Quatera 700 vs. Centurion
Launched by CAROLINA EYECARE PHYSICIANS, LLC · Jan 17, 2024
Trial Information
Current as of October 03, 2024
Recruiting
Keywords
Description
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * Subject is undergoing bilateral lens extraction with implantation of a posterior chamber intraocular lens.
- * Gender: Males and Females.
- * Age: 50 to 80 years old. Solomon KD, DeOliveira A, Sandoval HP 4 CONFIDENTIAL CEP 23-002 Version 1.0/27Jul2023
- * Willing and able to provide written informed consent for participation in the study
- * Willing and able to comply with scheduled visits and other study procedures.
- * Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 1 to 30 days between surgeries
- * Subjects requiring an IOL power in the range of +10.0 D to +30.0 D only.
- * Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
- Exclusion Criteria:
- * Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- * Uncontrolled diabetes.
- * Use of any systemic or topical drug known to interfere with visual performance.
- * Contact lens use during the active treatment portion of the trial.
- * Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
- * Clinically significant corneal dystrophy.
- * Corneal irregularities potentially affecting visual acuity: keratoconus, corneal dystrophy, corneal opacities.
- * Endothelial cell count less than 1500 cells/mm2
- * History of chronic intraocular inflammation.
- * History of retinal detachment.
- * Femtosecond arcuates at time of surgery.
- * Femtosecond laser assisted cataract surgery in one eye only.
- * Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- * Previous intraocular surgery.
- * Previous radial keratoromy (RK).
- * Previous keratoplasty
- * Pupil abnormalities
- * Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e. LASIK)
- * Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
- * Other ocular procedures at the time of the cataract extraction (i.e., iStent)
- * Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- * Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
About Sponsor
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Mount Pleasant, South Carolina, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0