CataractNCT04576884
Age-Related Changes and Cycloplegia-Induced Differences in the Human Crystalline Lens
An observational study of Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
The ocular biometric parameters of the human crystalline lens including anterior chamber depth (ACD), lens thickness (LT), radii of curvature of anterior and posterior lens (ALR and PLR), lens equatorial diameter (LED), and lens vault (LV), automatically quantified by the CASIA2 (SS-OCT; Tomey, Nagoya, Japan). Read more about this study
- Who is it for?
- Ages 6 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Jan 2020
- 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 6 to 86 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia) at Eye hospital of Wenzhou Medical University
Who may be able to join
- Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia) Must be able to cooperate examination
Who cannot join
- ocular diseases other than cataracts history of eye surgeries or injuries shallow anterior chamber with a risk of angle closure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Age-Related Changes and Cycloplegia-Induced Differences of the Human Crystalline Lens, Schlemm' s Canal and Trabecular Meshwork：an in Vivo Swept-Source Optical Coherence Tomography Study
The ocular biometric parameters of the human crystalline lens including anterior chamber depth (ACD), lens thickness (LT), radii of curvature of anterior and posterior lens (ALR and PLR), lens equatorial diameter (LED), and lens vault (LV), automatically quantified by the CASIA2 (SS-OCT; Tomey, Nagoya, Japan). Images of iridocorneal angle were obtained using CASIA2 and the Schlemm' s canal (SC) and trabecular meshwork (TM) were quantified manually. Both cycloplegia and non-cycloplegia images were obtained.
Read the detailed description
Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia), were consecutively included from April to May 2019. All participants underwent visual acuity, dry and wet refraction, anterior and posterior segment examination, intraocular pressure (IOP), and axial length (AL) using IOL-Master 700 (Carl Zeiss Meditec AG). Investigators recruited children under 18 years old at a refraction outpatient clinic, who were prescribed cyclopentolate hydrochloride eyedrops (S.A. Alcon-Couvreur N.V., Belguim) for cycloplegic refraction. For adults, they were prescribed compound tropicamide eyedrops (Mydrin-P, Santen Pharmaceutical Co., Ltd, Osaka, Japan), consisting of 0.5% tropicamide mixed with 0.5% phenylephrine hydrochloride, for pupillary dilation in order to perform fundus examination at an outpatient clinic. Exclusion criteria were as follow:ocular diseases other than cataracts; history of eye surgeries or injuries; shallow anterior chamber with a risk of angle closure. The data from right eye was selected for analysis.
- Conditions
- Cataract
- Keywords
- radius of curvature, lens thickness, equatorial diameter, lens vault, cycloplegia, swept-source optical coherence tomography, schlemm' s canal, trabecular meshwork
- Medical subject headings
- Cataract
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 1 | participants of less than 18 years old | |
| Group 2 | participants aged from 18 years to 40 year | |
| Group 3 | participants aged from 41 years to 60 years | |
| Group 4 | participants over 60 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired Comparison Before and After Cycloplegia
The cycloplegia-induced differences of parameters was defined as: the post-cycloplegic value minus the pre-cycloplegic value.
Measured: 2020.2.3
Evaluated the effect of age on the TM/SC morphologies
The age-related variations of TM/SC parameters from four age groups were compared.
Measured: 2020.2.3
Secondary outcomes (1)
Evaluated the effect of age on the ocular biometric data
The age-related variations of ocular biometric data such as axial length (AL), lens thickness (LT), and anterior chamber depth (ACD) from four age groups were compared.
Measured: 2020.2.3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Apr 2019
- Primary completion31 May 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
- Investigators
- Yune Zhao, Study director, Ophthalmology and Optometry Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576884
- Sponsor's protocol ID
- SSOCT-ocular parameters change
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Z, Meng Z, Qu W, Li X, Chang P, Wang D, Zhao Y. The Relationship Between Age and the Morphology of the Crystalline Lens, Ciliary Muscle, Trabecular Meshwork, and Schlemm's Canal: An in vivo Swept-Source Optical Coherence Tomography Study. Front Physiol. 2021 Nov 19;12:763736. doi: 10.3389/fphys.2021.763736. eCollection 2021.
