A Study of Cataract Surgery With the Femtosecond Laser
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ClinicalTrials.gov Identifier: NCT00922571 |
Recruitment Status
:
Terminated
(Sponsor decided not to pursue market release of prototype device used in this study)
First Posted
: June 17, 2009
Last Update Posted
: August 3, 2016
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Condition or disease | Intervention/treatment | Phase |
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Cataract | Procedure: FS Laser Surgery Device: FS Laser System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | A Study of Cataract Surgery With the Assistance of the Femtosecond Laser |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: FS Laser Surgery
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)
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Procedure: FS Laser 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.
Device: FS Laser 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.
Other Name: OptiMedica Catalys™ Precision Laser System (Catalys System)
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- Capsulotomy Size [ Time Frame: Day of Surgery ]Capsulotomy size will be measured during surgery.
- Cumulated Dissipated Energy (CDE) [ Time Frame: Day of surgery ]CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery.

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Ages Eligible for Study: | 50 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922571
Dominican Republic | |
Laser Center | |
Santo Domingo, Dominican Republic |
Principal Investigator: | Juan F. Batlle, MD | Laser Center, Santo Domingo, Dominican Republic |
Responsible Party: | Abbott Medical Optics |
ClinicalTrials.gov Identifier: | NCT00922571 History of Changes |
Other Study ID Numbers: |
OMC-C-1.1 |
First Posted: | June 17, 2009 Key Record Dates |
Last Update Posted: | August 3, 2016 |
Last Verified: | August 2016 |
Keywords provided by Abbott Medical Optics:
Cataract Femtosecond laser |
Additional relevant MeSH terms:
Cataract Lens Diseases Eye Diseases |