CataractNCT01713660
Corneal Incisions With the IntraLase iFS Femtosecond Laser System
A study testing iFS Femtosecond Laser in people with Cataract, run by Abbott Medical Optics.
Trial summary
The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- iFS Femtosecond Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jan 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 21 years of age
- Unilateral or bilateral cataract(s) for which phacoemulsification lens extraction and posterior chamber intraocular lens (IOL) implantation has been planned
- Visual potential of 20/25 or better in each study eye following cataract removal and IOL implantation
- Clear intraocular media other than cataract
- Available, willing and capable of complying with examination procedures and follow-up visits for the duration of the study
- Signed informed consent
Who cannot join
- Previous intraocular or corneal surgery, including refractive surgery in the operative eye(s)
- History of active or recurrent ophthalmic disease
- Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration or irregular astigmatism in the operative eye(s)
- White to white measurement less than 10 mm or greater than 14 mm
- Corneal pathology/abnormality that may interfere with the transmission of laser energy, laser light or precludes applanation
- Corneal pathology/abnormality that is predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study
Show all 18Show fewer
- Subjects with diagnosed degenerative visual disorders (e.g., macular or other retinal pathology) that are predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study
- Subjects with conditions associated with increased risk of IOL/capsule instability
- Pharmacologically dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities
- Prior, current, or anticipated use during the course of the study of tamsulosin, silodosin or pilocarpine (e.g. Flomax, Flomaxtra, Rapaflo)
- History of any ocular or medical conditions that could affect corneal wound healing
- Poorly-controlled diabetes or subjects with diabetic retinopathy
- Concurrent use of topical or systemic medications that may impair corneal wound healing
- Acute, chronic, or uncontrolled systemic or ocular disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)
- Ocular hypertension (> 21 mm Hg)
- Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
- Known sensitivity or inappropriate responsiveness to any of the medications used in the post operative course
- Concurrent participation or participation in any other clinical trial during the duration of this clinical study including 30 days prior to preoperative visit
About this study
Official title: A MULTI-CENTER PROSPECTIVE STUDY TO EVALUATE THE USE OF THE INTRALASE iFS™ FEMTOSECOND LASER SYSTEM TO CREATE CLEAR CORNEAL INCISIONS AND PARACENTESIS INCISIONS FOR CATARACT SURGERY
The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.
- Conditions
- Cataract
- Being tested
- iFS Femtosecond Laser
- Keywords
- Cataract surgery, Femtosecond laser, Corneal incisions
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFS Femtosecond LaserDevice
corneal incisions created by the femtosecond laser
| Study group | Role | What they receive |
|---|---|---|
| FS Corneal Incisions | Other | Not described Receives: Device: iFS Femtosecond Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.
Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).
Measured: Day 0, Operative (Within 2 hours of incision creation)
Secondary outcomes (2)
Surgeon Assessment of Workflow
Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?
Measured: Day 0, Operative
Percent of Seidel Staining
Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.
Measured: Day 0 (performed immediately post-incision creation), Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionJan 2013
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713660
- Sponsor's protocol ID
- FMTO-105-CCIP
- Status last verified
- Jan 2025
- First submitted
- 22 Oct 2012
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTI-CENTER PROSPECTIVE STUDY TO EVALUATE THE USE OF THE INTRALASE iFS™ FEMTOSECOND LASER SYSTEM TO CREATE CLEAR CORNEAL INCISIONS AND PARACENTESIS INCISIONS FOR CATARACT SURGERY
- ClinicalTrials.gov ID
- NCT01713660
- Acronym / sponsor ID
- FMTO-105-CCIP
- Conditions
- Cataract
- Keywords
- Cataract surgery, Femtosecond laser, Corneal incisions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Posted 29 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FS Corneal Incisions | Other | Device: iFS Femtosecond Laser |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 21 years of age
- Unilateral or bilateral cataract(s) for which phacoemulsification lens extraction and posterior chamber intraocular lens (IOL) implantation has been planned
- Visual potential of 20/25 or better in each study eye following cataract removal and IOL implantation
- Clear intraocular media other than cataract
- Available, willing and capable of complying with examination procedures and follow-up visits for the duration of the study
Key exclusion criteria (18 listed)
- Previous intraocular or corneal surgery, including refractive surgery in the operative eye(s)
- History of active or recurrent ophthalmic disease
- Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration or irregular astigmatism in the operative eye(s)
- White to white measurement less than 10 mm or greater than 14 mm
- Corneal pathology/abnormality that may interfere with the transmission of laser energy, laser light or precludes applanation
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 |
|---|---|---|
| iFS Femtosecond Lasercorneal incisions created by the femtosecond laser | Device | FS Corneal Incisions |
Primary outcome
Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.
Time frame: Day 0, Operative (Within 2 hours of incision creation)
Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).
2 secondary outcomes
Surgeon Assessment of Workflow
Time frame: Day 0, Operative
Percent of Seidel Staining
Time frame: Day 0 (performed immediately post-incision creation), Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing iFS Femtosecond Laser in people with Cataract, run by Abbott Medical Optics.
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 18 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 4 Feb 2025. 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 29 May 2013). 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?
Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions. (time frame: Day 0, Operative (Within 2 hours of incision creation)). 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 4 Feb 2025.