- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06704503
The Changes Under Different Accommodation of Anterior Eye and 3D Crystal Reconstruction.
May 19, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
To Study the Changes Under Different Accommodation of Anterior Eye in People of Different Ages and 3D Crystal Reconstruction.
Accommodation is defined as a dynamic change in the overall refractive power of the eye during near fixation.
Despite extensive investigations, the exact nature of human accommodation remains controversial.
And recent alternative theories question the original concept of accommodation.Different experts have put forward different hypotheses.
The age-related changes that underlie presbyopia are also not fully understood.Because of these unanswered questions, the topic of regulation and presbyopia remains a focus of research.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Accommodation is the process by which the eye changes the shape and diopter of the lens to obtain a clear image of an object at different distances.
Despite extensive research on regulation, the exact nature of human regulation remains controversial.
Age-related changes in presbyopia are also not fully understood.
Some studies have shown that a hardening of the lens and an increase in the thickness and diameter of the lens with age can lead to presbyopia.
Others believe that the main cause is external lens factors, such as age-related changes in the Angle of lens suspension ligament attachment, reduced ciliary body movement, etc. Due to these unanswered questions, the topic of regulation and presbyopia remains the focus of research.
In living humans, modulation studies utilize different imaging modes, and ultrasound biomicroscopy (UBM) and Optical Coherence Tomography(OCT) are particularly important in studying anterior segments and modulation.
However, UBM is a contact inspection and requires highly skilled technicians.
And UBM cannot image the entire anterior segment in a single capture.
Anterior segment OCT (AS-OCT), on the other hand, is non-invasive and provides higher resolution imaging, allowing us to capture the morphology of the anterior segment structures in different populations and the changes of the anterior segment structures in response to regulatory stimuli.
Studies have shown that with age, reduced anterior chamber depth, pupil contraction, increased lens thickness, increased lens arch height, and loss of posterior ciliary muscle contraction may be biomarkers of early presbyopia.
In this study, anterior segment OCT was used to explore whether there were differences in the structural morphology of the anterior segment in people of different ages, and what changes occurred in the structure of the anterior segment after initiation of regulation.
Study Type
Observational
Enrollment (Estimated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wen Xu, Phd
- Phone Number: +86-13858185223
- Email: xuwen2003@zju.edu.cn
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Recruiting
- Second Affiliated Hospital, Zhejiang University School of Medicine
-
Contact:
- wen xu
- Phone Number: 13858185223
- Email: xuwen2003@zju.edu.cn
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Hangzhou, Zhejiang, China, 310009
- Not yet recruiting
- Second Affiliated Hospital, Zhejiang University School of Medicine
-
Contact:
- Wen Xu, Phd
- Phone Number: +86-13858185223
- Email: xuwen2003@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Age 20-80 years old; Astigmatism ≤-1.50D;
Best corrected visual acuity ≥4.9;Excluding other systemic underlying diseases; Have a history of eye surgery; Patients with intraocular lens or aphakia; Patients with strabismus and amblyopia; Pregnant or lactating women; People with mental disorders or neurological diseases who cannot cooperate with the examination;
Description
Inclusion Criteria:
· Patients with astigmatism ≤-1.50D and best corrected visual acuity ≥4.9
Exclusion Criteria:
- Patients with other systemic diseases
- Patients with a history of eye surgery
- Patients with intraocular lens or aphakia
- Patients with strabismus and amblyopia
- Pregnant or lactating women
- People with mental disorders or neurological diseases who cannot cooperate with the examination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Group A was 20-40 years old
They were divided into three groups according to age: A, B, and C.Group A was 20-40 years old.
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Group B was 40-60 years old
They were divided into three groups according to age: A, B, and C. Group B was 40-60 years old.
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Group C was 60-80 years old
They were divided into three groups according to age: A, B, and C. Group C was 60-80 years old.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Central corneal thickness changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
Central corneal thickness CCT(μm)
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Baseline, after accommodation(30 minutes after using pilocarpine)
|
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peripheral corneal thickness changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
peripheral corneal thickness(μm)
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Baseline, after accommodation(30 minutes after using pilocarpine)
|
|
anterior chamber depth changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
anterior chamber depth ACD(mm)
|
Baseline, after accommodation(30 minutes after using pilocarpine)
|
|
anterior chamber Angle Angle changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
anterior chamber Angle Angle ACA(°)
|
Baseline, after accommodation(30 minutes after using pilocarpine)
|
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anterior opening distance changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
anterior opening distance AOD(mm)
|
Baseline, after accommodation(30 minutes after using pilocarpine)
|
|
pupil size changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
pupil size PD(mm)
|
Baseline, after accommodation(30 minutes after using pilocarpine)
|
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lens thickness changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
lens thickness LT(mm)
|
Baseline, after accommodation(30 minutes after using pilocarpine)
|
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anterior and posterior surface curvature radius changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
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anterior and posterior surface curvature radius(mm)
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Baseline, after accommodation(30 minutes after using pilocarpine)
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|
lens arch height changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
lens arch height LV(mm)
|
Baseline, after accommodation(30 minutes after using pilocarpine)
|
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lens sagittal height changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
lens sagittal height(mm)
|
Baseline, after accommodation(30 minutes after using pilocarpine)
|
|
anterior chamber volume changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
anterior chamber volume(mm³)
|
Baseline, after accommodation(30 minutes after using pilocarpine)
|
|
posterior chamber volume changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
posterior chamber volume(mm³)
|
Baseline, after accommodation(30 minutes after using pilocarpine)
|
|
crystal equatorial diameter changes during accommodation
Time Frame: Baseline, after accommodation(30 minutes after using pilocarpine)
|
crystal equatorial diameter(mm)
|
Baseline, after accommodation(30 minutes after using pilocarpine)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wen Xu, Phd, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
November 17, 2024
First Submitted That Met QC Criteria
November 24, 2024
First Posted (Actual)
November 26, 2024
Study Record Updates
Last Update Posted (Actual)
May 23, 2025
Last Update Submitted That Met QC Criteria
May 19, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2024-0939
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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