Binocular Vision Disorder Clinical Trial
Official title:
Binocular Vision Alternations and Functional Magnetic Resonance Imaging Activation After Implantable Collamer Lens Implantation for High Myopia
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Zhongshan Ophthalmic Center, Sun Yat-sen University |
China,
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
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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