Intumescent CataractNCT02403206
Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
A study testing Femtosecond laser and Continuous Curvilinear Capsulorhexis (CCC) in people with Intumescent Cataract, run by Alcon, a Novartis Company.
Trial summary
The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Intumescent Cataract
- What is being tested?
- Femtosecond laser and Continuous Curvilinear Capsulorhexis (CCC)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2015to 24 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Willing to undergo cataract surgery.
- Able to lie flat in a supine position.
- Able to understand and willing to sign the Informed Consent Form (ICF).
- Presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Pregnant or lactating mothers.
- Corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength.
- Corneal opacity that would interfere with the laser beam.
- Presence of blood or other material in the anterior chamber.
- Hypotony or presence of corneal implant.
- Poorly dilating pupils.
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- Condition which would cause inadequate clearance between the intended capsulotomy depth and the endothelium.
- Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality.
- Any contraindication to cataract surgery.
- Other protocol-specified exclusion criteria may apply.
About this study
The purpose of the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag.
- Conditions
- Intumescent Cataract
- Being tested
- Femtosecond laser, Continuous Curvilinear Capsulorhexis (CCC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond laserDevice
Also called LenSx® Laser
Laser console and a patient interface used to cut tissue during cataract removal of the crystalline lens
Continuous Curvilinear Capsulorhexis (CCC)Procedure or surgery
Standard-of care manual procedure (using either needles or forceps) for creating capsulorhexis, ie., opening in capsular bag during anterior segment ophthalmic surgery
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery Receives: Device: Femtosecond laser |
| Manual | Active comparator | Continuous curvilinear capsulorhexis performed during cataract surgery Receives: Procedure: Continuous Curvilinear Capsulorhexis (CCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Capsular Tears (Anterior or Posterior) During Surgery
A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.
Measured: Day 0 (operative day)
Secondary outcomes (1)
Operating Time in the Eye to Complete Entire Cataract Procedure
Operating time in the eye was the time interval (in seconds) from the time the corneal incision was opened to the time the wound was closed. Only one eye (study eye) contributed to the analysis.
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 posted31 Mar 2015 (estimated)
- Study start26 Mar 2015
- Primary completion12 Jul 2016
- Study completion24 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intumescent 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon, a Novartis Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Manager, Surgical, Study director, Alcon, A Novartis Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403206
- Sponsor's protocol ID
- CTW860-P001
- Status last verified
- Jun 2017
- First submitted
- 26 Mar 2015
- Last updated
- 2 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
- ClinicalTrials.gov ID
- NCT02403206
- Acronym / sponsor ID
- CTW860-P001
- Conditions
- Intumescent Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Alcon, a Novartis CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- 12 Jul 2016 (actual)
- Study completion
- 24 Aug 2016 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 25 Jul 2017
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 the study is to compare femtosecond laser-assisted capsulotomy to manual capsulorhexis in patients with intumescent cataracts. An intumescent cataract is defined as a cataract with a pressurized capsular bag.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Device: Femtosecond laserFemtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery |
| Manual | Active comparator | Procedure: Continuous Curvilinear Capsulorhexis (CCC)Continuous curvilinear capsulorhexis performed during cataract surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to undergo cataract surgery.
- Able to lie flat in a supine position.
- Able to understand and willing to sign the Informed Consent Form (ICF).
- Presenting with intumescent white cataract, with a liquid pressurized bag and a milky, liquid cortex.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (10 listed)
- Pregnant or lactating mothers.
- Corneal disease that precludes application of the cornea or transmission of laser light at 1030 nanometer (nm) wavelength.
- Corneal opacity that would interfere with the laser beam.
- Presence of blood or other material in the anterior chamber.
- Hypotony or presence of corneal implant.
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 |
|---|---|---|
| Femtosecond laserAlso: LenSx® LaserLaser console and a patient interface used to cut tissue during cataract removal of the crystalline lens | Device | Laser |
| Continuous Curvilinear Capsulorhexis (CCC)Standard-of care manual procedure (using either needles or forceps) for creating capsulorhexis, ie., opening in capsular bag during anterior segment ophthalmic surgery | Procedure or surgery | Manual |
Primary outcome
Percentage of Capsular Tears (Anterior or Posterior) During Surgery
Time frame: Day 0 (operative day)
A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.
1 secondary outcome
Operating Time in the Eye to Complete Entire Cataract Procedure
Time frame: Day 0 (operative day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Clinical Manager, Surgical study director
Alcon, A Novartis Division
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond laser and Continuous Curvilinear Capsulorhexis (CCC) in people with Intumescent Cataract, run by Alcon, a Novartis Company.
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 5 inclusion and 10 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 2 Jul 2018. 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?
Yes. Results are posted in the registry (first posted 25 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Capsular Tears (Anterior or Posterior) During Surgery (time frame: Day 0 (operative day)). 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 2 Jul 2018.