AccommodationNCT06704503
The Changes Under Different Accommodation of Anterior Eye and 3D Crystal Reconstruction.
An observational study of Accommodation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Accommodation
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 27 Nov 2024to 31 Dec 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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;
Who may be able to join
- Patients with astigmatism ≤-1.50D and best corrected visual acuity ≥4.9
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Wen Xu, PHD, +86-13858185223, xuwen2003@zju.edu.cn
- Recruiting
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
wen xu, 13858185223, xuwen2003@zju.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Accommodation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central corneal thickness changes during accommodation
Central corneal thickness CCT(μm)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
peripheral corneal thickness changes during accommodation
peripheral corneal thickness(μm)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
anterior chamber depth changes during accommodation
anterior chamber depth ACD(mm)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
anterior chamber Angle Angle changes during accommodation
anterior chamber Angle Angle ACA(°)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
anterior opening distance changes during accommodation
anterior opening distance AOD(mm)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
pupil size changes during accommodation
pupil size PD(mm)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
lens thickness changes during accommodation
lens thickness LT(mm)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
anterior and posterior surface curvature radius changes during accommodation
anterior and posterior surface curvature radius(mm)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
lens arch height changes during accommodation
lens arch height LV(mm)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
lens sagittal height changes during accommodation
lens sagittal height(mm)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
anterior chamber volume changes during accommodation
anterior chamber volume(mm³)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
posterior chamber volume changes during accommodation
posterior chamber volume(mm³)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
crystal equatorial diameter changes during accommodation
crystal equatorial diameter(mm)
Measured: Baseline, after accommodation(30 minutes after using pilocarpine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start27 Nov 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AccommodationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Xu, Phd, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704503
- Sponsor's protocol ID
- 2024-0939
- Status last verified
- May 2025
- First submitted
- 17 Nov 2024
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Changes Under Different Accommodation of Anterior Eye in People of Different Ages and 3D Crystal Reconstruction.
- ClinicalTrials.gov ID
- NCT06704503
- Acronym / sponsor ID
- 2024-0939
- Conditions
- Accommodation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Nov 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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;
Key inclusion criteria (1 listed)
- Patients with astigmatism ≤-1.50D and best corrected visual acuity ≥4.9
Key exclusion criteria (6 listed)
- 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
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
Central corneal thickness changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
Central corneal thickness CCT(μm)
peripheral corneal thickness changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
peripheral corneal thickness(μm)
anterior chamber depth changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
anterior chamber depth ACD(mm)
anterior chamber Angle Angle changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
anterior chamber Angle Angle ACA(°)
anterior opening distance changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
anterior opening distance AOD(mm)
pupil size changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
pupil size PD(mm)
lens thickness changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
lens thickness LT(mm)
anterior and posterior surface curvature radius changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
anterior and posterior surface curvature radius(mm)
lens arch height changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
lens arch height LV(mm)
lens sagittal height changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
lens sagittal height(mm)
anterior chamber volume changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
anterior chamber volume(mm³)
posterior chamber volume changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
posterior chamber volume(mm³)
crystal equatorial diameter changes during accommodation
Time frame: Baseline, after accommodation(30 minutes after using pilocarpine)
crystal equatorial diameter(mm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Wen Xu, Phd principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accommodation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Xu, Phd (+86-13858185223, xuwen2003@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central corneal thickness changes during accommodation (time frame: Baseline, after accommodation(30 minutes after using pilocarpine)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2025.