CataractNCT00922571
A Study of Cataract Surgery With the Femtosecond Laser
A study testing FS Laser Surgery and FS Laser System in people with Cataract, run by Abbott Medical Optics.
Trial summary
The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- FS Laser Surgery and FS Laser System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to May 2014
- Phase
- Interventional
- 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
- 3. ETDRS visual acuity equal to or worse than 20/30 (best corrected)
- Patient age between 50 and 80 years old
- Pupil dilates to at least 8 mm
- Patient able to fixate
- 1-3+ nuclear sclerotic cataract(This criterion does not apply to subjects who will receive post-IOL corneal relaxing incisions)
- Axial length between 22 and 26 mm
Who cannot join
- Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breast feeding
- 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
- Anterior chamber depth less than 2.5 mm via Optical Coherence Tomography (Visante, Zeiss) or IOL Master (Zeiss) measurements
- History of prior ocular surgery
- History of ocular trauma
- Co-existing ocular disease affecting vision
- Astigmatism greater than five diopters (D.)
About this study
Official title: A Study of Cataract Surgery With the Assistance of the Femtosecond Laser
The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery.
- Conditions
- Cataract
- Being tested
- FS Laser Surgery, FS Laser System
- Keywords
- Cataract, Femtosecond laser
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS Laser SurgeryProcedure or surgery
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.
FS Laser SystemDevice
Also called OptiMedica Catalys™ Precision Laser System (Catalys System)
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.
| Study group | Role | What they receive |
|---|---|---|
| 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 OptiMedica Catalys™ Precision Laser System (Catalys System) Receives: Procedure: FS Laser Surgery; Device: FS Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsulotomy Size
Capsulotomy size will be measured during surgery.
Measured: Day of Surgery
Secondary outcomes (1)
Cumulated 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 posted17 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Sponsor decided not to pursue market release of prototype device used in this study
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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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 Center, Santo Domingo, Dominican Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922571
- Sponsor's protocol ID
- OMC-C-1.1
- Status last verified
- Jan 2025
- First submitted
- 16 Jun 2009
- 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 Study of Cataract Surgery With the Assistance of the Femtosecond Laser
- ClinicalTrials.gov ID
- NCT00922571
- Acronym / sponsor ID
- OMC-C-1.1
- Conditions
- Cataract
- Keywords
- Cataract, Femtosecond laser
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided not to pursue market release of prototype device used in this study
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Jun 2009 (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 evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FS Laser Surgery | Experimental | Procedure: FS Laser Surgery, Device: FS Laser SystemFor femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the OptiMedica Catalys™ Precision Laser System (Catalys System) |
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
- 3. ETDRS visual acuity equal to or worse than 20/30 (best corrected)
- Patient age between 50 and 80 years old
- Pupil dilates to at least 8 mm
Key exclusion criteria (8 listed)
- Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breast feeding
- 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
- Anterior chamber depth less than 2.5 mm via Optical Coherence Tomography (Visante, Zeiss) or IOL Master (Zeiss) measurements
- 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 |
|---|---|---|
| FS Laser SurgeryThe Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device. | Procedure or surgery | FS Laser Surgery |
| FS Laser SystemAlso: OptiMedica Catalys™ Precision Laser System (Catalys System)The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device. | Device | FS Laser Surgery |
Primary outcome
Capsulotomy Size
Time frame: Day of Surgery
Capsulotomy size will be measured during surgery.
1 secondary outcome
Cumulated Dissipated Energy (CDE)
Time frame: Day of surgery
Results and safety
The study was stopped early (reason given: Sponsor decided not to pursue market release of prototype device used in this study). 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, Santo Domingo, Dominican Republic
Questions about this trial
What is this clinical trial studying?
A study testing FS Laser Surgery and FS Laser System 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 8 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.
Are results available for this study?
The study was stopped early (reason given: Sponsor decided not to pursue market release of prototype device used in this study). 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 Size (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.