Search / Trial NCT06225362

Quatera 700 vs. Centurion

Launched by CAROLINA EYECARE PHYSICIANS, LLC · Jan 17, 2024

Apply for Trial

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different devices used during cataract surgery, which is a common procedure to remove cloudy lenses from the eyes. The goal is to see how these devices compare in helping patients who are having cataract surgery in both eyes. The trial is currently looking for participants who are between 50 and 80 years old and are scheduled for this type of surgery. To join, participants need to be able to give their consent and attend scheduled visits, and they should not have certain eye or health conditions that could complicate the surgery.

If you decide to participate, you'll undergo standard cataract surgery with one of the devices, and you can expect to have your vision assessed afterwards. The study aims to ensure a smooth surgery experience with minimal complications and a quick recovery. It's important to note that if you have specific eye diseases or other health issues, you may not be eligible for this trial. This study could help improve future cataract surgeries and outcomes for patients like you.

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 Carolina Eyecare Physicians, Llc

Carolina EyeCare Physicians, LLC is a leading clinical research organization specializing in ophthalmology and vision-related studies. With a commitment to advancing eye care through innovative research, the organization conducts rigorous clinical trials aimed at evaluating new treatments, therapies, and technologies in the field of eye health. Their experienced team of physicians and researchers collaborates closely with regulatory bodies and industry partners to ensure the highest standards of safety and efficacy in patient care. Carolina EyeCare Physicians is dedicated to enhancing the quality of life for individuals with vision impairments while contributing to the broader scientific understanding of ocular conditions.

Locations

Mount Pleasant, South Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0