Subluxation of LensNCT04685122
Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability
An observational study of Subluxation of Lens, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To compare the accuracy of four lens diameter measurement methods and to study the influencing factors of intraocular lens deviation after operation Read more about this study
- Who is it for?
- Ages 20 to 88 years
- Conditions the study is for
- Subluxation of Lens
- What is being tested?
- Phacoemulsification and intraocular lens implantation for cataract
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 Jul 2021
- 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 20 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People whose subluxation of the lens is less than 180 degrees
Who may be able to join
- Subluxation of the lens is less than 180 degrees; (2) Part of the edge of the lens can be seen in the pupil area after the pupil is dilated
Who cannot join
- Total dislocation of the lens to the vitreous cavity (2) Patients with small eyeballs and small eyelid fissures (3) Patients younger than 18 years old (4) Congenital cataracts in both eyes (5) Corneal dystrophy or endothelial cell insufficiency (6) Chronic uvea Inflammation (7) Progressive fundus disease (8) Fragile capsular bag (9) Retinitis pigmentosa or pseudocapsular exfoliation syndrome
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
To compare the accuracy of four lens diameter measurement methods and to study the influencing factors of intraocular lens deviation after operation
- Conditions
- Subluxation of Lens
- Being tested
- Phacoemulsification and intraocular lens implantation for cataract
- Medical subject headings
- Lens Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification and intraocular lens implantation for cataractProcedure or surgery
Phacoemulsification and intraocular lens implantation for cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens diameter
Measured by related instruments before surgery and calculated by the circumference of the tension ring in the surgical video screenshot
Measured: through study completion, an average of 1 year
The eccentric distance of the intraocular lens
The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens.
Measured: 1 week postoperation
The eccentric distance of the intraocular lens
The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens.
Measured: 1 month postoperation
The eccentric distance of the intraocular lens
The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens.
Measured: 3 month postoperation
The tilt angle of the intraocular lens
The angle between the plane of the lens and the plane of the pupil is the inclination of the lens
Measured: 1 week postoperation
The tilt angle of the intraocular lens
The angle between the plane of the lens and the plane of the pupil is the inclination of the lens
Measured: 1 month postoperation
The tilt angle of the intraocular lens
The angle between the plane of the lens and the plane of the pupil is the inclination of the lens
Measured: 3 month postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Nov 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subluxation of LensStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685122
- Sponsor's protocol ID
- xuwen2020-971
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability
- ClinicalTrials.gov ID
- NCT04685122
- Acronym / sponsor ID
- xuwen2020-971
- Conditions
- Subluxation of Lens
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 28 Dec 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.
To compare the accuracy of four lens diameter measurement methods and to study the influencing factors of intraocular lens deviation after operation
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People whose subluxation of the lens is less than 180 degrees
Key inclusion criteria (1 listed)
- Subluxation of the lens is less than 180 degrees; (2) Part of the edge of the lens can be seen in the pupil area after the pupil is dilated
Key exclusion criteria (1 listed)
- Total dislocation of the lens to the vitreous cavity (2) Patients with small eyeballs and small eyelid fissures (3) Patients younger than 18 years old (4) Congenital cataracts in both eyes (5) Corneal dystrophy or endothelial cell insufficiency (6) Chronic uvea Inflammation (7) Progressive fundus disease (8) Fragile capsular bag (9) Retinitis pigmentosa or pseudocapsular exfoliation syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phacoemulsification and intraocular lens implantation for cataractPhacoemulsification and intraocular lens implantation for cataract | Procedure or surgery | – |
Primary outcome
Lens diameter
Time frame: through study completion, an average of 1 year
Measured by related instruments before surgery and calculated by the circumference of the tension ring in the surgical video screenshot
The eccentric distance of the intraocular lens
Time frame: 1 week postoperation
The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens.
The eccentric distance of the intraocular lens
Time frame: 1 month postoperation
The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens.
The eccentric distance of the intraocular lens
Time frame: 3 month postoperation
The distance between the center of the lens plane and the center of the pupil plane is the eccentric distance of the lens.
The tilt angle of the intraocular lens
Time frame: 1 week postoperation
The angle between the plane of the lens and the plane of the pupil is the inclination of the lens
The tilt angle of the intraocular lens
Time frame: 1 month postoperation
The angle between the plane of the lens and the plane of the pupil is the inclination of the lens
The tilt angle of the intraocular lens
Time frame: 3 month postoperation
The angle between the plane of the lens and the plane of the pupil is the inclination of the lens
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- 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.
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 Subluxation of Lens, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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: status not confirmed, as of the sponsor's last update on 28 Dec 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?
Results are not available in the source record.
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?
Lens diameter (time frame: through study completion, an average of 1 year). The study lists 7 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 28 Dec 2020.