Intraocular Lens ImplantationCVPOCTRNCT04880018
Clinical Validation Plan of Capsular Tension Ring
A study testing Capsular Tension Ring in people with Intraocular Lens Implantation, run by Eyebright Medical Technology (Beijing) Co., Ltd..
Trial summary
Through follow-up for 1 year or more, the safety and effectiveness of the Capsular Tension Ring produced by Eyebright Medical Technology (Beijing) Co., Ltd. were verified, which is used for intraocular lens implantation in aphakic eyes after lens extraction to maintain capsular integrity, prevent posterior capsular… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Lens Implantation
- What is being tested?
- Capsular Tension Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2015to 24 Oct 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old, no gender limit;
- For cataract patients who are expected to undergo phacoemulsification + Capsular Tension Ring and intraocular lens implantation, the hardness of the surgical eye nucleus is 1 to 3;
- Be able to understand the purpose of the trial, voluntarily participate in and sign informed consent form by the patient himself or his legal guardian.
- Over 18 years old, no gender limit;
- For cataract patients who are expected to undergo phacoemulsification + Capsular Tension Ring and intraocular lens implantation, the hardness of the surgical eye nucleus is 1 to 3;
- Be able to understand the purpose of the trial, voluntarily participate in and sign informed consent form by the patient himself or his legal guardian.
Who cannot join
- The surgical eye has other ocular diseases, those with Capsular Tension Ring implantation or intraocular operation contraindications, such as binocular congenital cataracts, microphthalmia, children under the age of 12 months, corneal dystrophy or endothelial cell insufficiency, chronic uveitis, active ocular diseases (Diabetic retinopathy active stage, uncontrollable glaucoma), fragile capsular bag, zonular rupture exceeding 120 degrees, etc.
- Accompanied by severe or unstable heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, mental and nerve dysfunction and other diseases;
- The surgical eye has had retinal detachment or retinopathy;
- Patients with congenital cataracts undergoing operation;
- Those whose electrocardiogram examination or laboratory examination results suggest surgical contraindications;
- Those who are unsupervised or cannot follow the doctor's advice;
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- Those with a history of intraocular operation in the last 3 months;
- It is estimated that the best corrected distance visual acuity after operation is less than 20/40;
- Those who need combined eye operation;
- Participated in clinical trials of other drugs or medical devices within 30 days before screening;
- Patients who are using or need to use ocular or systemic drugs during the research period that may affect their visual acuity;
- Pregnant or breastfeeding women;
- Those who have been judged by the researcher to ignore the function of the contralateral eye;
- The researcher judges that the patient is not suitable for other situations.
About this study
Through follow-up for 1 year or more, the safety and effectiveness of the Capsular Tension Ring produced by Eyebright Medical Technology (Beijing) Co., Ltd. were verified, which is used for intraocular lens implantation in aphakic eyes after lens extraction to maintain capsular integrity, prevent posterior capsular wrinkle and resist capsular shrinkage.
The clinical validation plan will be implemented after being approved by the Ethics Committee; the trial data of all cases before the 6-month visit period will be counted, and the statistical report, summary report and sub-center summary will be issued. The summary report and sub-center summary will be submitted to the CFDA for product registration.
Read the detailed description
According to the principle of "Quality management standard for clinical trials of medical devices" issued by CFDA, a multi-center, randomized, open, positive product, parallel controlled trial design was adopted to evaluate the safety and effectiveness of the Capsular Tension Ring produced by Eyebright Medical Technology (Beijing) Co., Ltd.
Considering the progress of clinical verification and the reliability of the conclusion, the multi-center trial design was adopted in this clinical verification. Multi-center clinical trials can collect more cases in a short time, and cover a wide population of cases, which avoids the limitations of a single research, and the conclusions can have a wider significance and greater credibility. In order to demonstrate the effectiveness and safety of the product, and to verify whether the product has the same efficacy and safety as the marketed product, a positive product and a parallel controlled trial design were selected for the validation; The "Capsular Tension Ring" produced by Carl Zeiss, with the same material, structure, design, implantation mode and location, and indications, was selected as the positive parallel control product, and the clinical trial was conducted simultaneously with the validation product. In view of the fact that this clinical trial is a comparative research of positive products and parallel controls, in order to ensure the comparability of cases in each group, avoid bias caused by various factors in the design, execution, and analysis of the clinical trial. This clinical verification adopts a randomization method and uses a central random system to achieve dynamic randomization to ensure that cases are evenly allocated to the test group or the control group. Due to the variety of product specifications in this clinical verification, the use of the verification product and the reference substance is slightly different. This verification cannot be double-blind, so an open clinical trial design is adopted.
Based on the above considerations and adhering to the scientific principle, in order to verify the safety and effectiveness of the Capsular Tension Ring produced by Eyebright, a multi-center, randomized, open, positive product, parallel controlled trial method was adopted in this clinical verification.
