NCT01383057CompletedPhase 4
Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Innovative Medical
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure
Study Overview
Brief Summary
The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye.
- •Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation.
- •The surgeon may use the Mentor Potential Acuity Meter (PAM) laser interferometer, McIntyre Pinhole, or his/her judgment to estimate the patient's potential acuity.
Exclusion Criteria
- •Concurrent participation or participation in the last thirty days in any other clinical trial.
- •Known steroid IOP responder
- •Taking medications that may affect vision, IOP or ease of cataract surgery (e.g., Flomax, Glaucoma mediations, etc.)
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
- •Uncontrolled systemic or ocular disease
- •Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
- •Pseudoexfoliation
- •Ocular hypertension IOP >25 mmHg by tonometry or glaucomatous changes in the optic nerve
Outcomes
Primary Outcomes
Intraocular Pressure
Time Frame: 3 months
Measure the fluid pressure inside the eye
Uncorrected and Best corrected Visual Acuity
Time Frame: one month
Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected).
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 4
Laser Cataract Surgery With the Femtosecond Laser TechnologyCataractsNCT01382823Innovative Medical10
Terminated
Not Applicable
A Study of Cataract Surgery With the Femtosecond LaserCataractNCT00922571Abbott Medical Optics100
Unknown
Not Applicable
Corneal Epithelial Autograft for PterygiumPterygiumNCT03217500Chunxiao Wang45
Unknown
Not Applicable
Corneal Epithelial Autograft for LSCDLimbal Stem Cell DeficiencyNCT03217487Chunxiao Wang20
Completed
Not Applicable
Corneal Epithelial Allograft From Living-related Donor for LSCDLimbal Stem Cell DeficiencyNCT03217435Chunxiao Wang20