A Study of Cataract Surgery With the Femtosecond Laser
This study has been terminated.
(Sponsor decided not to pursue market release of prototype device used in this study)
Sponsor:
Abbott Medical Optics
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT00922571
First received: June 16, 2009
Last updated: August 1, 2016
Last verified: August 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery.
| Condition | Intervention |
|---|---|
|
Cataract |
Procedure: FS Laser Surgery Device: FS Laser System |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Study of Cataract Surgery With the Assistance of the Femtosecond Laser |
Resource links provided by NLM:
Further study details as provided by Abbott Medical Optics:
Primary Outcome Measures:
- Capsulotomy Size [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]Capsulotomy size will be measured during surgery.
Secondary Outcome Measures:
- Cumulated Dissipated Energy (CDE) [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery.
| Enrollment: | 100 |
| Study Start Date: | June 2009 |
| Study Completion Date: | May 2014 |
| Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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)
|
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922571
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922571
Locations
| Dominican Republic | |
| Laser Center | |
| Santo Domingo, Dominican Republic | |
Sponsors and Collaborators
Abbott Medical Optics
Investigators
| Principal Investigator: | Juan F. Batlle, MD | Laser Center, Santo Domingo, Dominican Republic |
More Information
| Responsible Party: | Abbott Medical Optics |
| ClinicalTrials.gov Identifier: | NCT00922571 History of Changes |
| Other Study ID Numbers: | OMC-C-1.1 |
| Study First Received: | June 16, 2009 |
| Last Updated: | August 1, 2016 |
| Health Authority: | Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS) |
Keywords provided by Abbott Medical Optics:
|
Cataract Femtosecond laser |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on September 28, 2016