At the same time, 120 cases of cataract patients were selected according to the statistical requirements. After screening and examination, those who met the inclusion criteria were selected for validation. Surgical treatment and implantation of validation or control products were performed. Clinical follow-up evaluation was planned at 1-2 days, 1 week, 1 month, 3 months, 6 months and 1 year after operation. The percentage of patients whose best corrected visual acuity reached 20/40 at 6 months after operation was taken as the main efficacy indicator; At the same time, observe the visual acuity, optometry results, intraocular pressure, lens eccentricity, capsule shrinkage, etc. after 1~2 days, 1 week, 1 month, 3 months, 6 months and 1 year or more after operation; The main safety indicators are the incidence of complications, adverse events and serious adverse events during the observation period, and adverse events and serious adverse events related to the validated device.
- Conditions
- Intraocular Lens Implantation
- Being tested
- Capsular Tension Ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsular Tension RingDevice
Experimental group uses Capsular Tension Ring from Eyebright Medical Technology (Beijing) Co., Ltd;control group uses Capsular Tension Ring from Carl Zeiss Medical Technology Co., Ltd
| Study group | Role | What they receive |
|---|---|---|
| Capsular Tension Ring from Eyebright Medical Technology (Beijing) Co., Ltd | Experimental | Specification model: CTR1109、CTR1210、CTR1311、CTR1412、CTR1513 Manufacturer: Eyebright Medical Technology (Beijing) Co., Ltd. Receives: Device: Capsular Tension Ring |
| Capsular Tension Ring from Carl Zeiss Medical Technology Co., Ltd | Active comparator | Specification model: TENSIOBAG 10、TENSIOBAG 11、TENSIOBAG 12、TENSIOBAG 13、TENSIOBAG14 Manufacturer: Carl Zeiss Medical Technology Co., Ltd. Receives: Device: Capsular Tension Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected distance visual acuity
The percentage of eyes whose best corrected distance visual acuity reached 20/40 at 6 months after operation
Measured: At 6 months after operation
Secondary outcomes (4)
Best corrected distance visual acuity, uncorrected distance visual acuity
Visual acuity in 1~2 days, 1 week, 1 month, 3 months, 6 months, 1 year
Measured: In 1~2 days, 1 week, 1 month, 3 months, 6 months, 1 year
Diopter
Dioptric power of 1 to 2 days, 1 week, 1 month, 3 months, 6 months, 1 year
Measured: In 1~ 2 days, 1 week, 1 month, 3 months, 6 months, 1 year
The intraocular lens eccentricity
Eccentricity of intraocular lens of 1 to 2 days, 1 week, 1 month, 3 months, 6 months, 1 year
Measured: In 1~ 2 days, 1 week, 1 month, 3 months, 6 months, 1 year
The capsular shrinkage
Capsule contraction of 1 to 2 days, 1 week, 1 month, 3 months, 6 months, 1 year
Measured: In 1~ 2 days, 1 week, 1 month, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start21 May 2015
- Primary completion20 Jun 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Lens ImplantationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyebright Medical Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Ye, PhD, Study directorYong Zhong, PhD, Study directorQi Han, PhD, Study director, Tianjin Medical University General HospitalJun Fang, PhD, Study director, Daqing Oil Field HospitalAyong Yv, PhD, Study director, Opto-optic Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880018
- Sponsor's protocol ID
- EB/JS-QD-123
- Other IDs
- 2015QXNL002
- Acronym
- CVPOCTR
- Status last verified
- May 2021
- First submitted
- 29 Apr 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Plan of Capsular Tension Ring
- ClinicalTrials.gov ID
- NCT04880018
- Acronym / sponsor ID
- CVPOCTR / EB/JS-QD-123
- Conditions
- Intraocular Lens Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Eyebright Medical Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 May 2015 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 10 May 2021 (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.
Through follow-up for 1 year or more, the safety and effectiveness of the Capsular Tension Ring produced by Eyebright Medical Technology (Beijing) Co., Ltd. were verified, which is used for intraocular lens implantation in aphakic eyes after lens extraction to maintain capsular integrity, prevent posterior capsular wrinkle and resist capsular shrinkage.
The clinical validation plan will be implemented after being approved by the Ethics Committee; the trial data of all cases before the 6-month visit period will be counted, and the statistical report, summary report and sub-center summary will be issued. The summary report and sub-center summary will be submitted to the CFDA for product registration.
Detailed description
According to the principle of "Quality management standard for clinical trials of medical devices" issued by CFDA, a multi-center, randomized, open, positive product, parallel controlled trial design was adopted to evaluate the safety and effectiveness of the Capsular Tension Ring produced by Eyebright Medical Technology (Beijing) Co., Ltd.
Considering the progress of clinical verification and the reliability of the conclusion, the multi-center trial design was adopted in this clinical verification. Multi-center clinical trials can collect more cases in a short time, and cover a wide population of cases, which avoids the limitations of a single research, and the conclusions can have a wider significance and greater credibility. In order to demonstrate the effectiveness and safety of the product, and to verify whether the product has the same efficacy and safety as the marketed product, a positive product and a parallel controlled trial design were selected for the validation; The "Capsular Tension Ring" produced by Carl Zeiss, with the same material, structure, design, implantation mode and location, and indications, was selected as the positive parallel control product, and the clinical trial was conducted simultaneously with the validation product. In view of the fact that this clinical trial is a comparative research of positive products and parallel controls, in order to ensure the comparability of cases in each group, avoid bias caused by various factors in the design, execution, and analysis of the clinical trial. This clinical verification adopts a randomization method and uses a central random system to achieve dynamic randomization to ensure that cases are evenly allocated to the test group or the control group. Due to the variety of product specifications in this clinical verification, the use of the verification product and the reference substance is slightly different. This verification cannot be double-blind, so an open clinical trial design is adopted.
