Binocular Vision DisorderNCT05633212
Binocular Vision Alternations and fMRI Activation After ICL Implantation for High Myopia
An observational study of Binocular Vision Disorder, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Binocular Vision Disorder
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The high myopia subjects that scheduled for ICL implantation from Zhongshan Ophthalmic Center, Sun Yat-sen University
Who may be able to join
- 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
Who cannot join
- Stabismus
- Previous ocular surgery or trauma
- History of vision therapy
- Monovision and nystagmus
- Mental disease or craniocerebral trauma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Binocular Vision Alternations and Functional Magnetic Resonance Imaging Activation After Implantable Collamer Lens Implantation for High Myopia
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.
- Conditions
- Binocular Vision Disorder
- Keywords
- binocular vision, accommodation, vergence, fMRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of phoria at different time points
Phoria was measured by phoropter.
Measured: 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
Gradient AC/A was measured by phoropter.
Measured: 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
Fusion vergence was measured by phoropter.
Measured: 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
Accommodative response was measured using monocular estimated method.
Measured: 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
Relative accommodation was measured by phoropter.
Measured: 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
Near point of convergence was measured using push-up method.
Measured: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Changes of accommodation amplitude at different time points
Accommodative amplitude was measured using push-up method.
Measured: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Changes of vergence facility at different time points
Vergence facility was measured by +2.00D/-2.00D flipper.
Measured: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Changes of accommodative facility at different time points
Accommodative facility was measured by 3△BI/12△BO flipper.
Measured: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.
Secondary outcomes (1)
Changes of brain activation at different time points
Functional magnetic resonance imaging activation of the brain
Measured: The examination was performed before operation and 1 month, 6 monthes after ICL implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start15 Mar 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Binocular Vision DisorderStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633212
- Sponsor's protocol ID
- 2022KYPJ198
- Status last verified
- Mar 2022
- First submitted
- 3 Nov 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27716112Han 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.
PubMed 25149555Tsujimoto 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.
PubMed 30471844Wilf 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.
PubMed 31233909
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binocular Vision Alternations and Functional Magnetic Resonance Imaging Activation After Implantable Collamer Lens Implantation for High Myopia
- ClinicalTrials.gov ID
- NCT05633212
- Acronym / sponsor ID
- 2022KYPJ198
- Conditions
- Binocular Vision Disorder
- Keywords
- binocular vision, accommodation, vergence, fMRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The high myopia subjects that scheduled for ICL implantation from Zhongshan Ophthalmic Center, Sun Yat-sen University
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Stabismus
- Previous ocular surgery or trauma
- History of vision therapy
- Monovision and nystagmus
- Mental disease or craniocerebral trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of phoria at different time points
Time frame: The 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 points
Time frame: The 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 points
Time frame: The 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 points
Time frame: The 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 points
Time frame: The 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 points
Time frame: The 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 points
Time frame: The 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 points
Time frame: The 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 points
Time frame: The 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.
1 secondary outcome
Changes of brain activation at different time points
Time frame: The examination was performed before operation and 1 month, 6 monthes after ICL implantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Background: PubMed 27716112Zheng 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.
- Background: PubMed 25149555Han 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.
- Background: PubMed 30471844Tsujimoto 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.
- Background: PubMed 31233909Wilf 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.
- Accommodative changes after SMILE for moderate to high myopia correction.Link provided by the sponsor.
- Changes in fusional vergence amplitudes after laser refractive surgery for moderate myopia.Link provided by the sponsor.
- Prism adaptation changes resting-state functional connectivity in the dorsal stream of visual attention networks in healthy adults: A fMRI study.Link provided by the sponsor.
- Prism adaptation enhances decoupling between the default mode network and the attentional networks.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Binocular Vision Disorder, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehong Zhuo, doctor (13352828998, zhuoyh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of phoria at different time points (time frame: The examination was performed before operation and 1 week, 1 month, 3 monthes, 6 monthes after ICL implantation.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05633212, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.