Age-related CataractNCT04443101
Effective Lens Position After Cataract Surgery
An observational study of Age-related Cataract, run by Wenzhou Medical University at 2 sites in China.
Trial summary
Cataract patients were implanted with different types of intraocular lenses for grouping. SSOCT scanning was used to measure ELP and optometry. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Age-related Cataract
- What is being tested?
- different types of intracular lens
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2019to 30 Mar 2023
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Diagnosed as cataract in our hospital; * Implanted intraocular lens: SN6CWS, Aspira-aA, MI60; * Cataract phacoemulsification and intraocular lens implantation.
Who may be able to join
- a.Diagnosed as cataract;
- b.Implanted intraocular lens: SN6CWS, Aspira-aA, MI60;
- c.Cataract phacoemulsification and intraocular lens implantation.
Who cannot join
- a.Combined with corneal opacity, glaucoma, uveitis, retinal detachment and other eye diseases;
- b.A history of intraocular surgery or trauma other than cataract surgery;
- c.Intraoperative complications such as tearing of the capsule and IOL failure to implant;
- d.Endophthalmitis, corneal endothelial decompensation and other postoperative complications;
- e.Those with incomplete data collected during the follow-up period of postoperative patients.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Ophthalmology and Optometry Hospital
Wenzhou, Zhejiang, 325027
yun-e zhao, +86 13819707056
- Recruiting
Wenzhou Medical University
Wenzhou, Zhejiang, 325027
XIXIA DING, PHD, 86-057788068859
About this study
Official title: Comparison of Changes in Effective Lens Position of Different Types of Intraocular Lens
Cataract patients were implanted with different types of intraocular lenses for grouping. SSOCT scanning was used to measure ELP and optometry.
Read the detailed description
Cataract patients were implanted with different types of intraocular lenses for grouping. Perform SSOCT scan that was used to measure effective lens position and optometry at different postoperative follow-up time .
- Conditions
- Age-related Cataract
- Being tested
- different types of intracular lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different types of intracular lensOther
different types of intracular lens
| Study group | Role | What they receive |
|---|---|---|
| Group（SN6CWS） | Group（SN6CWS）：Implant SN6CWS intraocular lens Receives: Other: different types of intracular lens | |
| Group（MI60） | Group（MI60）：Implant MI60 intraocular lens Receives: Other: different types of intracular lens | |
| Group（Aspira-aA） | Group（Aspira-aA）：Implant Aspira-aA intraocular lens Receives: Other: different types of intracular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
effective lens position
Changes of effective lens position at different time points after cataract surgery
Measured: up to 3 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jan 2019
- Primary completion30 May 2022
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yin ying zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443101
- Sponsor's protocol ID
- SSOCT-ELP
- Status last verified
- Mar 2023
- First submitted
- 17 Jun 2020
- Last updated
- 7 Mar 2023
- 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 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Changes in Effective Lens Position of Different Types of Intraocular Lens
- ClinicalTrials.gov ID
- NCT04443101
- Acronym / sponsor ID
- SSOCT-ELP
- Conditions
- Age-related Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 23 Jun 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.
Cataract patients were implanted with different types of intraocular lenses for grouping. SSOCT scanning was used to measure ELP and optometry.
Detailed description
Cataract patients were implanted with different types of intraocular lenses for grouping. Perform SSOCT scan that was used to measure effective lens position and optometry at different postoperative follow-up time .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group（SN6CWS） | – | Other: different types of intracular lensGroup（SN6CWS）：Implant SN6CWS intraocular lens |
| Group（MI60） | – | Other: different types of intracular lensGroup（MI60）：Implant MI60 intraocular lens |
| Group（Aspira-aA） | – | Other: different types of intracular lensGroup（Aspira-aA）：Implant Aspira-aA intraocular lens |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Diagnosed as cataract in our hospital; * Implanted intraocular lens: SN6CWS, Aspira-aA, MI60; * Cataract phacoemulsification and intraocular lens implantation.
Key inclusion criteria (3 listed)
- a.Diagnosed as cataract;
- b.Implanted intraocular lens: SN6CWS, Aspira-aA, MI60;
- c.Cataract phacoemulsification and intraocular lens implantation.
Key exclusion criteria (5 listed)
- a.Combined with corneal opacity, glaucoma, uveitis, retinal detachment and other eye diseases;
- b.A history of intraocular surgery or trauma other than cataract surgery;
- c.Intraoperative complications such as tearing of the capsule and IOL failure to implant;
- d.Endophthalmitis, corneal endothelial decompensation and other postoperative complications;
- e.Those with incomplete data collected during the follow-up period of postoperative patients.
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 |
|---|---|---|
| different types of intracular lensdifferent types of intracular lens | Other | Group（Aspira-aA）, Group（MI60）, Group（SN6CWS） |
Primary outcome
effective lens position
Time frame: up to 3 months after cataract surgery
Changes of effective lens position at different time points after cataract surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- 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.
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 Age-related Cataract, run by Wenzhou Medical University 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 3 inclusion and 5 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 7 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xixia ding, Phd (+8613780148109, dingxixiaxc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effective lens position (time frame: up to 3 months after cataract surgery). 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 7 Mar 2023.