Status:
COMPLETED
Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) Clinical Investigation
Lead Sponsor:
Lenstec Incorporated
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the following clinical protocol is to evaluate the safety and effectiveness of the Lenstec Tetraflex Accommodating Posterior Chamber Intraocular Lens (IOL) for the protocol inclusion/ex...
Detailed Description
The Lenstec TetraFlex Accommodating Posterior Chamber Intraocular Lens (IOL) is an ultraviolet absorbing optical implant designed for the replacement of the human crystalline lens following phacoemuls...
Eligibility Criteria
Inclusion
- Male or Female
- Any race
- Patients age at time of surgery to be 18 years or older.
- Presence of bilateral cataract requiring cataract extraction. If only one eye is being implanted with the study lens, the other eye may have had cataract extraction with IOL implantation.
- Clear intraocular media other than cataract.
- Patients with BSCVA \< 20/40 or cataract with glare acuity worse than 20/30
- Corneal Astigmatism less than 1 Diopter.
- Good Visual Potential: Best corrected visual acuity (BCVA) projected by PAM or Pinhole 20/25 or better if other pathology is suspected.
- Patient is able and willing to comply with follow-up.
- Able to provide written informed consent.
Exclusion
- Patients who are monocular.
- Presence of an ocular infection.
- Greater than or equal to 1 Diopter of pre-operative corneal astigmatism.
- Patients who are on anti-psychotic and antidepressant medication that could potentially effect accommodation
- Patients who chronically take any medication that may affect accommodation, including first generation antihistamines, and anticholinergic agents.
- Previous intraocular surgery in either eye.
- Previous serious corneal disease.
- Diagnosis of any of the following ocular conditions: active scleral disease, glaucoma, retinal disease potentially affecting central vision, macular disease or uveitis, severe dry eyes and dysthyroid eye disease
- Subjects who may be expected to require retinal laser treatment.
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse).
- Patients requiring administration of topical ophthalmic medications other than the study medications. Use of systemic corticosteroids or anti-metabolites or other medications that could affect wound healing is specifically contraindicated.
- Allergy to anesthetics or other postoperative medications.
- Presence of any uncontrolled systemic disease (e.g. diabetes, hypertension, cardiovascular disease).
- Pregnant or lactating women
- Persons who, in the determination of the investigator, are not competent to understand the procedure, the actions asked of them as research subjects, or capable of completing the patient satisfaction questionnaire.
- Participation in a previous clinical trial within the 30 days prior to the start of the study.
- Persons who may not be able to complete the requirements of returning to the investigator's clinic over the period of the study, or who may be difficult to locate or contact on short notice. This does not preclude vacations or travel.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT00969371
Start Date
September 1 2005
End Date
June 1 2009
Last Update
October 18 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.