Crystalline CataractNCT04487795
Age-related Changes of Crystalline Lens Tilt and Decentration: A Swept-source Optical Coherence Tomography Study
An observational study of Crystalline Cataract and Lens; Anomaly, run by Yune Zhao at 1 site in China.
Trial summary
230 participants at Eye Hospital of Wenzhou Medical University during June, 2019 and August, 2019 were enrolled in this study. 230 right eyes and 88 left eyes were included for the measurement. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Crystalline Cataract, Lens; Anomaly
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2020to 17 May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy volunteers and patients with age-related cataract at Eye hospital of Wenzhou Medical University
Who may be able to join
- healthy volunteers and patients with age-related cataract
Who cannot join
- aphakia or pseudophakia
- any other ocular diseases with the exception of senile cataract
- any history of ocular surgery
- fixation difficulties caused by any reasons
Trial locations and contacts
1 site in 1 country.
About this study
230 participants at Eye Hospital of Wenzhou Medical University during June, 2019 and August, 2019 were enrolled in this study. 230 right eyes and 88 left eyes were included for the measurement. All the measurements were performed under non-mydriatic conditions in a dim examination room using the CASIA2 swept-source AS-OCT system.
- Conditions
- Crystalline Cataract, Lens; Anomaly
- Keywords
- crystalline lens tilt, crystalline lens decentration, swept-source optical coherence tomography
- Medical subject headings
- Congenital Abnormalities
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 |
|---|---|---|
| under 18 years old | Not described | |
| 18-40 years old | Not described | |
| 41-60 years old | Not described | |
| over 60 years old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
crystalline lens tilt
magnitude and direction of crystalline lens lilt
Measured: 2020.4.30
crystalline lens decentration
magnitude and direction of crystalline lens decentration
Measured: 2020.4.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start15 Apr 2020
- Primary completion30 Apr 2020
- Study completion17 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crystalline 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
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yune Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487795
- Sponsor's protocol ID
- SSOCT-lens tilt
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Changes of Crystalline Lens Tilt and Decentration: A Swept-source Optical Coherence Tomography Study
- ClinicalTrials.gov ID
- NCT04487795
- Acronym / sponsor ID
- SSOCT-lens tilt
- Conditions
- Crystalline Cataract, Lens; Anomaly
- Keywords
- crystalline lens tilt, crystalline lens decentration, swept-source optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Yune ZhaoUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 17 May 2020 (actual)
- First posted
- 27 Jul 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.
230 participants at Eye Hospital of Wenzhou Medical University during June, 2019 and August, 2019 were enrolled in this study. 230 right eyes and 88 left eyes were included for the measurement. All the measurements were performed under non-mydriatic conditions in a dim examination room using the CASIA2 swept-source AS-OCT system.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| under 18 years old | – | – |
| 18-40 years old | – | – |
| 41-60 years old | – | – |
| over 60 years old | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers and patients with age-related cataract at Eye hospital of Wenzhou Medical University
Key inclusion criteria (1 listed)
- healthy volunteers and patients with age-related cataract
Key exclusion criteria (4 listed)
- aphakia or pseudophakia
- any other ocular diseases with the exception of senile cataract
- any history of ocular surgery
- fixation difficulties caused by any reasons
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
crystalline lens tilt
Time frame: 2020.4.30
magnitude and direction of crystalline lens lilt
crystalline lens decentration
Time frame: 2020.4.30
magnitude and direction of crystalline lens decentration
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 27 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Crystalline Cataract and Lens; Anomaly, run by Yune Zhao 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 4 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 27 Jul 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?
crystalline lens tilt (time frame: 2020.4.30). 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?
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 27 Jul 2020.