Yat-sen University

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of phoria at different time points
timeFrame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
measure: Changes of AC/A at different time points
timeFrame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
measure: Changes of fusion vergence at different time points
timeFrame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
measure: Changes of accommodative response at different time points
timeFrame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
measure: Changes of relative accommodation at different time points
timeFrame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
measure: Changes of near point of convergence at different time points
timeFrame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
measure: Changes of accommodation amplitude at different time points
timeFrame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
measure: Changes of vergence facility at different time points
timeFrame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
measure: Changes of accommodative facility at different time points
timeFrame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Secondary outcomes:
measure: Changes of brain activation at different time points
timeFrame: The examination was performed before operation and 1 month, 6 monthes after ICL implantation.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
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.
citation: 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.
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.
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.