Based on the above considerations and adhering to the scientific principle, in order to verify the safety and effectiveness of the Capsular Tension Ring produced by Eyebright, a multi-center, randomized, open, positive product, parallel controlled trial method was adopted in this clinical verification.
At the same time, 120 cases of cataract patients were selected according to the statistical requirements. After screening and examination, those who met the inclusion criteria were selected for validation. Surgical treatment and implantation of validation or control products were performed. Clinical follow-up evaluation was planned at 1-2 days, 1 week, 1 month, 3 months, 6 months and 1 year after operation. The percentage of patients whose best corrected visual acuity reached 20/40 at 6 months after operation was taken as the main efficacy indicator; At the same time, observe the visual acuity, optometry results, intraocular pressure, lens eccentricity, capsule shrinkage, etc. after 1~2 days, 1 week, 1 month, 3 months, 6 months and 1 year or more after operation; The main safety indicators are the incidence of complications, adverse events and serious adverse events during the observation period, and adverse events and serious adverse events related to the validated device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsular Tension Ring from Eyebright Medical Technology (Beijing) Co., Ltd | Experimental | Device: Capsular Tension RingSpecification model: CTR1109、CTR1210、CTR1311、CTR1412、CTR1513 Manufacturer: Eyebright Medical Technology (Beijing) Co., Ltd. |
| Capsular Tension Ring from Carl Zeiss Medical Technology Co., Ltd | Active comparator | Device: Capsular Tension RingSpecification model: TENSIOBAG 10、TENSIOBAG 11、TENSIOBAG 12、TENSIOBAG 13、TENSIOBAG14 Manufacturer: Carl Zeiss Medical Technology Co., Ltd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years old, no gender limit;
- For cataract patients who are expected to undergo phacoemulsification + Capsular Tension Ring and intraocular lens implantation, the hardness of the surgical eye nucleus is 1 to 3;
- Be able to understand the purpose of the trial, voluntarily participate in and sign informed consent form by the patient himself or his legal guardian.
- Over 18 years old, no gender limit;
- For cataract patients who are expected to undergo phacoemulsification + Capsular Tension Ring and intraocular lens implantation, the hardness of the surgical eye nucleus is 1 to 3;
Key exclusion criteria (14 listed)
- The surgical eye has other ocular diseases, those with Capsular Tension Ring implantation or intraocular operation contraindications, such as binocular congenital cataracts, microphthalmia, children under the age of 12 months, corneal dystrophy or endothelial cell insufficiency, chronic uveitis, active ocular diseases (Diabetic retinopathy active stage, uncontrollable glaucoma), fragile capsular bag, zonular rupture exceeding 120 degrees, etc.
- Accompanied by severe or unstable heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, mental and nerve dysfunction and other diseases;
- The surgical eye has had retinal detachment or retinopathy;
- Patients with congenital cataracts undergoing operation;
- Those whose electrocardiogram examination or laboratory examination results suggest surgical contraindications;
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 |
|---|---|---|
| Capsular Tension RingExperimental group uses Capsular Tension Ring from Eyebright Medical Technology (Beijing) Co., Ltd;control group uses Capsular Tension Ring from Carl Zeiss Medical Technology Co., Ltd | Device | Capsular Tension Ring from Carl Zeiss Medical Technology Co., Ltd, Capsular Tension Ring from Eyebright Medical Technology (Beijing) Co., Ltd |
Primary outcome
Best corrected distance visual acuity
Time frame: At 6 months after operation
The percentage of eyes whose best corrected distance visual acuity reached 20/40 at 6 months after operation
4 secondary outcomes
Best corrected distance visual acuity, uncorrected distance visual acuity
Time frame: In 1~2 days, 1 week, 1 month, 3 months, 6 months, 1 year
Diopter
Time frame: In 1~ 2 days, 1 week, 1 month, 3 months, 6 months, 1 year
The intraocular lens eccentricity
Time frame: In 1~ 2 days, 1 week, 1 month, 3 months, 6 months, 1 year
The capsular shrinkage
Time frame: In 1~ 2 days, 1 week, 1 month, 3 months, 6 months, 1 year
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 10 May 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.
Jian Ye, PhD study director
Yong Zhong, PhD study director
Qi Han, PhD study director
Tianjin Medical University General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Capsular Tension Ring in people with Intraocular Lens Implantation, run by Eyebright Medical Technology (Beijing) Co., Ltd..
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 6 inclusion and 14 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Best corrected distance visual acuity (time frame: At 6 months after operation). 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 10 May 2021.