PubMed 34867468
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Changes and Cycloplegia-Induced Differences of the Human Crystalline Lens, Schlemm' s Canal and Trabecular Meshwork：an in Vivo Swept-Source Optical Coherence Tomography Study
- ClinicalTrials.gov ID
- NCT04576884
- Acronym / sponsor ID
- SSOCT-ocular parameters change
- Conditions
- Cataract
- Keywords
- radius of curvature, lens thickness, equatorial diameter, lens vault, cycloplegia, swept-source optical coherence tomography, schlemm' s canal, trabecular meshwork
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 6 Oct 2020 (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.
The ocular biometric parameters of the human crystalline lens including anterior chamber depth (ACD), lens thickness (LT), radii of curvature of anterior and posterior lens (ALR and PLR), lens equatorial diameter (LED), and lens vault (LV), automatically quantified by the CASIA2 (SS-OCT; Tomey, Nagoya, Japan). Images of iridocorneal angle were obtained using CASIA2 and the Schlemm' s canal (SC) and trabecular meshwork (TM) were quantified manually. Both cycloplegia and non-cycloplegia images were obtained.
Detailed description
Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia), were consecutively included from April to May 2019. All participants underwent visual acuity, dry and wet refraction, anterior and posterior segment examination, intraocular pressure (IOP), and axial length (AL) using IOL-Master 700 (Carl Zeiss Meditec AG). Investigators recruited children under 18 years old at a refraction outpatient clinic, who were prescribed cyclopentolate hydrochloride eyedrops (S.A. Alcon-Couvreur N.V., Belguim) for cycloplegic refraction. For adults, they were prescribed compound tropicamide eyedrops (Mydrin-P, Santen Pharmaceutical Co., Ltd, Osaka, Japan), consisting of 0.5% tropicamide mixed with 0.5% phenylephrine hydrochloride, for pupillary dilation in order to perform fundus examination at an outpatient clinic. Exclusion criteria were as follow:ocular diseases other than cataracts; history of eye surgeries or injuries; shallow anterior chamber with a risk of angle closure. The data from right eye was selected for analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –participants of less than 18 years old |
| Group 2 | – | –participants aged from 18 years to 40 year |
| Group 3 | – | –participants aged from 41 years to 60 years |
| Group 4 | – | –participants over 60 years old |
Who may qualify
- Ages
- 6 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia) at Eye hospital of Wenzhou Medical University
Key inclusion criteria (1 listed)
- Healthy individuals aged between 6 and 90 years, without history of ocular disease (except age-related cataract and/or myopia) Must be able to cooperate examination
Key exclusion criteria (1 listed)
- ocular diseases other than cataracts history of eye surgeries or injuries shallow anterior chamber with a risk of angle closure
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
Paired Comparison Before and After Cycloplegia
Time frame: 2020.2.3
The cycloplegia-induced differences of parameters was defined as: the post-cycloplegic value minus the pre-cycloplegic value.
Evaluated the effect of age on the TM/SC morphologies
Time frame: 2020.2.3
The age-related variations of TM/SC parameters from four age groups were compared.
1 secondary outcome
Evaluated the effect of age on the ocular biometric data
Time frame: 2020.2.3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 34867468Li Z, Meng Z, Qu W, Li X, Chang P, Wang D, Zhao Y. The Relationship Between Age and the Morphology of the Crystalline Lens, Ciliary Muscle, Trabecular Meshwork, and Schlemm's Canal: An in vivo Swept-Source Optical Coherence Tomography Study. Front Physiol. 2021 Nov 19;12:763736. doi: 10.3389/fphys.2021.763736. eCollection 2021.
Related trials for Cataract
RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Yune Zhao study director
Ophthalmology and Optometry Hospital
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 Cataract, run by Wenzhou Medical 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired Comparison Before and After Cycloplegia (time frame: 2020.2.3). The study lists 2 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 NCT04576884, which also lists 1 linked publication.
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 6 Oct 2020.