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

Conditions
Binocular Vision Disorder
Registration Number
NCT05633212
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes of phoria at different time pointsThe examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

Phoria was measured by phoropter.

Changes of fusion vergence at different time pointsThe examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

Fusion vergence was measured by phoropter.

Changes of accommodative response at different time pointsThe examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

Accommodative response was measured using monocular estimated method.

Changes of relative accommodation at different time pointsThe examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

Relative accommodation was measured by phoropter.

Changes of vergence facility at different time pointsThe examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

Vergence facility was measured by +2.00D/-2.00D flipper.

Changes of accommodative facility at different time pointsThe examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

Accommodative facility was measured by 3△BI/12△BO flipper.

Changes of AC/A at different time pointsThe examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

Gradient AC/A was measured by phoropter.

Changes of near point of convergence at different time pointsThe examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

Near point of convergence was measured using push-up method.

Changes of accommodation amplitude at different time pointsThe examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.

Accommodative amplitude was measured using push-up method.

Secondary Outcome Measures
NameTimeMethod
Changes of brain activation at different time pointsThe examination was performed before operation and 1 month, 6 monthes after ICL implantation.

Functional magnetic resonance imaging activation of the brain

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

🇨🇳

Guangzhou, Guangdong, China

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