UnknownNot Applicable

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

China50 participantsStarted 2022-03-15

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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.

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.

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.

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.

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.

Trial details

NCT IDNCT05633212

SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-30

Contact for this trial

Yehong Zhuo, doctor

13352828998 zhuoyh@mail.sysu.edu.cn

View on ClinicalTrials.gov More Binocular Vision Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

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.

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.

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.

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.

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.