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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05633212
Enrollment
50
Registered
2022-12-01
Start date
2022-03-15
Completion date
2023-06-30
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binocular Vision Disorder

Keywords

binocular vision, accommodation, vergence, fMRI

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.

Interventions

None listed

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 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 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 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 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.
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.

Secondary

MeasureTime frameDescription
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

Countries

China

Contacts

Primary ContactYehong Zhuo, doctor
zhuoyh@mail.sysu.edu.cn13352828998
Backup ContactJunxiong Lin, Master
linjunxiong@gzzoc.com13902338172

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026