Subluxation of LensNCT04062084
Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery
A study testing Multifunctional Cataract-assisted Retractor in people with Subluxation of Lens and Surgical Instruments，Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To compare the safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subluxation of Lens, Surgical Instruments，Cataract
- What is being tested?
- Multifunctional Cataract-assisted Retractor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 30 Nov 2021
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of lens subluxation.
- Patients need to undergo lens subluxation surgery
Who cannot join
- Active intraocular inflammation
- The intraocular pressure (IOP) was higher than 25 mmHg
- The endothelial cell count (ECC) was less than 1,200 cells/mm2
- Combined with other eye diseases
- Combined with other serious systemic diseases
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 safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.
- Conditions
- Subluxation of Lens, Surgical Instruments，Cataract
- Being tested
- Multifunctional Cataract-assisted Retractor
- Medical subject headings
- Lens Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifunctional Cataract-assisted RetractorDevice
Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens
| Study group | Role | What they receive |
|---|---|---|
| Multifunctional Cataract-assisted Retractor | Experimental | Patients undergoing cataract with lens subluxation surgery with Multifunctional cataract-assisted retractor Receives: Device: Multifunctional Cataract-assisted Retractor |
| Capsule Retractor | Experimental | Patients undergoing cataract with lens subluxation surgery with traditional capsule retractor Receives: Device: Multifunctional Cataract-assisted Retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success rate
Surgical success rate of operation with different retractor
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Successful implantation rate of intraocular lens
implantation rate of intraocular lens with different retractor
Measured: through study completion, an average of 1 year
Visual function
Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart
Measured: 1day postoperation，1 week，1 month， 3month postoperation
intraocular pressure
intraocular pressure
Measured: 1 day, 1 week, 1 month, and 3 month postoperation
endothelial cell count
endothelial cell count
Measured: 1 week, 1 month, and 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 posted20 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062084
- Sponsor's protocol ID
- xuwen2017-034
- Status last verified
- Dec 2020
- First submitted
- 31 Jul 2019
- Last updated
- 5 Apr 2021
- 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 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery
- ClinicalTrials.gov ID
- NCT04062084
- Acronym / sponsor ID
- xuwen2017-034
- Conditions
- Subluxation of Lens, Surgical Instruments，Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 20 Aug 2019 (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 safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifunctional Cataract-assisted Retractor | Experimental | Device: Multifunctional Cataract-assisted RetractorPatients undergoing cataract with lens subluxation surgery with Multifunctional cataract-assisted retractor |
| Capsule Retractor | Experimental | Device: Multifunctional Cataract-assisted RetractorPatients undergoing cataract with lens subluxation surgery with traditional capsule retractor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of lens subluxation.
- Patients need to undergo lens subluxation surgery
Key exclusion criteria (5 listed)
- Active intraocular inflammation
- The intraocular pressure (IOP) was higher than 25 mmHg
- The endothelial cell count (ECC) was less than 1,200 cells/mm2
- Combined with other eye diseases
- Combined with other serious systemic diseases
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 |
|---|---|---|
| Multifunctional Cataract-assisted RetractorMultifunctional Cataract-assisted retractor operation for cataract with subluxation of lens | Device | Capsule Retractor, Multifunctional Cataract-assisted Retractor |
Primary outcome
Surgical success rate
Time frame: through study completion, an average of 1 year
Surgical success rate of operation with different retractor
4 secondary outcomes
Successful implantation rate of intraocular lens
Time frame: through study completion, an average of 1 year
Visual function
Time frame: 1day postoperation，1 week，1 month， 3month postoperation
intraocular pressure
Time frame: 1 day, 1 week, 1 month, and 3 month postoperation
endothelial cell count
Time frame: 1 week, 1 month, and 3 month postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- 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?
A study testing Multifunctional Cataract-assisted Retractor in people with Subluxation of Lens and Surgical Instruments，Cataract, 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 2 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 5 Apr 2021. 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?
Surgical success rate (time frame: through study completion, an average of 1 year). 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 5 Apr 2021.