CataractsNCT02396719
A Real-World Registry to Investigate the Performance of LenSx® Laser in Chinese Patients
An observational study of Cataracts, run by Alcon Research at 1 site in China.
Trial summary
The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- LenSx® Laser
- Type of treatment
- Medical device
- How many people
- 1,541 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to May 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese patients who undergo cataract surgery using LenSx® Laser and phacoemulsification in at least one eye will be eligible to participate.
Who may be able to join
- Chinese;
- Will undergo LenSx® Laser-assisted cataract surgery and phacoemulsification in at least one eye;
- Must sign written informed consent;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Contraindications listed in LenSx® Laser System Operator's Manual;
- Pregnant, nursing, or planning a pregnancy;
- Concurrent enrollment in another investigational drug and/or device study or participation in such a study within 30 days prior to surgery day;
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-Arm, Multicenter, Registry Study to Investigate the Performance of Femtosecond Laser-Assisted Cataract Surgery in Chinese Cataract Patients
The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.
Read the detailed description
All subjects will undergo FLACS using the LenSx® Laser system. The recommended postoperative visits will follow the current standard of care in China.
- Conditions
- Cataracts
- Being tested
- LenSx® Laser
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenSx® LaserDevice
Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| LenSx | Phacoemulsification cataract surgery in at least 1 eye using LenSx® Laser technology Receives: Device: LenSx® Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of a round anterior capsulotomy
Measured: Surgery (Day 0)
Secondary outcomes (5)
Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure
Measured: Surgery (Day 0)
Completion rate of intraocular lens (IOL) implantation
Measured: Surgery (Day 0)
Completion rate of corneal incisions
Measured: Surgery (Day 0)
Best-corrected distance visual acuity (BCDVA)
Measured: Up to Day 30
Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit
Measured: Up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Time perspective
- Prospective
- Enrolment
- 1,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zuojun Gao, Medical Affairs Director, Study director, Alcon China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396719
- Sponsor's protocol ID
- CTO130-P001
- Status last verified
- Jun 2016
- First submitted
- 19 Mar 2015
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Multicenter, Registry Study to Investigate the Performance of Femtosecond Laser-Assisted Cataract Surgery in Chinese Cataract Patients
- ClinicalTrials.gov ID
- NCT02396719
- Acronym / sponsor ID
- CTO130-P001
- Conditions
- Cataracts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,541 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Mar 2015 (estimated)
- 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.
The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.
Detailed description
All subjects will undergo FLACS using the LenSx® Laser system. The recommended postoperative visits will follow the current standard of care in China.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LenSx | – | Device: LenSx® LaserPhacoemulsification cataract surgery in at least 1 eye using LenSx® Laser technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients who undergo cataract surgery using LenSx® Laser and phacoemulsification in at least one eye will be eligible to participate.
Key inclusion criteria (4 listed)
- Chinese;
- Will undergo LenSx® Laser-assisted cataract surgery and phacoemulsification in at least one eye;
- Must sign written informed consent;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Contraindications listed in LenSx® Laser System Operator's Manual;
- Pregnant, nursing, or planning a pregnancy;
- Concurrent enrollment in another investigational drug and/or device study or participation in such a study within 30 days prior to surgery day;
- Other protocol-specified exclusion criteria may apply.
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 |
|---|---|---|
| LenSx® LaserUsed for cornea incision, capsulotomy and lens fragmentation during cataract surgery | Device | LenSx |
Primary outcome
Completion rate of a round anterior capsulotomy
Time frame: Surgery (Day 0)
5 secondary outcomes
Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure
Time frame: Surgery (Day 0)
Completion rate of intraocular lens (IOL) implantation
Time frame: Surgery (Day 0)
Completion rate of corneal incisions
Time frame: Surgery (Day 0)
Best-corrected distance visual acuity (BCDVA)
Time frame: Up to Day 30
Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit
Time frame: Up to Day 30
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 6 Jun 2016.
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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.
Zuojun Gao, Medical Affairs Director study director
Alcon China
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 Cataracts, run by Alcon Research 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 4 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 6 Jun 2016. 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?
Completion rate of a round anterior capsulotomy (time frame: Surgery (Day 0)). 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 6 Jun 2016.