CataractPhase 3NCT02110212
Femtosecond Laser for Cataract Surgery
A Phase 3 study testing U/S Surgery and CCC and FS Laser Surgery in people with Cataract, run by Abbott Medical Optics.
Trial summary
The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- U/S Surgery and CCC and FS Laser Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Feb 2014
- Phase
- Phase 3
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to comply with the treatment/follow-up schedule and requirements
- Able to understand and provide written Informed Consent
- ETDRS visual acuity equal to or worse than 20/32 (best corrected)
- Age between 50 and 80 years old
- Pupil dilates to at least 6 mm
- Subject able to fixate
- Grade 1-4 nuclear sclerotic cataract (LOCS III)
- Axial length between 22 and 26 mm
Who cannot join
- Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
- Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
- Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
- History of prior ocular surgery
- History of ocular trauma
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- Co-existing ocular disease affecting vision
- History or current use of alpha-1 antagonist medication (e.g., Flomax)
- Known sensitivity to planned concomitant medications
About this study
Official title: A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification
The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.
- Conditions
- Cataract
- Being tested
- U/S Surgery and CCC, FS Laser Surgery
- Keywords
- Cataract, Surgery, cataract extraction, Optical devices, laser
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U/S Surgery and CCCProcedure or surgery
Also called Standard of care for U/S and CCC was required.
Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.
FS Laser SurgeryDevice
Also called OptiMedica Catalys™ Precision Laser System (Catalys System)
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| U/S Surgery and CCC | Active comparator | Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC). Receives: Procedure: U/S Surgery and CCC |
| FS Laser Surgery | Experimental | For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. Receives: Device: FS Laser Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsulotomy Dimension
Capsulotomy size will be measured during surgery for both the experimental and control groups.
Measured: Day of Surgery
Secondary outcomes (1)
Cumulative Dissipated Energy (CDE)
CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery.
Measured: Day of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionFeb 2014
Why it stopped: FDA approval received for product, no additional study subjects required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan F. Batlle, MD, Principal investigator, Laser CenterWilliam W. Culbertson, MD, Study director, Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110212
- Sponsor's protocol ID
- OMC-C-3.0
- Status last verified
- Jan 2025
- First submitted
- 8 Apr 2014
- Last updated
- 4 Feb 2025
- Results posted
- No
- 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 Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification
- ClinicalTrials.gov ID
- NCT02110212
- Acronym / sponsor ID
- OMC-C-3.0
- Conditions
- Cataract
- Keywords
- Cataract, Surgery, cataract extraction, Optical devices, laser
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA approval received for product, no additional study subjects required.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Apr 2014 (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 objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U/S Surgery and CCC | Active comparator | Procedure: U/S Surgery and CCCUltrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC). |
| FS Laser Surgery | Experimental | Device: FS Laser SurgeryFor femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able and willing to comply with the treatment/follow-up schedule and requirements
- Able to understand and provide written Informed Consent
- ETDRS visual acuity equal to or worse than 20/32 (best corrected)
- Age between 50 and 80 years old
- Pupil dilates to at least 6 mm
Key exclusion criteria (9 listed)
- Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
- Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
- Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
- History of prior ocular surgery
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 |
|---|---|---|
| U/S Surgery and CCCAlso: Standard of care for U/S and CCC was required.Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens. | Procedure or surgery | U/S Surgery and CCC |
| FS Laser SurgeryAlso: OptiMedica Catalys™ Precision Laser System (Catalys System)The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. | Device | FS Laser Surgery |
Primary outcome
Capsulotomy Dimension
Time frame: Day of Surgery
Capsulotomy size will be measured during surgery for both the experimental and control groups.
1 secondary outcome
Cumulative Dissipated Energy (CDE)
Time frame: Day of Surgery
Results and safety
The study was stopped early (reason given: FDA approval received for product, no additional study subjects required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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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.
Juan F. Batlle, MD principal investigator
Laser Center
William W. Culbertson, MD study director
Bascom Palmer Eye Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing U/S Surgery and CCC and FS Laser Surgery 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 8 inclusion and 9 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: stopped early, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: FDA approval received for product, no additional study subjects required.). Results are not available in the source record.
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?
Capsulotomy Dimension (time frame: Day of Surgery). 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.