CataractsNCT02605408
Cataract Surgery in Indian Patients With or Without LenSx® Laser
An observational study of Cataracts, run by Alcon Research.
Trial summary
The purpose of this study is to record and analyze the profile and outcome of cataract patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL) implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian tertiary medical centers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- LenSx® laser system and Phacoemulsification
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jun 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with cataracts who are receiving phacoemulsification (with or without LenSx® procedure) consecutively during the registry period
Who may be able to join
- Agree to undergo phacoemulsification cataract surgery in at least 1 eye;
- Understand and sign an informed consent form;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Refuse to sign the informed consent form or have incomplete medical records;
- Contraindications for phacoemulsification treatment per Investigator discretion or listed in LenSx® Operator's Manual;
- Contraindications for anterior capsulotomy, phacofragmentation of the lens using the FLACS;
- Other protocol-specified exclusion criteria may apply.
About this study
Official title: A Phaco ± LenSx® Procedure Patients Registry in Indian Tertiary Medical Centers
The purpose of this study is to record and analyze the profile and outcome of cataract patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL) implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian tertiary medical centers.
Read the detailed description
Legitimate patients will receive Standard of Care (SOC) phacoemulsification treatment for cataract and IOL implantation, with or without using LenSx® technology, with followup for 1 month using SOC postsurgical treatment.
- Conditions
- Cataracts
- Being tested
- LenSx® laser system, Phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenSx® laser systemDevice
Femtosecond laser system used for cornea incision, capsulotomy and lens fragmentation during cataract surgery
PhacoemulsificationProcedure or surgery
Removal of the cataractous lens
| Study group | Role | What they receive |
|---|---|---|
| Cataract surgery | Phacoemulsification and artificial IOL implantation with and without LenSx® laser system Receives: Device: LenSx® laser system; Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of an anterior capsulotomy
Measured: Day 0, operative day
Best Corrected Visual Acuity (BCVA)
Measured: Up to Day 30 postoperative
Uncorrected Visual Acuity (UCVA)
Measured: Up to Day 30 postoperative
Cumulative dissipated energy (CDE)
Cumulative Dissipated Energy (the amount of ultrasound energy entering the eye during the removal of the cataractous lens) will be reported on the Vision System interface and measured in percent-seconds.
Measured: Day 0, operative day
Total phaco + IOL time
Measured: Day 0, operative day
Aspiration fluid (ml)
Measured: Day 0, operative day
Success rate of IOL insertion
Measured: Day 0, operative day
Completion rate of cornea incision
Measured: Day 0, operative day
Laser procedure time from suction on to off
Measured: Day 0, operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startApr 2016
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: Management Decision
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head Medical Affairs, MD, Study director, Alcon India Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605408
- Sponsor's protocol ID
- CTI742-P001
- Status last verified
- Apr 2016
- First submitted
- 6 Nov 2015
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phaco ± LenSx® Procedure Patients Registry in Indian Tertiary Medical Centers
- ClinicalTrials.gov ID
- NCT02605408
- Acronym / sponsor ID
- CTI742-P001
- Conditions
- Cataracts
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Management Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 16 Nov 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 record and analyze the profile and outcome of cataract patients receiving phacoemulsification (phaco) and artificial intraocular lens (IOL) implantation with or without femtosecond laser-assisted cataract surgery (FLACS) in Indian tertiary medical centers.
Detailed description
Legitimate patients will receive Standard of Care (SOC) phacoemulsification treatment for cataract and IOL implantation, with or without using LenSx® technology, with followup for 1 month using SOC postsurgical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract surgery | – | Device: LenSx® laser system, Procedure: PhacoemulsificationPhacoemulsification and artificial IOL implantation with and without LenSx® laser system |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with cataracts who are receiving phacoemulsification (with or without LenSx® procedure) consecutively during the registry period
Key inclusion criteria (3 listed)
- Agree to undergo phacoemulsification cataract surgery in at least 1 eye;
- Understand and sign an informed consent form;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Refuse to sign the informed consent form or have incomplete medical records;
- Contraindications for phacoemulsification treatment per Investigator discretion or listed in LenSx® Operator's Manual;
- Contraindications for anterior capsulotomy, phacofragmentation of the lens using the FLACS;
- 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® laser systemFemtosecond laser system used for cornea incision, capsulotomy and lens fragmentation during cataract surgery | Device | Cataract surgery |
| PhacoemulsificationRemoval of the cataractous lens | Procedure or surgery | Cataract surgery |
Primary outcome
Completion rate of an anterior capsulotomy
Time frame: Day 0, operative day
Best Corrected Visual Acuity (BCVA)
Time frame: Up to Day 30 postoperative
Uncorrected Visual Acuity (UCVA)
Time frame: Up to Day 30 postoperative
Cumulative dissipated energy (CDE)
Time frame: Day 0, operative day
Cumulative Dissipated Energy (the amount of ultrasound energy entering the eye during the removal of the cataractous lens) will be reported on the Vision System interface and measured in percent-seconds.
Total phaco + IOL time
Time frame: Day 0, operative day
Aspiration fluid (ml)
Time frame: Day 0, operative day
Success rate of IOL insertion
Time frame: Day 0, operative day
Completion rate of cornea incision
Time frame: Day 0, operative day
Laser procedure time from suction on to off
Time frame: Day 0, operative day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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.
Head Medical Affairs, MD study director
Alcon India Pvt. Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataracts, run by Alcon Research.
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 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: withdrawn, as of the sponsor's last update on 27 Apr 2016. 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 was withdrawn before enrolling participants, so there are no results.
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 an anterior capsulotomy (time frame: Day 0, operative day). The study lists 9 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 27 Apr 2016.